Massive rotator cuff tears

The authors of Clinical outcomes of reverse shoulder arthroplasty and rotator cuff repair in patients with massive rotator cuff tears without osteoarthritis: comparison using propensity score matching defined massive rotator cuff tears (MRCTs) as those with tendon defects greater than 5 cm or those with 2 complete tendon tears on preoperative magnetic resonance imaging (MRI). They studied patients with MRCT without significant osteoarthritis, i.e. those with Hamada grades 1,2 or 3.

They compared and contrasted those patients that the senior author chose to treat by attempting rotator cuff repair and those he elected to treat with reverse shoulder arthroplasty (RSA) based on his assessment of factors such as age, sex, tear size and fatty infiltration of the cuff muscles. 

The retrospective data analysis found 68 patients treated for MRCTs via RSA and 215 patients treated for MRCTs via arthroscopic RCR. As can be seen from the table below, the patients chosen for RSA were different than those chosen for RCR.

The authors then used propensity score matching for sex, age, tear size, and global fatty degeneration index to reduce the initial cohort of 283 patients to 78 (28%): 39 in each treatment group. 

By comparing tables I and III one can see that 43% of the RSAs and 82% were eliminated by the matching, and that while "matched" with each other are not representative of the original cohorts with respect to age, sex, and tear size.

For the 39 reverses the Biomet Comprehensive (n=33), the Biomet Comprehensive Nano Stemless Shoulder (n=3), and the Exactech Equinox Reverse Shoulder (n=3) were used.

For the 39 cuff repairs a substantial number of ancillary procedures were performed.

While the included patients with massive cuff tears had preoperative pain (byVAS scale) and loss of function (by the Simple Shoulder Test), they had very good average active elevation as shown in the table below. This is consistent with the findings presented in the previous post (see this link), that patients with two-tendon rotator cuff tears can have preserved active elevation. The table below shows similarity in the postoperative results for matched patients from the two treatment groups.

 

Of interest is the observation that the anatomic success of the rotator cuff repair surgery did not have a statistically significant effect on the clinical outcome of the procedure (see Failure of healing of cuff repair and its effect on the clinical outcome).

 

Comment: As surgeons, we are not treating massive rotator cuff tears, we are treating patients with massive cuff tears. In that regard, the patient's preoperative active range of motion may carry more weight in the choice of treatment than the size of the tear. A reverse total shoulder may be "overkill" for the patient with a massive cuff tear, no arthritis and active elevation of 135 degrees of active elevation (see table IV second column). Many massive cuff tears cannot be durable repaired because of severe retraction and muscle/tendon degeneration. In those patients with irreparable massive cuff tears and retained active elevation, a simple "smooth and move" procedure (see this link) may restore comfort and function without the down time and risks associated with more complex surgical procedures.

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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).

30% Poor Outcomes After Reverse Shoulder Arthroplasty for Massive Rotator Cuff Tears Without Arthritis

The SANE score is the response to a single question: "How would you rate your affected shoulder as a percentage of normal (0% to 100% scale with 100% being normal)?” By contrast the Simple Shoulder Test (SST) and American Shoulder and Elbow (ASES) scores are based on the answers to multiple questions about shoulder pain and comfort.

The authors of Preoperative Single Assessment Numeric Evaluation Score Predicts Poor Outcomes After Reverse Shoulder Arthroplasty for Massive Rotator Cuff Tears Without Arthritis conducted a retrospective case-control study of factors predictive of poor outcomes after reverse shoulder arthroplasty performed by fellowship trained surgeons for 60 patients (mean age, 71.4±7.4 years) with massive rotator cuff tears without glenohumeral arthritis (Hamada score ≤3) having a minimum of 2 years of follow-up. Of these, 18 (30%) patients had poor outcomes as defined by one of more of the following:

ASES score of less than 50 

change in ASES score of less than 12

change in SST score of 1 or less

change in SANE score of less than 29

postoperative active forward elevation of less than 90°

revision surgery.

There was no obvious reason (eg, infection, dislocation, nerve injury) for poor outcomes.

The characteristic and outcomes for the controls (good outcomes) and cases (poor outcomes) are shown below 

This study found that higher preoperative SANE scores - but not the preoperative ASES and SST scores - were associated with a greater likelihood of poor outcome after RSA for massive rotator cuff tears.

