Rethinking rotator cuff tear management - how do we want to spend the money?

The management of patients with rotator cuff tears presents a significant clinical and economic challenge. With annual costs of rotator cuff surgery exceeding $3 billion in the United States alone, and increasing evidence that structural repair does not always correlate with functional outcomes, a critical reassessment of the cost-effectiveness of different management options seems warranted. 

Let's start with a case example

A 70 year old active skier, cyclist, climber and practicing orthopaedic surgeon presented with the progressive onset of pain in the right shoulder. Physical examination revealed weakness of resisted elevation, but a good range of active motion. Plain radiographs showed no evidence of arthritis. The MRI findings are shown below.  

Surgical repair was offered but declined in favor of a home exercise program. A decade later the shoulder has a full painless range of range of motion and strength sufficient for sports and surgical practice. 

An Overview

Prevalence, Natural History, and Nonoperative Treatment of Rotator Cuff Disease

Rotator cuff disease is extremely common, affecting up to 25% of the population over age 40. Tear prevalence, size, likelihood of progression, and retear rates after surgical repair are all related to increasing age. Fewer than 5% of people with rotator cuff tears come to surgery, the great majority of rotator cuff tears are either asymptomatic or mildly symptomatic. 

However, Over a half million cuff surgeries are performed each year and this number is increasing

Non-operative treatment represents the most cost-effective strategy for many patients with symptomatic rotator cuff tears.

Jed Kuhn and the MOON (Multicenter Orthopaedic Outcomes Network) Shoulder Group that he leads published Effectiveness of physical therapy in treating atraumatic full-thickness rotator cuff tears: a multicenter prospective cohort study, a multicenter prospective cohort study of 452 patients with atraumatic full-thickness rotator cuff tears treated with a standardized physical therapy protocol. The study found that 75% of patients achieved successful outcomes with physical therapy alone at 2-year follow-up, with "failure" defined as patients electing to undergo surgery. 

The Predictors of Surgery for Symptomatic, Atraumatic Full-Thickness Rotator Cuff Tears Change Over Time: Ten-Year Outcomes of the MOON Shoulder Prospective Cohort, a follow-up study tracked the original cohort for 10 years and found that physical therapy remained successful in over 70% of patients, with only 27% ultimately requiring surgery. Importantly, patient-reported outcomes improved with physical therapy and did not decline over the 10-year period. This study won the 2024 Kappa Delta Ann Doner Vaughan Award and demonstrated the long-term durability of non-operative treatment.

EXERCISE THERAPY IN THE NON-OPERATIVE TREATMENT OF FULL-THICKNESS ROTATOR CUFF TEARS: A SYSTEMATIC REVIEW Of the non-operatively treated cohorts 78% improved in pain, 81% improved in range of motion, 85% improved in strength, 84% improved in functional outcomes. Dissatisfied outcomes occurred in 15% of patients, who then transitioned to surgery.

The cost differential is substantial. Home exercises are inexpensive and often effective. While comprehensive physical therapy may cost $1,500-3,000 over several months, surgical repair typically ranges from $15,000-25,000, creating a 10-fold cost difference for initial treatment. Given that many patients achieve acceptable outcomes with therapy alone, this represents a significant opportunity for cost savings without compromising patient outcomes.

Patient selection for non-operative management should prioritize older individuals (typically >65 years), those with maintained active forward elevation without pseudoparalysis, reasonable functional demands, and chronic rather than acute tears. 

Symptoms of cuff tears do not correlate strongly with the magnitude of the defect.

Symptoms of pain do not correlate with rotator cuff tear severity: a cross-sectional study of 393 patients with a symptomatic atraumatic full-thickness rotator cuff tear, A cross-sectional study of 393 patients with symptomatic atraumatic full-thickness rotator cuff tears demonstrated that pain severity does not correlate with tear size or other anatomic features. This finding challenged the assumption that larger tears necessarily cause more symptoms and require more aggressive treatment.

