Wednesday, November 11, 2026

Long term followup of our patients having surgery is critical but difficult

Patients considering shoulder surgery ask their surgeon, “How will my shoulder be doing years from now?” Not at two years – at ten and twenty years after surgery, when the 50-year-old will be older but still wanting to be able to work, garden, play with the kids and sleep comfortably.

Often the best data we can provide are two-year results from the fraction of patients who provided follow-up after their procedure. An important study from the University of Utah [1] found that even when a very well-motivated surgeon personally tried to contact 1,028 of his surgical patients by telephone, text and email, only 49% provided two-year follow-up. Younger patients and those having instability surgery – the patients with the most years ahead of them – were the most likely to be lost to follow-up.

There is no way to know how patients without followup are doing. Our own study of patients with rotator cuff tears showed how misleading that gap can be [2]. Patients who stopped returning mailed questionnaires could perform far fewer Simple Shoulder Test functions at their last report than those who kept responding (3.3 vs. 7.9 of 12). Even the way we ask changes the answer: responders reported the ability to perform more functions when asked by a phone call from a real person than when asked by mail.

Over ten or twenty years, many things change: implants appear and disappear, surgeons refine their techniques and their selection of patients, some patients die and others move or stop responding, barriers to returning for follow-up grow, and the measures of outcome change. Long-term studies in shoulder arthroplasty have captured as few as one-fifth and at most about one-half of the patients who had the operation [3].

Why does follow-up matter? Long-term follow-up improves the care of patients in two ways. First, it informs our specialty about what works well and what doesn't – which operations, implants and techniques serve patients well over the decades, and which fail late. Second, it informs each surgeon about what works and what doesn't in that surgeon's own hands. The surgeon is the method. A surgeon who asks how each patient is doing, studies every adverse outcome and adjusts their method accordingly is engaged in recursive self-improvement: each cycle makes the next one better. A surgeon who does not know their outcomes is not learning from their failures.

The anatomic glenoid component illustrates why both matter. Glenoid component failures are rarely noted in the first five years after total shoulder arthroplasty, then become progressively more common: in one multicenter series, survival free of radiographic loosening fell from 99% at five years to 34% at fifteen [4]. When we used a now outdated implant system, patients whose glenoid components failed had their self-assessed function fall back to their preoperative levels at a mean of seven years after surgery – long after a two-year study would have been closed [5].

Our challenge

As a specialty, we need a practical way to capture outcomes for as many of our patients as possible, for as long as possible – one that works across the specialty and in the everyday practice of community surgeons. It must be easy for patients, so that taking part is not a burden (for example, it can't require repeated office visits). And it must be easy for surgeons and investigators to request, record and analyze the results. Simple measures that capture most patients for decades are worth more than detailed measures on a few.

What is the simplest question we could ask every patient, every year, that would tell us what we most need to know?

 

The rest of this post makes the case in detail.

Why follow-up matters for the field

•       Informed Consent. Patients should know their chances of being better than before, of further surgery and of complications – over the years that matter to them. Without long-term data from a representative group of patients, we can only guess, and our guesses may well be over-optimistic.

•       Late failures declare themselves late. The anatomic glenoid component is the clearest example. In a European multicenter study of 226 total shoulder arthroplasties with a cemented, all-polyethylene, keeled glenoid component, survival free of glenoid revision was 99.1% at five years, 94.5% at ten and 79.4% at fifteen; survival free of radiographic loosening was 99.1%, 80.3% and 33.6% [4]. The authors noted that revision and loosening increased with time, but not until after five years, and recommended that studies of new glenoid designs report follow-up of at least five to ten years. Other late failures are similar: in one long-term series of reverse total shoulder arthroplasty, 10 of the 47 complications occurred at a mean of 8.3 years after surgery [6], and among 359 failed hemiarthroplasties revised at our referral center, 45% were revised two or more years after the index operation and 18% after five or more years [7]. A two-year study sees none of these.

Glenoid component survival after anatomic total shoulder arthroplasty, plotted from Young et al. [4]. The shaded band marks the period covered by a typical two-year study.

•       Laboratory promise must be confirmed in patients. In the early 1990s, a new polyethylene, Hylamer, was used for the glenoid component of a widely used shoulder system because laboratory testing showed improved strength and resistance to creep and wear [8]. After implantation, however, components sterilized by gamma irradiation in air oxidized, became brittle and eroded. The problem surfaced only as surgeons following their patients began revising failed components and comparing what they found – cracking, delamination, fragmentation and abnormal wear. In one surgical team's revisions, the mean time from the index arthroplasty was 36.8 months (range, 32 to 99 months). The authors recommended monitoring patients with these components at six-month intervals, and concluded that each new bearing surface should be closely monitored clinically and radiographically to determine whether it functions as well in patients as it did in the laboratory.

•       Implants and techniques need surveillance. New implants, modifications and techniques enter practice constantly, and none has a long-term record when it arrives. Only follow-up – by registries and by surgeons – reveals which ones serve patients well and which fail. In registries, though, the long term follow-up data may be on implants that are no longer in use.

•       Implant survival is not patient outcome. Revision-free survival is easy to measure, but a retained implant may be painful, unstable or functionless. In the long-term reverse arthroplasty series cited above [6], prosthetic survival was 93% at a mean of more than 12 years, yet clinical scores had declined significantly from the medium-term evaluation. Only asking patients tells us how they are doing.

•       Choosing among treatments. Comparing operations – anatomic or reverse arthroplasty, one design or another – requires knowing how each performs over the long term in similar patients. Comparisons built on two-year data, or on the minority of patients who remain in follow-up does not provide the information we need.

Why follow-up matters for the surgeon: recursive self-improvement

As craftsmen, each of us wants to get better at our craft. In surgery, the surgeon is the method: the choice of patient, the choice of operation, the technique and the aftercare all pass through the surgeon's judgment and hands. Improving outcomes for future patients means improving the surgeon's method.