As seen in the chart below, the preperative ASES and SST scores were the same for the control and case groups, whereas the preoperative SANE scores were higher for the case group than the control group. Thus the preoperative SANE scores did not correlate with the preoperative SST and ASES scores. This finding is unexplained in that the authors of Can the Single Assessment Numeric Evaluation (SANE) be used as a stand-alone outcome instrument in patients undergoing total shoulder arthroplasty? found that the correlation was excellent for the SANE score and the ASES score (n = 1447, r = 0.82, P < .0001), and the SST score (n = 1095, r = 0.81, P < .0001).

Comment: It is of interest that by the standards used in this study, almost 1/3 of patients with massive cuff tears without arthritis experienced a poor outcome after reverse total shoulder. Further clinical research is needed to establish the patients likely to experience poor outcomes so that alternate methods of management can be considered.

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

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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).

Massive irreparable rotator cuff tears without arthritis - 30% had poor outcomes with reverse total shoulder

Preoperative Single Assessment Numeric Evaluation Score Predicts Poor Outcomes After Reverse Shoulder Arthroplasty for Massive Rotator Cuff Tears Without Arthritis 

These authors conducted a retrospective case-control study for 60 patients (mean age, 71.4±7.4 years) who underwent reverse total shoulder (RSA) for massive rotator cuff tear without glenohumeral arthritis (Hamada score ≤3) and had a minimum of 2 years of follow-up. 

Criteria for a poor outcome included post op ASES score <50, change in ASES score <12, change in SANE score ≤ 29, change in Simple Shoulder Test Score ≤ 1, revision surgery and active forward elevation < 90. 

18 of these 60 patients (30%) met the criteria for a poor outcome (see "cases" below).

Patients with poor outcomes had significantly higher preoperative SANE scores compared with control subjects (40.4±28.4 vs 18.8±15.7, respectively; P=.021). 

The authors suggest that patients with better overall preoperative function, as represented by higher SANE scores, have a greater likelihood of poor functional outcomes after RSA for massive rotator cuff tears without glenohumeral arthritis. 

Comment: While it is apparent that patients with low preoperative SANE scores have a greater opportunity for a substantial preoperative to postoperative improvement improvement in the SANE score, it is not clear why patients with higher preoperative SANE scores would have lower postoperative SANE scores. Perhaps the issue lies with the SANE score itself. One of the weaknesses of the SANE score is that it does not separate the patient's assessment of pain, function, and satisfaction. In assessing the value of different methods for managing shoulders with massive cuff tears it is important to differentiate these three elements separately to inform discussions with prospective patients.

We live in a world where new methods for managing irreparable cuff tears without arthritis are rapidly coming and going: rehabilitation, debridement, partial repairs, Teflon grafts, GraftJacket, Restore patches, tendon transfers, superior capsular reconstruction, balloons and reverse total shoulder arthroplasty. 

When we treat a patient with an irreparable cuff tear, we need to know which clinical manifestations we are treating. Patients with irreparable cuff tears without arthritis range widely in their symptomatology, from asymptomatic to stiff, painful, unstable and/or pseudoparalytic. Thus it is not the diagnosis of massive cuff tear that indicates the choice of treatment, but rather the clinical manifestations of the cuff defect. The treatment for a patient with painful stiffness should start with a rehabilitation program whereas a patient with the same cuff pathology but with profound pseudoparalysis may wish to consider a reverse total shoulder.

Understanding the value to the patient of these different management approaches will come from studies that stratify patients by their pre-treatment comfort and function in addition to the specifics of their shoulder pathology.

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: https://twitter.com/shoulderarth

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Follow on facebook: https://www.facebook.com/frederick.matsen

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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).

The InSpace balloon (Stryker, USA): is this innovation of value to patients with irreparable rotator cuff tears?

The InSpace Ballon Implant was introduced to the U.S. medical device market by Stryker in July 2021 for arthroscopic treatment of massive irreparable rotator cuff tears (see this link). The InSpace device had previously received Conformité Européenne marking in 2010, and had been used in 29,000 procedures. The InSpace device is a saline-filled biodegradable balloon that is inserted surgically in the space between the humerus and the acromion. The cost of this device may vary, but locally it is about $7,000. This cost may or may not be covered by the patient's insurance.