Patient self-assessed shoulder comfort and function and active motion are not closely related to surgically documented rotator cuff tear integrity found that cuff integrity was not strongly associated with the shoulder's comfort or function. 

Repair attempts often lead to failure of anatomic healing of the tendon to bone; clinical outcomes are largely independent of repair integrity.

Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? Only 43% of patients over the age of sixty-five years had completely healed tendons.

Failure with continuity in rotator cuff repair "healing" found that all rotator cuff repairs retracted substantially away from their position of initial fixation during the first year after surgery (mean 16.1 ± 5.3 mm; range, 5.7-23.2 mm), yet only 30% of patients showed a defect on MRI. This study is important because it indicates that an "intact" tendon repair on MRI may not indicate healing of the tendon to the insertion site. This finding may be especially relevant to the assessment of repair integrity after the use of patches and grafts.

The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears reported arthroscopic repair of large and massive rotator cuff tears led to a high percentage of recurrent defects. The minimum twelve-month evaluation showed excellent pain relief and improvement in the ability to perform activities of daily living despite the high rate of recurrent defects.

Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome found that the mean re-tear rate was 26.6% at a mean of 23.7 months after surgery.  Patient-reported outcomes were generally improved whether or not the repair restored the integrity of the rotator cuff.  In spite of a dramatic increase in the number of publications per year and the advent of biologic augmentation there was little evidence that the clinical results of rotator cuff repair were improving with time. 

Structural Integrity After Rotator Cuff Repair Does Not Correlate with Patient Function and Pain The differences in validated functional outcome scores and pain were not clinically significant for intact and failed repairs.

Non-repair surgery - the underutilized "smooth and move" procedure / debridement (see this link)

Smoothing the humeroscapular motion interface without acromioplasty is a quick, safe procedure for painful cuff tears in shoulders with preserved active elevation. It allows the patient immediate return to use of the shoulder without postoperative "down time". It does not involve use of a more costly "subacromial balloon" or a "biological tuberoplasty". The cost-effectiveness advantages of debridement are substantial. Operative time is typically 30-45 minutes compared to 2-3 hours for complex repairs, resulting in lower facility and anesthesia costs. Recovery is faster, allowing quicker return to activities and reduced rehabilitation expenses. Complication rates are lower due to the less invasive nature of the procedure.

Treatment of irreparable cuff tears with smoothing of the humeroscapular motion interface without acromioplasty.  In 77 shoulders with previously unrepaired irreparable tears, simple shoulder test (SST) scores improved from an average of 4.6 to 8.5. Fifty-four patients (70%) improved by at least the minimally clinically important difference (MCID) of 2 SST points. For 74 shoulders with irreparable failed prior repairs, SST scores improved from 4.0 to 7.5. Fifty-four patients (73%) improved by the MCID. This conservative procedure offers an alternative to more complex procedures in the management of irreparable rotator cuff tears.

Significant improvement in patient self-assessed comfort and function at six weeks after the smooth and move procedure for shoulders with irreparable rotator cuff tears and retained active elevation In 40 patients with preoperative and 6-week postoperative measurements, the Simple Shoulder Test scores improved from an average of 3.4 ± 2.8 preoperatively to 5.7 ± 3.5 at 6 weeks (p < 0.001), an improvement that exceeded the published values for the minimal clinically important difference (MCID). The clinical outcomes were not worse for the 18 shoulders with irreparable tears of both the supraspinatus and infraspinatus. In addition to its previously documented long-term effectiveness for shoulders with irreparable rotator cuff tears and retained active elevation, this study demonstrates that the smooth and move procedure provides clinically significant improvement as early as 6 weeks after surgery.

Comparing outcomes between debridement and attempted repair of large/massive tears reveals only modest functional differences, yet the repair costs more and carries higher complication risks.