Improvement requires feedback. A surgeon who operates, learns how the patient is doing, studies what went wrong when the outcome is adverse, and adjusts the method for the next patient closes the loop. Each pass through the loop improves the method that will be applied to every subsequent patient – and each improved patient outcomes becomes new information. That is recursive self-improvement, and it is how a surgeon's method becomes progressively better over a career.

Without follow-up, the loop is open. Experience without feedback is repetition, not learning. Worse, the feedback a surgeon does receive may be biased: the patients who keep returning may be disproportionately those who are doing well, while the unhappy patient who moves her care elsewhere, or the shoulder revised by another surgeon, never report back. A surgeon can come to believe that their results are better than they are. The failures that wander off are exactly the ones with the most to teach.

An example from our own practice. Between 1992 and 1997, 115 primary total shoulder arthroplasties for osteoarthritis were performed with a standardized technique with a certain glenoid component, and patients were mailed the Simple Shoulder Test (SST) every six months [5]. In the shoulders later revised by the original surgeon for isolated glenoid component failure, the SST had risen from a mean of 4.4 before surgery to 11.3 after it, then fallen to 4.6 – essentially the preoperative level – at a mean of 7.4 years (range, 2.9 to 11.1 years). Every one showed a drop of at least three SST functions from its peak, and in over half the drop appeared more than a year before the patient came in for evaluation. Periodic self-assessment told the surgeon, in his own practice and with his own technique, which shoulders were failing and when – information that no two-year study and no annual office visit schedule would have provided. As the authors noted, these failures occur beyond the duration of routine postsurgical follow-up, and the need to monitor patients persists throughout the life of the arthroplasty. With this information, use of that glenoid component was discontinued.

Because most of what we do turns out well, the greatest opportunity for improvement lies in the instances in which the outcome was adverse. Learning of those instances – wherever and whenever they occur – is the purpose of follow-up for the surgeon.

The evidence: who is lost, and what we don't know

The Utah study. The authors reviewed 1,028 consecutive patients who had shoulder surgery by a single surgeon between 2017 and 2022 [1]. At two years, every patient was personally contacted by the surgeon by telephone, text and email, followed by automated messages through the electronic medical record; a response by any method counted. Only 507 (49%) completed follow-up. Those who responded were older (mean 53 versus 49 years), more often had an arthroplasty and were more often insured by Medicare; patients having instability surgery and those with Medicaid or Workers' Compensation were more often lost. In the final model, younger age and a missing preoperative pain score independently predicted loss to follow-up, while current alcohol use predicted better follow-up. Neither the Social Deprivation Index nor distance from the hospital predicted follow-up. Importantly, preoperative Subjective Shoulder Value (48 versus 47) and pain scores (4.7 versus 4.6) did not differ between those who responded and those who did not.

This was big-effort study; a 49% response is what the diligent effort produced. But the study tells us who was lost, not how they fared. Similar starting scores tell us that responders and nonresponders began in the same place, not where they ended up.

What happens to the patients who stop answering? More than 25 years ago, we mailed the Simple Shoulder Test (SST) and the SF-36 every six months to 224 patients with full-thickness rotator cuff tears [2]. Sixty-seven (30%) responded regularly, 55 (25%) occasionally, and 102 (46%) stopped responding.

•       Those who later stopped had preoperative SST scores similar to those who kept responding (4.69 versus 5.09), though lower SF-36 social function and mental health scores.

•       On their last mailed questionnaire, the nonresponders were doing much worse than the responders: mean SST 3.26 versus 7.85. 

•       The method of asking mattered: 30 randomly chosen responders scored 9.03 by telephone and 7.47 by mail within the same month. 

Two lessons follow. A patient's last known status may not be the current status. And scores obtained by different methods cannot simply be pooled. 

A little arithmetic. Suppose 50 of 100 patients treated responded and that 80% of the patients who responded reported an improvement exceeding the minimal clinically important difference (MCID). What we know is that 40% of all patients treated reached the MCID. The true figure for the overall percent of patients reaching the MCID could lie anywhere from 40% (if none of the nonresponders improved) to 90% (if all of them did). Reporting 80% clinically significant improvement assumes that the nonresponders did exactly as well as the responders-something we cannot know.

Hypothetical: 100 patients treated, 50 respond

Patients reaching MCID

Reported rate

Responders (40 of 50 improved)

40

80% of responders

None of the 50 nonresponders improved

40

40% of all treated

All of the 50 nonresponders improved

90

90% of all treated

 

The patients most often lost are those for whom long-term results matter most. Younger patients and patients having instability surgery were the least likely to respond. They are the ones with the most years ahead, the highest demands on their shoulders and the greatest concern about durability. 

Why long-term follow-up is so hard: a lot happens over the long term

•       Implants rise and disappear. The humeral and glenoid components a patient received 10 or 20 years ago may no longer be made, and today's implants have no long-term record at all.

•       Surgeons change. With experience, surgeons refine their technique and their selection of patients for each operation. Results of a surgeon's early cases may not represent the same surgeon's later ones.

•       Frail patients die. Their outcomes are neither successes nor failures, but their deaths leave a healthier group of survivors to be studied.

•       Unhappy patients wander off. Dissatisfied patients may move their care to another surgeon or have a revision that ends follow-up of the original operation; patients with complications and revisions tend to be lost.

•       Barriers to follow-up grow. Over the years patients move, become ill, find travel harder or costlier, and tire of questionnaires.

•       Metrics change. The scores in use change over the decades, and so does how they are presented to the patient – in the office, by mail, online or by telephone – which, as shown above, can change the score itself.

•       The sample shrinks. What remains is a small and potentially unrepresentative fraction of the patients who had the operation.

Each of these changes the group being studied between the day of surgery and the final follow-up. The patients reporting at ten years are not the cohort that had the operation, and the operation they had may not be the one being offered today.