The authors of the April 2022 Lancet publication,  Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial, assessed the outcomes of this device with debridement in comparison to debridement alone.

They point out that "new surgical procedures can expose patients to harm and should be carefully evaluated before widespread use". They  aimed to determine the effectiveness of the InSpace balloon (Stryker, USA), an innovative surgical device that has been recommended as treatment for rotator cuff tears that cannot be repaired (see this link).

They conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. Patients and assessors were blinded to group allocation, with intraoperative randomisation ensuring allocation concealment to ensure a low risk of bias.  The primary outcome was the Oxford Shoulder Score at 12 months.

They assessed allocated qualifying and consenting patients: 61 participants to the debridement only group and 56 to the debridement with InSpace Balloon group. 43% of participants were female, 57% were male. 

They obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with InSpace Balloon group (mean difference adjusted for adaptive design –4·2 [95% CI –8·2 to –0·26];p=0·037) favoring debridement alone over debridement with InSpace Balloon.

There was no difference in adverse events between the two groups. 

The authors found that the InSpace balloon is not an effective treatment, could be harmful, and is unlikely to be cost-effective. They concluded, "In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears."

Comment: This is the first published randomised trial on the balloon and the first study to clearly demonstrate an absence of benefit for the device. The fact that the FDA has "cleared" this device for use (see this link) and that the United States Centers for Medicare & Medicaid Services (CMS) has established a new Healthcare Common Procedure Coding System (HCPCS) code C9781 for outpatient hospitals and ambulatory surgery centers to report the insertion of Stryker's InSpace balloon implant (see this link) would seem to attach some legitimacy to the use of this device.  However, as pointed out in a recent post (see this link), these actions do not assure the safety, efficacy or cost-effectiveness of new innovative devices. 

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: https://twitter.com/shoulderarth

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Follow on facebook: https://www.facebook.com/frederick.matsen

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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).

30% unsatisfactory results for patients with massive rotator cuff tears having reverse total shoulder arthroplasty

Preoperative Single Assessment Numeric Evaluation Score Predicts Poor Outcomes After Reverse Shoulder Arthroplasty for Massive Rotator Cuff Tears Without Arthritis 

These authors conducted a retrospective case-control study on 60 patients (mean age, 71.4±7.4 years) who underwent reverse total shoulder (RSA) for massive rotator cuff tear without glenohumeral arthritis (Hamada score ≤3) and had a minimum of 2 years of follow-up. Procedures were performed at major medical centers by fellowship trained surgeons. The prostheses used were not described.

Baseline demographics, including age, sex, body mass index, and Charlson Comorbidity Index, were similar between those with poor outcomes and the controls.

Patients who were identified as having at least 1 of the below criteria for poor outcome were defined as cases (i.e.failures), and the remainder of the patients served as control subjects:

change in Simple Shoulder Test score of 1 or less

a postoperative ASES score of less than 50 

change in ASES score of less than 12

postoperative active forward elevation of less than 90°,

a change in SANE score of less than 29

or revision surgery. 

By this definition, 18 (30%) of patients had poor outcomes (case group). 

The case group had significantly worse postoperative Simple Shoulder Test (5.4±3.6 vs 8.5±2.4, Single Assessment Numeric Evaluation (SANE) (61.6±29.5 vs 84.9±14.1, and American Shoulder and Elbow Surgeons (58.9±22.5 vs 82.2±14.2 scores compared with the control group. 

Patients with poor outcomes had significantly higher preoperative SANE scores compared with control subjects (40.4±28.4 vs 18.8±15.7.

The authors concluded that "patients with better overall preoperative function, as represented by higher SANE scores, have a greater likelihood of poor functional outcomes after RSA for massive rotator cuff tears without glenohumeral arthritis. For these patients, alternative treatment options should be considered."

Comment: This article demonstrates that, in spite of having improvement in their outcome scores, a substantial percentage of patients receiving RSA for massive cuff tears failed to meet the authors' definition for a satisfactory result. From this one can see that the definition of "satisfactory" can have a strong influence on the conclusion. In this study, patients were not asked if they were satisfied or if they would have the same surgery again. However,  Reverse Shoulder Arthroplasty for the Treatment of Irreparable Rotator Cuff Tear without Glenohumeral Arthritis : reported that despite improved overall outcome scores, 32% of patients having RSA for massive cuff tears without arthritis (Hamada score ≤3) would not have the same surgery again. 