Massive rotator cuff tears: functional outcome after debridement or arthroscopic partial repair Both treatment groups had similar pain relief and satisfaction, reflected in equal values of disabilities of the arm, shoulder and hand (DASH) score. Ultrasonography revealed structural failure of the partial rotator cuff repair in 52% at final follow-up.

Partial rotator cuff repair versus debridement for irreparable rotator cuff tears: A systematic review 709 shoulders from 706 patients were reviewed, with 380 patients receiving a partial repair and 329 shoulders receiving debridement.  Pre- and post-operative mean VAS scores were the same for both treatments. Patient satisfaction with partial repair was reported as 75 %; for patients treated with debridement, post-operative satisfaction was 80.7 %.This systematic review study demonstrates that both partial repair and debridement alone can result in acceptable clinical outcomes with no significant differences noted for patients with irreparable rotator cuff tears in short to mid-term follow up.

Standard Rotator Cuff Repair

Standard surgical repair remains the gold standard of treatment for cuff tears when the quantity and quality of the tendon is adequate. The outcomes of cuff repair surgery are strongly influenced by the patient's nutrition. See: The "Secret Sauce" for Optimizing Rotator Cuff Outcomes: Biologics or nutrition?

Biologics, patches, PRP, and augmentation 

While these interventions are associated with reduced retear rates there is currently insufficient evidence that their significantly increased costs result in clinically meaningful improvement in clinical outcomes for patients. Structural healing on imaging does not reliably translate to better clinical outcomes for patients. This disconnect persists despite 25+ years of rotator cuff biological augmentation research.

Platelet-Rich Plasma (PRP)

Use of platelet-rich plasma for the improvement of pain and function in rotator cuff tears: a systematic review and meta-analysis with bias assessment Improvements in PRP-treated patients were noted for multiple functional outcomes, but none reached their respective minimal clinically important differences

Clinical and structural outcomes after arthroscopic repair of full-thickness rotator cuff tears with and without platelet-rich product supplementation: a meta-analysis and meta-regression. A meta-analysis of Level I and II studies found no statistically significant differences in overall outcome scores or retear rates between PRP-treated and control groups.

Evaluating the longitudinal efficacy of platelet-rich plasma in rotator cuff surgery: a systematic review and meta-analysis While PRP reduced pain (VAS) in the early postoperative period, the improvement was not clinically significant.

Platelet-rich plasma for arthroscopic repair of large to massive rotator cuff tears: a randomized, single-blind, parallel-group trial found that despite better structural healing in the PRP group, there was no clinically significant difference in outcomes between groups.

Cost: Approximate per-procedure expense of PRP:  preparation kits: $600 per case; 15 min additional OR time for preparation ($600), processing equipment ($3,000-15,000). The Cost-Effectiveness of Using Platelet-Rich Plasma During Rotator Cuff Repair: A Markov Model Analysis This cost-utility analysis shows that, currently, the use of PRP to augment rotator cuff repair is not cost-effective.

Scaffold and Patch Augmentation

The clinical adoption of these technologies raises questions about their actual effectiveness in improving patient outcomes, their cost-effectiveness in real-world practice, and their safety profile. 

A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair found the change in ASES, Constant, and UCLA scores were not clinically signficantly better (did not exceed MCID) for the matrix augmentation group than for the controls.

A pilot randomised controlled trial assessing standard versus dermal patch-augmented rotator cuff repair found no adverse effects and suggest future trials need a minimum of 150 patient Among 40 patients randomized to augmented repair versus standard repair there was no difference between groups with respect to clinical outcomes.

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 This prospective, single-blinded RCT compared arthroscopic repair of large rotator cuff tears with vs. without allograft dermal patch augmentation at mean 7.3-year follow-up. Clinical outcomes (Patch vs. Control at final follow-up): VAS pain: 1.3 vs. 1.5 (difference 0.2 - clinically insignificant) ASES: 87.9 vs. 86.1 (difference 1.8 points - well below MCID of 6.4) Constant: 82.6 vs. 79.5 (difference 3.1 points - well below MCID of 10.4)UCLA: 32.0 vs. 31.0 (difference 1.0 point - below MCID) SST: 10.2 vs. 9.6 (difference 0.6 - below MCID of ~2 points). None of these differences were clinically significant.