Examples. A systematic review of reverse total shoulder arthroplasty with a minimum of 10 years of follow-up combined seven case series and 469 procedures [3]. The weighted mean loss to follow-up was 63% (range 47% to 80%); the studies used different scores (absolute and relative Constant score, Subjective Shoulder Value, ASES, SANE) and different methods of follow-up. Revision-free survivorship was reported as 88% at 10 years, yet quizzically 36% of patients had complications and 23% needed further revision. The 469 procedures were fewer than 1% of the 63,845 reverse arthroplasties performed in the United States in 2017 alone [9] - this small sample is unlikely to be representative of the overall picture.

In one series, 191 reverse arthroplasties were followed for a mean of 150 months [6]. By then, 79 prostheses were in patients who had died and 17 had been lost; clinical data were available for 87 - just over half.

A comparison of pegged and keeled cemented glenoid components from a single practice yielded a matched cohort of 36 shoulders at a mean of about nine years – a small fraction of the more than 600 total shoulder arthroplasties performed in that practice between 2001 and 2015 [10]. Many of the components studied are no longer in common use. 

Our own experience is similar. In our study of anatomic total shoulder and ream-and-run arthroplasty with a minimum of 10 years of follow-up, 63 of the 127 eligible patients (50%) responded [11]. In our ream-and-run study at a minimum of five years, 228 of 333 patients agreed to follow-up beyond two years, and data were available for 201 – 60% of the patients who had the operation [12]. The results among those we heard from were good, but they are the results from the responders.

A final caution: comparing the mean score of the patients available at two years with the mean score of the smaller group available at ten years does not tell us whether shoulders change over time, because the two groups are different patients. Change over time is better studied by following the same patients at each interval.

A path forward, part 1: decide what we need to know, and make it easy to collect

Long-term follow-up is worth its cost only if it answers a question that matters today. Before starting, we need to decide what question is to be answered, and how many patients – both the number and the percentage of the original cohort – and how long a follow-up is needed to answer it.

A small core set of information, collected the same way at every interval, may serve better than an elaborate one:

•       Is the patient alive, and is the original implant still in place? Deaths and revisions are outcomes, not reasons to drop a patient from the analysis.

•       Has there been any further surgery on this shoulder, by anyone, anywhere – when, and why? Asking the patient directly is the most practical way to learn of revisions performed by other surgeons.

•       Comfort and function, self-assessed, item by item. "At ten years, 80% could sleep comfortably on the operated side" is information a patient can use.

•       The patient's overall judgment. "Would you have the surgery again?" or "Are you satisfied?"

Is "Are you happy you had the surgery?" sufficient? It is a valuable, nearly cost-free summary of the patient's own judgment. But it cannot stand alone. It blends the shoulder with expectations, gratitude, the relationship with the surgeon and how bad things were before; it clusters near the top of the scale; and it does not tell the next patient which functions to expect.

ASES, Constant or SST? The Constant score requires an examination and strength testing – a visit – which raises exactly the barrier that drives attrition. The patient-reported section of the ASES score can be completed remotely, but it yields a single weighted number. The Simple Shoulder Test asks 12 yes-or-no questions about specific functions, takes a couple of minutes, can be completed from anywhere and reports each function separately. Whatever the choice, the essential thing is to choose one measure and keep it – and to keep, or at least record, the method of administration.

Do we need radiographs? Not for every patient at every interval. Radiographs require a visit, and several common radiographic findings have shown weak relationships to patient-reported outcome; in our ream-and-run series, for example, glenoid medialization was not associated with the SST result [13,14]. Radiographs are essential when the question is about structure – how glenoid wear progresses, whether a design loosens – in which case standardized, comparable views (such as the axillary truth view) should be planned for a defined group of patients. They are also needed when a patient develops new symptoms. Whether periodic surveillance radiographs of asymptomatic shoulders improve outcomes by detecting silent failure early is plausible but not shown.

Making it easy to collect:

•       Consent every patient for long-term follow-up before surgery, explaining why it matters; obtain a preoperative baseline; and organize automated reminders at fixed intervals – for example 1, 2, 5, 10, 15 and 20 years.

•       Follow each patient's own trajectory over time, rather than comparing different groups of patients at different intervals.

•       Report the follow-up rate with the characteristics of those lost, and report outcomes both as a percentage of those who responded and as a percentage of all patients treated.

A path forward, part 2: since the surgeon is the method, learning from failure

Even complete long-term follow-up yields averages, and averages from past patients do not predict the outcome for the individual patient in front of us [15]. What we can do is improve the method – ourselves.

Population registries. One of the world's most comprehensive population-based resources, the Australian Orthopaedic Association National Joint Replacement Registry [16], can inform the implants we choose, the implant modifications we adopt and the types of adverse outcome we can expect to encounter. Registries capture revisions wherever they are performed – precisely the failures that individual series miss.

Counterfactual analysis of failures. A complementary approach asks of each failure the counterfactual question: what might have been done differently to lower the risk of this complication [17,18]? 

Personal continuous quality improvement. Each of us can learn from our own adverse outcomes, and the approach is straightforward [19]. For each adverse outcome in our own practice:

(1)   Identify the mode of failure (for example, a displaced acromial stress fracture after reverse total shoulder arthroplasty).

(2)   Identify the important parameters of our treatment (for example, the position of the glenosphere and humeral component).

(3)   Compare these parameters in the case with those in similar patients in our own practice who did not have the complication.

(4)   Note the differences and consider adjusting our technique in the direction of the controls (for example, making sure that the distance from the glenosphere center of rotation to the acromion is greater than the distance from the glenosphere center of rotation to the greater tuberosity).

This intrapractice analysis does not require a large cohort or decades of follow-up: every adverse outcome is information, whenever it occurs. But it does require that we learn of our failures. The patients who wander off, the revisions performed elsewhere and the shoulders that fail after a study's window has closed are exactly the cases from which we could learn the most. 


The bottom line

Follow-up is how we learn which operations serve patients over the decades they care about. For the surgeon, it is the feedback loop through which each failure improves the care of the next patient. When a patient asks what their shoulder will be like in ten or twenty years, the honest answer today too often begins with what we know at two years among the half who answered. We can do better: decide in advance what we need to know, make it easy for patients to tell us, capture revisions and deaths wherever they occur, and study every adverse outcome to improve the method that matters most – ourselves.