Outcome of Large to Massive Rotator Cuff Tears Repaired With and Without Extracellular Matrix Augmentation: A Prospective Comparative Study Uniquely, this study showed a clinically significant difference in ASES score with matrix augmentation.

Cost: Resorbable Bioinductive Collagen Implant Is Cost Effective in the Treatment of Rotator Cuff Tears Average cost of treatment $32,213 without Regeneten, $54,459 with Regeneten (additional cost 69%). The authors did not assess patient reported outcomes or revision rates for patients without or with the patch. While using "healing" as the study endpoint, the authors point out that there is lack of agreement on what constitutes healing or re-tearing after a cuff repair based on magnetic resonance imaging, ultrasound, or arthrogram. Evidence was not presented that "healing" by imaging correlated with better clinical outcomes .

Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy. Average cost of treatment €4650 without Regeneten, €7828 with Regeneten (additional cost 68%). Study limitations the same as those for the report above.

Complications: 

Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial found that postoperative stiffness was observed in the first 12 weeks in 8 of 32 patients in the Regeneten patch group compared with 1 of 32 patients in the control group. Six patients in the patch group underwent reoperations compared with no patients in the control group. All 6 reoperations in the patch group were performed to address stiffness. The authors concluded that patients in the patch group had a significantly higher rate of postoperative stiffness. In the majority of patients in whom shoulder stiffness developed, reoperation was required. 

Subacromial-Subdeltoid Bursitis With Rice Bodies After Rotator Cuff Repair With a Collagen Scaffold Implant: A Case Report. reported a case of subacromial-subdeltoid bursitis with rice bodies after rotator cuff repair with a Smith + Nephew REGENETEN bovine-derived bioinductive collagen scaffold implant. After debridement, the patient recovered well and made a full return to work and recreational activities.

Revision arthroscopic surgery after rotator cuff repair with a collagen graft: histologic evaluation of biopsy specimens from two patients. Patients undergoing collagen scaffold augmentation should be warned of the possibility of reactive bursitis. Cases of reactive bursitis may need to be managed with surgical débridement to treat symptoms and structural failure and to rule out infection. 

Restore orthobiologic implant: not recommended for augmentation of rotator cuff repairs  Years after surgical repair of large rotator cuff defects supplemented with a xenograft, patients had persisting deficits and no recognizable benefit as compared with the results in a control group. In view of these findings, together with the unsatisfactorily high proportion of patients with a severe inflammatory reaction to the xenograft, the authors do not recommend use of the Restore Orthobiologic Implant.

Subacromial-Subdeltoid Bursitis With Rice Bodies After Rotator Cuff Repair With a Collagen Scaffold Implant: A Case Report This case demonstrates persistent pain, swelling and decreased range of motion for several months after rotator cuff repair with the use of a collagen implant

Severe subacromial-subdeltoid inflammation with rice bodies associated with implantation of a bio-inductive collagen scaffold afterrotator cuff repair  The potential for an acute, significant painful phase in a patient’s recovery should be part of the informed-consent process when using the Regeneten implant.

These findings suggest that reactive bursitis may be an under-recognized complication of biological patch augmentation, potentially contributing to the increased stiffness rates observed in larger series. What makes these complication rates concerning is their infrequency in control groups. In the propensity-matched study, zero patients in the standard repair group required reoperation, while 19% of patch-augmented patients did experience this novel category of complications associated with the augmentation material itself.

Conclusions:

(1) Age-relared rotator cuff failure is common and very often minimally symptomatic.

(2) Physical therapy can be cost-effective in improving comfort and function for the majority of patients with these tears.

(3) Non-repair surgery (smooth and move/debridement) can be cost-effective for patients with retained active elevation

(4) Surgical repair can be cost-effective when there is adequate quantity and quality of cuff tendon.

(5) PRP and "biologic" patches have not been shown to be cost-effective in improving patient reported outcomes. Sponsored 'cost-effectiveness' studies measuring surrogate endpoints (e.g. healing by imaging) rather than patient-centered outcomes may be misleading by not considering patient outcomes and complications.

Looking the problem in the eye.

Red-faced Warbler

Tucson

Spring 2020

Follow on twitter/X: https://x.com/RickMatsen
Follow on facebook: https://www.facebook.com/shoulder.arthritis
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Here are some videos that are of shoulder interest
Shoulder arthritis - what you need to know (see this link).
How to x-ray the shoulder (see this link).
The ream and run procedure (see this link)
The total shoulder arthroplasty (see this link)
The cuff tear arthropathy arthroplasty (see this link).
The reverse total shoulder arthroplasty (see this link).
The smooth and move procedure for irreparable rotator cuff tears (see this link)

Shoulder rehabilitation exercises (see this link). 

Rotator cuff tears and tendinopathy - Is platelet rich plasma (PRP) helpful? Read this important updated version.

A review of published randomized trials and meta-analyses indicates that non-operative treatment is effective for the majority of patients with conditions of the rotator cuff, including rotator cuff tears.

Local corticosteroid injections are sometimes used in non-operative treatment, however they apparently have no biologic effect in terms of regenerating or reversing the degenerative changes occurring in rotator cuff tendons and their clinical benefit usually wears off quickly.

It has been suggested that local injection of platelet-rich plasma (PRP) may promote stem and progenitor cell proliferation, modulate inflammatory responses, stimulate angiogenesis, enhance the proliferation of tenocytes, stimulate the production of extracellular matrix proteins, protect against oxidative stress, and inhibit inflammation (see Platelet-Rich Plasma in Orthopaedic Surgery: A Critical Analysis Review) and that these effects may benefit patients with rotator cuff tendinopathies before structural failure of the rotator cuff occurs. 

 The authors of Subacromial injection of platelet-rich plasma provides greater improvement in pain and functional outcomes compared to corticosteroids at 1-year follow-up: a double-blinded randomized controlled trial attempted to answer this question in a randomized clinical trial of patients between 18 and 50 years old (mean age 28 years) who had both a clinical and magnetic resonance imaging diagnosis of supraspinatus tendinopathy refractory to conservative treatment. 

A total of 50 patients received a single subacromial injection of PRP, whereas 50 patients received a single subacromial corticosteroid injection. All the patients completed 12 months of clinical follow-up. 

At 12 months, in comparison to the those receiving cortisone, patients in the PRP group showed a significantly greater improvement in 

the VAS score: 1.68 vs. 2.3

the American Shoulder and Elbow Surgeons (ASES) score, 89.8  vs. 78.0 

the Single Assessment Numeric Evaluation (SANE) score, 89.2 vs. 80.5 

and the the Pittsburgh Sleep Quality Index (PSQI) score, 2.72 vs. 4.02 

The overall failure rate was significantly higher in the corticosteroid group (30%) than in the PRP group (12%) (P < .01).

It was particularly interesting to note that the difference in the course of the two groups was not evident until 6 months after the injection. As Michael Pearl pointed out, it is possible that the PRP folks would have gotten better anyway (i.e. the PRP may not have had an effect). We'd need a saline injected control arm to examine that possibility.

It does seem that the corticosteroid injected group tended to do less well with time and their greater failure rate may be related to the adverse effects of cortisone on tendons. As Dr Pearl says "An alternative explanation could be that cortisone is deleterious and the PRP less interfered with the natural history.  " 

It is notable that the ASES score difference between 3 and 12 months (85 to 90) does not exceed the minimal clinically important difference for ASES of 15. 