Epilogue

Reference [5] demonstrates a possible approach for long-term followup in an individual surgeon's practice. Of 115 total shoulders, 12 had revision by the index surgeon for glenoid component loosening. Simple Shoulder Test scores were solicited annually after surgery. They averaged 4.4 out of 12 before surgery, rose to a mean of 11.3 after surgery and fell to a mean of 4.6 before revision surgery performed at an average of 7 years after the index arthroplasty. The charts below show the individual data for each of the 12 patients. The vertical axis shows the SST score, the horizontal axis shows the time after the index procedure. The last data point for each patient is the SST score prior to revision. What is remarkable about these data is the variability in the post operative SST pattern. Some patients reported good scores up to the point of a dramatic drop, while others had a progressive drop in scores over the years after an initially good response.

This example demonstrates that obtaining a singe score, such as the SST, may be a practical method for following patients after surgery and that a drop in the score may suggest the need for the patient to come back to the office for evaluation and X-ray.



Looking

Short eared owl

The author of this post has no financial relationship with any orthopaedic company.


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References

1.     Soule S, Smith A, Staten T, Kirkham M, Zhang C, Presson A, Joyce CD, Tashjian RZ, Chalmers PN. Predictors of loss to long-term follow-up after shoulder surgery. J Bone Joint Surg Am. 2026;108(19):1536-42. doi:10.2106/JBJS.25.00767

2.     Norquist BM, Goldberg BA, Matsen FA 3rd. Challenges in evaluating patients lost to follow-up in clinical studies of rotator cuff tears. J Bone Joint Surg Am. 2000;82(6):838-42.

3.     Biner M, Klotz S, Andronic O, Karczewski DC, Zingg L, Karl W, Kriechling P. Long-term outcomes following reverse total shoulder arthroplasty: a systematic review with a minimum follow-up of 10 years. JBJS Open Access. 2025;10(2):e25.00025. doi:10.2106/JBJS.OA.25.00025

4.     Young A, Walch G, Boileau P, Favard L, Gohlke F, Loew M, Molé D. A multicentre study of the long-term results of using a flat-back polyethylene glenoid component in shoulder replacement for primary osteoarthritis. J Bone Joint Surg Br. 2011;93(2):210-6. doi:10.1302/0301-620X.93B2.25086

5.     Buckingham BP, Parsons IM 4th, Campbell B, Titelman RM, Smith KL, Matsen FA 3rd. Patient functional self-assessment in late glenoid component failure at three to eleven years after total shoulder arthroplasty. J Shoulder Elbow Surg. 2005;14(4):368-74.

6.     Bacle G, Nové-Josserand L, Garaud P, Walch G. Long-term outcomes of reverse total shoulder arthroplasty: a follow-up of a previous study. J Bone Joint Surg Am. 2017;99(6):454-61.

7.     Hackett DJ Jr, Hsu JE, Matsen FA 3rd. Primary shoulder hemiarthroplasty: what can be learned from 359 cases that were surgically revised? Clin Orthop Relat Res. 2018;476(5):1031-40. doi:10.1007/s11999.0000000000000167

8.     Rockwood CA Jr, Wirth MA. Observation on retrieved Hylamer glenoids in shoulder arthroplasty: problems associated with sterilization by gamma irradiation in air. J Shoulder Elbow Surg. 2002;11(2):191-7.

9.     Wagner ER, Farley KX, Higgins I, Wilson JM, Daly CA, Gottschalk MB. The incidence of shoulder arthroplasty: rise and future projections compared with hip and knee arthroplasty. J Shoulder Elbow Surg. 2020;29(12):2601-9.

10.  Duey AH, Corvi JJ, Li T, Park A, Etigunta S, Patel AV, Bienstock D, Ranson W, Kantrowitz DE, Hurley E, Shukla D, Parsons BO, Flatow EL, Cagle PJ. Long-term clinical and radiographic outcomes of pegged vs. keeled glenoid components in total shoulder arthroplasty: a matched cohort study. J Orthop. 2025;65:290-5.

11.  Sharareh B, Whitson AJ, Matsen FA 3rd, Hsu JE. Minimum 10-year follow-up of anatomic total shoulder arthroplasty and ream-and-run arthroplasty for primary glenohumeral osteoarthritis. J Shoulder Elbow Surg. 2024;33:1276-84. doi:10.1016/j.jse.2023.08.028

12.  Stenson JF, Collins AP, Yao JJ, Sharareh B, Whitson AJ, Matsen FA 3rd, Hsu JE. Factors associated with success of ream-and-run arthroplasty at a minimum of 5 years. J Shoulder Elbow Surg. 2023;32:S85-S91. doi:10.1016/j.jse.2023.01.024

13.  Somerson JS, Neradilek MB, Service BC, Hsu JE, Russ SM, Matsen FA 3rd. Clinical and radiographic outcomes of the ream-and-run procedure for primary glenohumeral arthritis. J Bone Joint Surg Am. 2017;99:1291-304.

14.  Collins AP, Sheth MM, Stenson JF, Kahsai EA, Khoo KJ, Ogunleye T, Whitson AJ, Matsen FA 3rd, Hsu JE. Characterizing glenoid wear after hemiarthroplasty with concentric glenoid reaming: a study of 113 arthroplasties at a mean of 6.7 years of follow-up. J Shoulder Elbow Surg. 2026;35:995-1002.