Comment: This double blinded randomized clinical trial showed that young patients with rotator cuff tendinosis having subacromial injection of PRP did better than comparable patients having subacromial injection of cortisone. It does not show that patients having subacromial injection of PRP would do better than those with no treatment or with a placebo control. Keep in mind that these patients had an average age of 28, folks who have a lot of potential for recovery with time and rehab.

A possible benefit of PRP in cuff tendinosis cannot be extrapolated to the treatment of cuff tendons with structural failure, as demonstrated by the authors of Subacromial Platelet-Rich Plasma Injections Produce Significantly Worse Improvement in Functional Outcomes in Patients With Partial Supraspinatus Tears Than in Patients With Isolated Tendinopathy who found that  improvement in the ASES score was significantly greater in the group without tears than in the group with partial cuff tears (PTRCTs) at all follow-up times. 94% of the patients in the isolated tendinopathy group but less than half of patients in the PTRCTs group achieved a substantial clinical benefit at 12 months follow-up. 

Furthermore, a review of published randomized controlled trials and meta-analyses failed to demonstrate a clinically significant benefit to the patient of the use of PRP in conjunction with surgical repair of a torn rotator cuff.

You can support cutting edge shoulder research that is leading to better care for patients with shoulder problems, click on this link

Follow on twitter/X: https://x.com/RickMatsen

Follow on facebook: https://www.facebook.com/shoulder.arthritis

Follow on LinkedIn: https://www.linkedin.com/in/rick-matsen-88b1a8133/

Here are some videos that are of shoulder interest
Shoulder arthritis - what you need to know (see this link).
How to x-ray the shoulder (see this link).
The ream and run procedure (see this link).
The total shoulder arthroplasty (see this link).
The cuff tear arthropathy arthroplasty (see this link).
The reverse total shoulder arthroplasty (see this link).
The smooth and move procedure for irreparable rotator cuff tears (see this link).
Shoulder rehabilitation exercises (see this link). 

PRP for Cuff Disease: Data Fragility of a Level I Study

Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease A Randomized Controlled Trial

These authors investigated the safety and efficacy of a fully characterized allogeneic pure PRP injection into the subacromial space of patients with "rotator cuff disease" in comparison with corticosteroid injection. Inclusion criteria: ≥18 years ofd age, unilateral shoulder pain for at least 3 months, a Neer or Hawkins impingement sign,  either a painful arc or a positive result on the Jobe test. Exclusion criteria included previous subacromial injections within the past 3 months, a history of shoulder trauma, a full-thickness rotator cuff tear as demonstrated with magnetic resonance imaging (MRI) or ultrasonography, and limitation of both active and passive movement of the glenohumeral joint of 25% in at least 2 directions as compared with the contralateral shoulder or with normal values.

60 patients with rotator cuff disease were randomly assigned to receive a subacromial injection of either 4 mL of allogeneic pure PRP or a 4-mL mixture of 1 mL of 40-mg/mL triamcinolone acetonide and 3 mL of 2% lidocaine under ultrasonographic guidance. 

The authors concluded that " Constant score at 1 month did not significantly differ between the PRP and corticosteroid groups. At 6 months, the DASH (Disabilities of the Arm, Shoulder and Hand) score, overall function, and external rotation were significantly better in the PRP group than in the corticosteroid group, and the other clinical outcomes did not show significant differences. All pain measurements, the strength of the supraspinatus and infraspinatus, and 5 functional scores also improved slowly and steadily after injection, becoming significantly better at 6 months compared with those before the injection, whereas those in the corticosteroid group responded promptly but did not further improve. Allogeneic PRP injections for the treatment of rotator cuff disease are safe but are not definitely superior to corticosteroid injections with respect to pain relief and functional improvement during 6 months. The DASH score, overall function, and external rotation were significantly better in the PRP group than in the steroid group at 6 months. Generally, PRP slowly but steadily reduced pain and improved function of the shoulder until 6 months, whereas corticosteroid did not."

Comment: Let's take a look at the DASH data. Recalling that a lower DASH score is good, we can see that at later time points the average DASH scores for the available patients are lower (i.e. better).