15.  Matsen FA 3rd. Objective ignorance: a flaw in our ability to predict patient outcomes. J Bone Joint Surg Am. 2025;107(22):2508-11. doi:10.2106/JBJS.25.00638

16.  Australian Orthopaedic Association National Joint Replacement Registry. https://aoanjrr.sahmri.com/

17.  Menendez ME, Matsen FA 3rd. Learning from surgical failures. J Bone Joint Surg Am. 2026;108(8):547-8. doi:10.2106/JBJS.25.01110

18.  Matsen FA 3rd. Shoulder arthroplasty failure research. Shoulder Arthritis Blog, August 2025. https://shoulderarthritis.blogspot.com/2025/08/shoulder-arthroplasty-failure-research.html

19.  Matsen FA 3rd. How a surgeon can learn from their own adverse outcomes – an example of intrapractice analysis in reverse shoulder arthroplasty. Shoulder Arthritis Blog, January 2026. https://shoulderarthritis.blogspot.com/2026/01/how-surgeon-can-learn-from-their-own.html

Sunday, November 8, 2026

To Patch or Not To Patch in Cuff Repairs

The Summary

A patch may make the cuff-repaired shoulder tendon look better on MRI. However, robust evidence is lacking that patient-reported outcomes are clinically significantly better for patients having cuff repairs with a patch than those with unpatched repairs.

Rotator cuff repair is one of the most common operations in orthopaedics. However, the repaired tendon does not always stay attached to the bone: on MRI, roughly a quarter of repairs show a retear within a year or two. This is especially the case for the most common type of cuff pathology: the degenerative tear, the repair of which is at risk for failure because of the limited quantity and quality of the muscle, tendon, bone unit required for cuff function.

Biologic patches are commonly used with the goal of improving the outcomes of cuff repair. For example, the bovine bioinductive patch (Regeneten) is a thin sheet of purified collagen from cow tendon. The surgeon sutures it over the repaired tendon, and the body is meant to grow new tendon-like tissue into it. In August 2025 the American Academy of Orthopaedic Surgeons gave the patch its highest grade of endorsement, a “strong” recommendation, saying it can lead to lower retear rates and better patient-reported outcomes.

The first half of that statement is supported. The second half appears to lack solid evidence.

Two trials, two different questions

The AAOS recommendation rests on two randomized trials of the same implant. The larger one, from Spain and supported in part by the manufacturer, randomized 124 patients with fully repairable tears 1 to 4 cm across (on average about 2 cm) to a standard repair with or without the patch. At two years, 12% of patched repairs had retorn on MRI, compared with 35% of unpatched ones. But the patients’ ratings of pain and function were the same in both groups at every visit. The authors titled their two-year report “a lower retear rate but similar outcomes.”

The smaller trial, of 60 patients at one center, asked a different question: could the patch replace a repair altogether in small tears (2.5 cm or less, with the rotator cable intact)? Those patients did score better: 8 points higher on the ASES shoulder score, but this difference is not clinically significant (less than the minimal clinically important difference).

In other words, neither trial showed an important difference in patient comfort and function.

Why a healed tendon does not necessarily lead to a better shoulder

A meta-analysis of 20 randomized trials of biologic augmentation helps explain the paradox. Shoulders whose repairs stayed intact scored better than those that retore, by about 14 points on the ASES and 10 on the Constant. But about three of four repairs heal anyway without augmentation, so augmentation prevented a retear in only about 12 of every 100 shoulders. If augmentation were applied to all cuff repairs, the average gain would be 1 to 2 points per patient on the 100-point ASES and Constant shoulder scores, far too small a benefit for the average patient to notice.

Other studies suggest that a retear has less impact on patient comfort and function than the appearance on MRI might imply. Pooled data from more than 3,000 repairs found that patients with retorn tendons scored only 6 to 7 points lower than those whose tendons healed, and most were satisfied.

The cost

The patch adds time and expense to surgery: estimates range from $5,000 to $10,000 per case. Non industry sponsored studies have also reported a downside that the AAOS guideline does not mention: stiffness. In one matched comparison, 9% of patched shoulders needed a second operation for inflammation and stiffness, compared with none of the unpatched ones. In another, six of 32 patched shoulders and none of 32 controls were reoperated for stiffness.

“What’s New in Sports Medicine” and “What’s New in Shoulder and Elbow Surgery”

The 2026 “What’s New” reviews in the Journal of Bone & Joint Surgery report the same pattern for other add-ons to cuff repair. Injected skin cells, drilling the bone and an osteoporosis drug each improved the tendon’s appearance on MRI without a clinically meaningful change in patient reported outcomes. Neither review mentions patches.

Readers of patch reports should be wary of conclusions from reviews. A 2026 study found that 13 of 16 published reviews of patch augmentation contained “spin” in their abstracts, presenting results more favorably than the data supported.

What patients and surgeons can ask

None of this means the patch never helps. For massive tears or poor-quality tendon, where retears are most likely, patches may prove worthwhile over the long haul, but most trials have followed patients for only one to two years. Until a trial shows that patients have better long-term comfort and function, the burden of proof falls on the proponents of the device. We can reasonably ask: Will it make the shoulder feel and work better? What will it add to the cost? What is the risk that it will make the shoulder stiff?


The details

Many shoulder surgeons are using bioinductive patches in rotator cuff repair. The evidence offered for patches is based mostly on MRI images, histology and retear rates. Robust evidence of a clinically significant improvement in patient comfort and function with their use is lacking. Recent JBJS “What’s New” articles review a series of randomized trials in which adjuncts to cuff repair improved healing on MRI without a clinically significant improvement in patient-reported outcomes [1,2]. One states that optimizing the biological environment after cuff repair “remains a challenge” [2]. Neither article mentions patch augmentation.

What the 2026 “What’s New” articles report

Both updates review a year of randomized trials in rotator cuff surgery [1,2]. The cuff trials they chose share a pattern: the adjunct improves the tendon on MRI; the patient outcomes are not different.

•    Autologous dermal fibroblast injection. Retear at 6 months fell from 24.3% to 5.6%, with no difference in ASES, Constant or SST scores [3].

•    Bone marrow stimulation. Incomplete healing at 2 years fell from 54.7% to 33.9%, but ASES scores were 89.2 and 87.8 (p = 0.498) [4].

•    Zoledronic acid. Retear at 6 months fell from 35% to 15%, with what the authors of the update called “modest” clinical improvement [1,5].

If a lower retear rate reliably meant a better shoulder, at least one of these trials should have shown a difference in patient-reported outcome at the minimal clinically important difference (MCID). None did.

What the pooled randomized trials show

Our recent meta-analysis of 20 Level I randomized trials (1,327 shoulders) of biologic augmentation confirms this pattern [6]. Augmentation lowered the retear rate from 26.7% to 14.8% (risk ratio 0.62). For patch augmentation alone (153 shoulders), the retear rate was 17.6%, a risk ratio of 0.55 [6]. Yet no patient-reported outcome improved by the MCID. The pooled differences were 0.9 points for the ASES and 2.2 points for the Constant score. In the patch subgroup the Constant score was only 3.9 points higher, and the ASES was not different [6].

Why does a healed tendon not translate into a better result? Intact repairs did score 14.3 ASES points and 10.5 Constant points higher than retorn repairs [6]. But because about 73% of unaugmented repairs heal, augmentation prevents a retear in only about 12 of every 100 shoulders. Spread across all the patients who receive it, the expected gain in outcome score per patient is only 1.3 to 1.7 points [6]. 

Other meta-analyses suggest that even this gap may overstate what a retear costs the patient. Across 43 study arms (3,350 repairs, 25% retorn at a median of 18 months), healed repairs scored only 6.1 Constant points and 7.1 ASES points higher than retorn repairs, both values are below the commonly used MCIDs. The authors concluded that most patients can expect satisfactory outcomes despite a retear [7]. An earlier meta-analysis of Level I and II studies found no difference in ASES between intact and retorn repairs; strength was the clearest difference [8].

“Healed” on MRI may also not mean healed where the tendon was fixed. In a study using tantalum markers in the repaired tendon, all 13 repairs retracted from their point of fixation during the first year, by 16 mm on average, yet only 4 showed a defect on MRI [9]. The MRI retear rate is thus an imperfect measure of the tendon’s condition, and a weak predictor of how the patient will do.

A second 2026 meta-analysis, of 9 randomized trials (556 patients) of biologic grafts, found a similar structural effect from augmentation: a retear risk ratio of 0.31 and tendons 1.2 mm thicker [10]. Its abstract reports the patient-reported outcomes only as improvement from before to after surgery, which occurs with or without a graft, and concludes that greater clinical improvement with augmentation was “less consistent” [10].

The AAOS strong recommendation for patches

The 2025 AAOS guideline states that “the use of bioinductive tendon implants to augment rotator cuff repair or as an alternative to non-augmented repair can lead to lower retear rates and better patient-reported outcomes” [11]. It grades the evidence High and the recommendation Strong. By the guideline’s own definition, Strong requires two or more high-quality studies “with consistent findings” [11]. The two studies are randomized trials of the same bovine collagen implant (Regeneten); the larger one received financial support from the manufacturer [12,13].

Trial

Patients and comparison

Imaging

Patient-reported outcomes

Ruiz Ibán et al. [12,13]

124 posterosuperior tears 1–4 cm across (mean about 2 cm), retraction ≤3 cm, fully repairable; transosseous-equivalent repair with vs. without patch

Retear at 2 years 12.3% vs. 35.1%

No difference in ASES, Constant, pain or EQ-5D; ASES MCID reached by 91% vs. 88%

Camacho Chacón et al. [14]

60 supraspinatus tears ≤2.5 cm with intact rotator cable; patch instead of repair vs. sutured repair

Better tendon histology at 6 months

ASES 88 vs. 80 at 2 years, a difference below the MCID

 

The guideline’s rationale acknowledges that in the larger trial “functional outcomes did not demonstrate any differences” [11]. That trial’s 2-year report, which the guideline does not cite, is titled “a lower retear rate but similar outcomes” [13]. The smaller trial asked a different question: can a patch replace a repair in a small tear with an intact rotator cable? Its 8-point ASES difference is below the MCID [14].  The two trials do not provide strong evidence of improved clinical outcomes for patients having patches used in their cuff repair

Neither trial studied the tears for which augmentation is most often proposed. The larger trial enrolled only fully repairable tears 1 to 4 cm across, with tears averaging about 2 cm; it excluded tendons retracted more than 3 cm and muscles with Goutallier grade 3 or 4 fatty infiltration [12,13]. The smaller trial enrolled only tears of 2.5 cm or less with an intact rotator cable [14]. Massive tears and tears with poor-quality tendon, where retears are most common, were not tested.

Title: Shoulder scores over time - Description: ASES and Constant scores before and after surgery, with and without the patch, in the Ruiz Iban and Camacho Chacon trials

Figure 1. ASES and Constant scores over time, with and without the patch, in the two trials behind the AAOS strong recommendation. When the patch was added to a repair, the two groups tracked each other at every time point [12,13]. When the patch was used instead of a repair, the groups separated [14]. Ruiz Ibán values were read from the published figure; Camacho Chacón values are medians from the published tables.

The guideline lists the risks of these implants as longer operating time, possible infection and added cost. It does not mention stiffness or reoperation. It closes by calling for high-quality studies “to definitively establish the benefits of these devices” [11].

What else we know about patches

•    Partial-thickness tears. In a manufacturer-funded randomized trial of 41 patients, a patch without repair produced better WORC scores at 6 weeks and 3 months than takedown and repair. There was no difference in any patient-reported outcome at 6 or 12 months. The patch group was told to wear the sling for 1 week, the repair group for 4 to 6 weeks [15].

•    Meta-analysis. Improvement and the proportion of patients reaching the MCID after patch-augmented repair were similar to historical standard repair. The overall complication rate was 15.5% after full-thickness and 16.2% after partial-thickness repairs. There were no concurrent controls [16].

•    Matched cohort. At a minimum of 2 years, 47 patched repairs and 94 matched unpatched repairs had similar ASES (81 vs. 85), SSV (79 vs. 85) and pain scores. Reoperation for inflammation and stiffness was 9% (4/47) with the patch and 0% (0/94) without it. The authors stopped using the implant [17]. In the accompanying commentary, McAllister Nolan noted that these grafts are “heavily promoted to surgeons by industry” and recommended avoiding them for this indication [18].