A few blog posts ago we discussed data fragility (see this link). Fragility is an indication of how sensitive the result is to the loss of patients to followup. 

In this study, we see that the average DASH score for the patients available at each time point after treatment is related to the percentage of patients lost to followup. The best (lowest) DASH score is at 6 months when 24% of the original patients were not included. The conclusion that the DASH improved with time is fragile because it is possible that the missing 24% could have had higher (worse) DASH scores at 6 months - we just don't know. 

It is also of interest that the percent of patients lost to followup (especially at 6 months) is quite different for the PRR and the steroid groups as shown below.

This limitation is not discussed in the limitations discussion of the paper.

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How you can support research in shoulder surgery Click on this link.

We have a new set of shoulder youtubes about the shoulder, check them out at this link.

Be sure to visit "Ream and Run - the state of the art" regarding this radically conservative approach to shoulder arthritis at this link and this link

Use the "Search" box to the right to find other topics of interest to you.

You may be interested in some of our most visited web pages  arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

 

‘‘Stem Cell Treatments Flourish With Little Evidence That They Work’’

This was a headline in the May 13, 2019 New York Times. You must read the full article in this link.

Here is a nice review: The role of biologic agents in the management of common shoulder pathologies: current state and future directions
Here are their conclusions regarding platelet rich plasma (PRP). Given the wide variety of clinical results for PRP injections for various shoulder pathologies, expectations must be tempered by clinicians and patients. Although basic science literature supports a potential role in the management of rotator cuff tears, robust clinical data are lacking to support their widespread use.

Here are their conclusions regarding "stem cells" or "cell based therapy" or Bone marrow aspirate concentrate (BMAC). BMAC has the unique advantage of containing a very small population of mesenchymal stem cells and a high proportion of various growth factors, but its true clinical efficacy is still largely unknown. High-quality studies with appropriate control groups are needed to better define its clinical role. A critical deficiency in the current literature is the lack of information correlating the composition and/or biologic activity of marrow-derived cells and clinical outcomes. Furthermore, obtaining BMAC is an expensive procedure with unknown cost-effectiveness.

One of the key issues is the direct to consumer advertising of stem cell and related therapies See this link.

Comment: Currently we are seeing aggressive marketing and patient demand that has led to the indiscriminate use of cell therapy for a wide range of musculoskeletal conditions. It is of note that in many cases the high cost of these procedures is covered by the patient because insurance companies have not been convinced of their effectiveness. Because of the lack of data on their value to the patient, we avoid these interventions in our patients.

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To see our new series of youtube videos on important shoulder surgeries and how they are done, click here.

Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages  arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

Are PRP, stem cells, or biomaterials of value in rotator cuff repair?

Biologics for Rotator Cuff Repair A Critical Analysis Review

In their introduction, the authors state that "Despite an increase in the number of operations performed and enhanced surgical techniques, unacceptably high rates of failure of up to 94% still occur." They point out that this has driven intense scientific and commercial interest in "biologics" (platelet-rich plasma, stem cells, and biomaterials) as a possible means for enhancing the healing of attempted cuff repairs.

In their review, these authors note that

(1) among the many types of biologic augmentation, there is considerable heterogeneity of the content, quality, and quantity of growth factors used in platelet-rich plasma and bone marrow aspirate concentrate, and conclusions from individual studies may not necessarily be generalizable to other formulations within the group.

(2) current Level-I evidence suggests that universal use of platelet-rich plasma provides no significant clinical benefit in rotator cuff repair.
(3) although some evidence exists for the use of stem cells from bone marrow aspirate concentrate and the use of biologic grafts, results from Level-I studies are lacking and 

(4) level-I trials focused on the evaluation of clinical outcomes (i.e. using the Simple Shoulder Test, the American Shoulder and Elbow Surgeons score, the University of California at Los Angeles  shoulder score, or the Constant score) should be performed to help to determine the appropriate use of biologic augmentation in rotator cuff surgical procedures.

Comment: As these authors indicate, all of the scientific and commercial interest in biologics needs to be evaluated in terms of well controlled studies showing that clinical outcomes are better for patients receiving biologics in comparison to comparable patients not receiving them. These studies need to be carried out in recognition of the observation that over 10 million individuals are living with cuff tears and at most 4% of them get surgery each year. It is commonly observed that patients with cuff tears can respond to physical therapy. Furthermore, patients are commonly clinically improved after cuff repair surgery whether or not the surgery is successful in restoring the integrity of the cuff. From a clinical standpoint, therefore, biologics are going to need to make a big difference in order to justify their cost.

For a perspective on cuff repair as well as a Robert Frost poem, readers are invited to visit this post:

Rotator cuff repair - failure with continuity

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We have a new set of shoulder youtubes about the shoulder, check them out at this link.

Be sure to visit "Ream and Run - the state of the art"  regarding this radically conservative approach to shoulder arthritis at this link and this link

Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages   arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

Does PRP help patients having rotator cuff repair?

Platelet-rich plasma in fibrin matrix to augment rotator cuff repair: a prospective, single-blinded, randomized study with 2-year follow-up

These authors point out that "despite improvements in the mechanical constructs used to repair rotator cuff tears, retear remains a significant issue. Retear rates ranging from 10%-90% depending on the size of the tear, age of the patient, amount of fatty infiltration, and type of repair have been reported. Higher failure rates in patients older than 65 years have been consistently demonstrated".

They sought to test the concept that application of autologous platelet-rich plasma in fibrin matrix (PRPFM) improves clinical outcomes in patients undergoing arthroscopic rotator cuff repair using a prospective, randomized, single-blinded study of 76 patients. The treatment group underwent arthroscopic rotator cuff repair with PRPFM. 

The control group did not receive the PRPFM. 

The Simple Shoulder Test scores showed no incremental benefit of PPFM: the improvement was from 45% to 96% for the control group and from 49% to 96% in the PRPFM group. 

Strength of the supraspinatus at 24 months by dynamometer testing was 99.8% in the control group and 96.3% in the PRPFM group. Infraspinatus strength was 104% in the control group and 103% in the PRPFM group

MRI's suggested a 19% retear rate for the control group and 7.4% for the PRPFM technique at 6 months.

All of their results showed no statistically significant benefit of PRPFM.

Comment: This is a valuable randomized trial that shows that showed no evidence of added clinical benefit for the PRPFM. If the study had not included the control group, one might conclude that cuff repair with PRPFM argumentation was a "clinically viable technique" because the patients were improved. However, with the inclusion of the control group, it became evident that the addition of PRPFM did not benefit the patients.

It is of interest that in spite of the apparently greater rate of retears in the control group, there was no difference in clinical outcomes.

The authors do not provide the incremental time involvement and the incremental cost of the PRPFM approach (see the details at the end of this post below).

In any event, evidence of incremental value for PRPFM was lacking.

Preparation of PRPFM: "Eighteen milliliters of whole blood was drawn from patients by use of sterile technique, transferred to a specially designed tube for centrifugation in a Drucker 755VES general-purpose centrifuge,

and spun for 6 minutes at 1100 RPM. During centrifugation, the heavier red and white blood cellular components moved to the bottom of the tube while the lighter platelets remained at the top in the plasma. A polyester separator gel in the tube sealed the red blood cells and the white blood cells to prevent contamination with the platelets. After processing, 4-4.5 cm3 of leukocyte-poor PRP was transferred to 2 separate tubes containing trace amounts of calcium chloride to replace the calcium that was bound by the citrate and was spun for an additional 15 minutes at 1450 RPM. This second, faster spin using the same centrifuge caused the fibrinogen in the plasma to form a 2-cm3 solid PRPFM in disk-like form. The PRPFM was then removed and fashioned on the back table to fit the size and shape of the tear.


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