•    Partial-thickness repairs. In a propensity-matched comparison, stiffness in the first 12 weeks occurred in 8 of 32 patched shoulders and 1 of 32 controls. Six patched shoulders, and no controls, required reoperation for stiffness [19]. This happened even though the controls more often had a tear takedown and repair (18 vs. 5 of 32), an operation that could be expected to cause more stiffness, not less [20].

•    Human dermal allograft in large tears. One randomized trial reports a longer follow-up. Sixty patients with 3 to 5 cm tears had repair with or without a human dermal allograft; 43 were seen at a mean of 5.7 years [21]. Retear was 9.1% with the allograft and 38.1% without it. The trial’s primary outcome, the Constant score, did not improve more with the allograft (p = 0.053). The ASES improved 13 points more with the allograft (p = 0.047), but the allograft group started 5 points lower [21]. This is a different product from the bovine implant in the AAOS strong recommendation, and the guideline rates the dermal allograft evidence as moderate [11].



A "strong" recommendation carries weight beyond the operating room [6]. A patient with a retear after an unpatched repair could point to it. A surgeon who left the patch out because the patient-reported data did not support it would have to defend that choice. Meanwhile the patient who receives a patch, becomes stiff and needs a second operation may ask why the implant was used. 

The cost is real. An economic analysis co-authored by an employee of the manufacturer assumed that the implant adds $3,641 to each repair; our meta-analysis cites $5,000 to $10,000 per case [6,22]. That analysis estimated an added $232,468 per 100 patients to obtain 18 more MRI-healed tendons [22]. That is a cost per healed tendon, not per patient with greater improvement.

A 2026 analysis, labeled "Level I evidence", concluded that the patch is “the dominant, cost-effective treatment strategy” over 10 years, saving money and adding 1.3 quality-adjusted life years per patient [23]. This is not an outcome study: no patient was followed for 10 years. It is a computer model, and its conclusion follows from its assumptions rather than from observed results. The study received grant funding from the manufacturer [23].

 

What the model assumed

What the trial on which it was based actually found [12,13]

New retears

Each year, 26% of intact unpatched repairs and 8% of intact patched repairs retear. Over 10 years, that adds up to about 95% of unpatched and 57% of patched repairs.

35% of unpatched and 12% of patched repairs had retorn at 2 years. But the retear rate drops off over the first year. Only about 9% more control repairs retore in the second year. In contrast to the assumption, the retear rate is no the same "each year".

Quality of life

Assigned from MRI status: 0.7 if intact, 0.6 if torn, values taken from an earlier publication.

Quality of life was measured directly (EQ-5D) and did not differ between groups at any time.

Reverse arthroplasty

Each year, 16% of patients with a retorn tendon go on to reverse arthroplasty, at about $34,500 each.

No patient had a reverse arthroplasty. Two had early reoperations, both in the control group, and none occurred in the second year.


Each assumption favors the patch. The model turns a modest difference in retears at 2 years into a large one at 10, gives that difference a quality-of-life cost the trial did not find, and converts it into expensive operations that did not occur. Even its own quality-of-life values cannot produce the reported gain: if every unpatched tendon were torn and every patched tendon intact for all 10 years, the difference would be less than 0.9 quality-adjusted life years, not 1.3.

Who pays also matters. In one ambulatory surgery center, use of a biologic (a dermal allograft or bioinductive implant) was the largest single driver of charges for cuff repair, adding $17,791 to a risk-adjusted $19,728 [24]. Ambulatory cuff repair is increasingly paid under fixed-rate, episode-based bundles, in which the surgeon and facility bear the financial risk of added costs [25]. When the payment for the repair is fixed, the patch comes out of the margin, and a surgeon who owns a share of the center faces a three-way pull. On one side are a strong guideline recommendation and its medicolegal weight; on another, the surgeon’s own finances; and in between, trials showing no difference that patients are likely to notice. Contracts that pay for implants separately, or consulting relationships with manufacturers, can tilt the balance the other way. None of these is a clinical reason to use a patch, or to withhold one.

Questions to ask of any patch study

Abstracts deserve particular care. Among 16 systematic reviews comparing patch-augmented with unaugmented repair, 13 (81.3%) had spin in the abstract [26]. Spin was not associated with funding (P = .36), but each methodological flaw on the AMSTAR-2 checklist was associated with 61% more types of spin [26]. One example: a 2024 meta-analysis of 5 randomized trials of dermal patches concluded in its abstract that patches “improve outcomes.” Its discussion acknowledges that the differences, 2.8 Constant points and 5.6 ASES points, did not reach the MCIDs of 4.6 and 11.1 [27].

When the results of a well-controlled study on the effectiveness of patches in cuff repair are presented, we should ask:

1.   What was the difference in patient-reported outcome between groups, and did it reach the MCID?

2.   What proportion of patients in each group reached the MCID or the patient acceptable symptom state?

3.   How many had stiffness, capsulitis or reoperation, compared with controls?

4.   Was the control a repair alone, something less (debridement), or something more (takedown and repair)?

5.   Were the rehabilitation protocols the same in both groups?

6.   Who paid for the study?

Bottom line

What is demonstrated: (1) a bovine patch placed over a sound repair lowers the MRI retear rate; (2) a patch used instead of a repair combined with faster rehabilitation may return some patients to daily activities sooner; and (3) patches are associated with more stiffness and reoperation in unconflicted series.

What is not demonstrated: that adding a patch improves comfort or function by an amount that is clinically significant. 

Most trials follow patients for only one to two years; the mean follow-up in our meta-analysis was 18 months [6]. Whether fewer retears translate into better function later, or into less cuff tear arthropathy, is not known. 


Considering..
The Northern Shrike
AKA the "Butcher Bird" because he hangs his catch on tree thorns.

The author of this post has no financial relationship with any orthopaedic company.


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References

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[3]        Kim YK, Kim YT, Won YS, et al. Efficacy of an autologous dermal fibroblast injection in reducing the retear rate after arthroscopic rotator cuff repair: a prospective randomized controlled trial. Am J Sports Med. 2025;53(3):592-9.

[4]        Ye Z, Chen C, Chen H, et al. Bone marrow stimulation yielded similar clinical outcomes with improved tendon healing and abduction strength compared with decortication for arthroscopic rotator cuff repair in shoulder active patients. Arthroscopy. 2025;41(8):2740-9.e3.

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[6]        Checketts JX, Daniels SD, Schiffman CJ, Matsen FA III, Hsu JE. Biologic augmentation improves rotator cuff integrity but not clinically significant patient outcomes: a meta-analysis of randomized controlled trials. JBJS Open Access. 2026;11:e26.00248. doi:10.2106/JBJS.OA.26.00248

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[10]      Amin V, Ghayyad K, Oshikoya O, Goltz D, Huffman GR. Biologic graft augmentation is associated with lower retear rates and greater tendon thickness compared with arthroscopic rotator cuff repair without augmentation: a systematic review and meta-analysis of randomized controlled trials. Arthroscopy. 2026. doi:10.1002/arj.70619

[11]      American Academy of Orthopaedic Surgeons. Management of Rotator Cuff Injuries: Evidence-Based Clinical Practice Guideline. Published August 18, 2025. https://www.aaos.org/rccpg2025

[12]      Ruiz Ibán MA, Garcia Navlet M, Moros Marco S, et al. Augmentation of a transosseous-equivalent repair in posterosuperior nonacute rotator cuff tears with a bioinductive collagen implant decreases the retear rate at 1 year: a randomized controlled trial. Arthroscopy. 2024;40(6):1760-73.

[13]      Ruiz Ibán MA, García Navlet M, Moros Marco S, et al. Augmentation of a posterosuperior cuff repair with a bovine bioinductive collagen implant shows a lower retear rate but similar outcomes compared with no augmentation: 2-year results of a randomized controlled trial. Arthroscopy. 2025;41(10):3869-79. doi:10.1016/j.arthro.2025.03.057

[14]      Camacho Chacón JA, Roda Rojo V, Martin Martinez A, et al. An isolated bioinductive repair vs sutured repair for full-thickness rotator cuff tears: 2-year results of a double blinded, randomized controlled trial. J Shoulder Elbow Surg. 2024;33(9):1894-904. doi:10.1016/j.jse.2024.03.043

[15]      Wang A, Breidahl W, Ek ET, et al. Early functional recovery is improved in patients treated with bioinductive collagen implant augmentation compared with standard arthroscopic repair of high-grade partial-thickness rotator cuff tears: a prospective randomized trial. Orthop J Sports Med. 2026;14(3):23259671261418675. doi:10.1177/23259671261418675

[16]      Warren JR, Domingo-Johnson ER, Sorensen AA, et al. Bioinductive patch as an augmentation for rotator cuff repair, a systematic review and meta-analysis. J Shoulder Elbow Surg. 2024;33(11):2515-29. doi:10.1016/j.jse.2024.05.002

[17]      Haft M, Li SS, Pearson ZC, et al. No short-term clinical benefit to bovine collagen implant augmentation in primary rotator cuff repair: a matched retrospective study. Clin Orthop Relat Res. 2025;483:442-52. doi:10.1097/CORR.0000000000003247

[18]      McAllister Nolan B. CORR Insights®: No short-term clinical benefit to bovine collagen implant augmentation in primary rotator cuff repair: a matched retrospective study. Clin Orthop Relat Res. 2025;483:453-4. doi:10.1097/CORR.0000000000003281

[19]      Yeazell S, Lutz A, Bohon H, et al. Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial. J Shoulder Elbow Surg. 2022;31(6 Suppl):S131-5. doi:10.1016/j.jse.2022.02.003

[20]      Yeazell S, Lutz A, Bohon H, et al. Response to Bushnell et al regarding: "Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial." J Shoulder Elbow Surg. 2022;31:e572-3. doi:10.1016/j.jse.2022.06.028

[21]      Lee GW, Kim JY, Lee HW, Yoon JH, Noh KC. Clinical and anatomical outcomes of arthroscopic repair of large rotator cuff tears with allograft patch augmentation: a prospective, single-blinded, randomized controlled trial with a long-term follow-up. Clin Orthop Surg. 2022;14(2):263-71. doi:10.4055/cios21135

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[23]      Hurley ET, Ruiz Ibán MÁ, Oeding JF, et al. Bio-inductive collagen implant augmentation for arthroscopic rotator cuff repair is cost-effective in medium to large tears for reducing retears: a secondary analysis of a randomized controlled trial. Arthroscopy. 2026;42:73-82. doi:10.1002/arj.70000

[24]      Morris JH, Malik AT, Hatef S, Neviaser AS, Bishop JY, Cvetanovich GL. Cost of arthroscopic rotator cuff repairs is primarily driven by procedure-level factors: a single-institution analysis of an ambulatory surgery center. Arthroscopy. 2021;37(4):1075-83. doi:10.1016/j.arthro.2020.11.033

[25]      Lu Y, Labott JR, Salmons HI IV, et al. Identifying modifiable and nonmodifiable cost drivers of ambulatory rotator cuff repair: a machine learning analysis. J Shoulder Elbow Surg. 2022;31:2262-73. doi:10.1016/j.jse.2022.04.008

[26]      Al-Badaineh M, Josan H, Imran B, et al. Spin in systematic reviews on patch-augmented rotator cuff repair: prevalence, predictors, and methodological implications. J Shoulder Elbow Surg. 2026 [Epub ahead of print]. doi:10.1016/j.jse.2026.07.030

[27]      Hurley ET, Crook BS, Danilkowicz RM, et al. Acellular collagen matrix patch augmentation of arthroscopic rotator cuff repair reduces re-tear rates: a meta-analysis of randomized control trials. Arthroscopy. 2024;40(3):941-6. doi:10.1016/j.arthro.2023.09.025