The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100 in which patients rate their current status in relation to a normal baseline. The observation that a higher preoperative function (as assessed by the SANE score >33) was associated with a higher percentage of unsatisfactory results is perplexing. Why higher "preoperative SANE scores are associated with a greater likelihood of poor outcomes after RSA for massive rotator cuff tears without glenohumeral arthritis" is unexplained in this manuscript.

Our takeaway is that patients with "massive cuff tears" are a very heterogenous group. Some of these patients actually have excellent comfort and function in spite of their pathology. Others have profound inability to use the shoulder. 

In our practice we often see patients with "massive cuff tears" referred for reverse total shoulder arthroplasty. Many of these achieve substantial improvement from a more conservative approach: either a simple exercise program (see this link) or from a less-invasive surgery, such as the smooth and move procedure (see this link). 

We reserve reverse total shoulders for those patients with massive cuff tears who are substantially disabled by pseudoparalysis or instability.

Much more knowledge needs to be gained before we know which patients with "massive cuff tears" are best managed with reverse total shoulder arthroplasty.

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: https://twitter.com/shoulderarth

Follow on facebook: click on this link

Follow on facebook: https://www.facebook.com/frederick.matsen

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).

Reverse total shoulder for massive irreparable cuff tears without arthritis - when? options?

 Reverse shoulder arthroplasty for massive irreparable rotator cuff tears: a reliable treatment method

These authors reviewed 203 patients having reverse total shoulder arthroplasty (RTSA) is a treatment option for massive irreparable rotator cuff tears (MIRCTs) without glenohumeral arthritis

with a mean follow-up of 50 months. 

Patients were divided into 4 groups based on preoperative shoulder active forward elevation (aFE) (<60°, <90°, 90°, >120°). Patients in each group had significant improvements in patient reported outcomes. Patient satisfaction was highest in the group with >120° preoperative aFE (44/44, 100%). There were 3 complications that required 2 revision surgeries.

113 of the shoulders demonstrated pseudoparalysis (active forward elevation <90 degrees while 75 had retained active elevation ≥ 90 degrees.

The pseudoparalytic shoulders had the highest improvements in patient reported outcomes (SST score change averaging 6.3 from 3.1 to 9.0, while the non-pseudoparalytic group improved by 4.8 from 5.4 to 10.2).

The pseudoparalytic shoulders had the highest improvements in active forward elevation (77 degrees from 50 to 128 degrees in comparison to the non-pseudoparalytic group that improved 12 degrees from 125 to 139 degrees).

Comment: This study demonstrates that amoung shoulder with massive irreparable cuff tears without arthritis, those with preoperative pseudoparalysis derive the highest benefit from a reverse total shoulder. Those having better preoperative comfort and function (no pseudoparalysis) have better postoperative comfort and function. 

These observations challenge surgeons to determine the "tipping point" for reverse total shoulder: how bad does a shoulder need to be before considering surgery. See this link and this link, Earlier intervention for less involved shoulders yields better outcomes, but less improvement.

For patients with massive irreparable cuff tears without arthritis and without pseudoparalysis, a less invasive procedure - the smooth and move - can allow immediate return to activities without the risks and down time associated with a reverse - see this link.

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

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 total shoulder arthroplasty (see this link).

The ream and run technique is shown in this link.

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

Shoulder rehabilitation exercises (see this link).

Follow on twitter: Frederick Matsen (@shoulderarth)

Massive Irreparable Rotator Cuff Tears without Arthritis

Reverse Shoulder Arthroplasty for Massive Irreparable Rotator Cuff Tears: A Reliable Treatment Method

These authors conducted a retrospective multi-institutional study (22 institutions, 24 surgeons) of 203 patients (average age, 71years) who underwent reverse total shoulder (RTSA) for massive irreparable rotator cuff tears (MIRCT) without glenohumeral arthritis after a mean follow-up of 50 months. Patients were divided into four groups based on preoperative shoulder active forward elevation (aFE) (<60 degrees, <90, ≥90, >120). 

Patients in each group had significant improvements in patient reported outcomes and range of motion. .

The complication rate was 1.6% and the reoperation rate was 1.1%).

The greatest improvement in patient reported outcomes were for the patient with pseudoparalysis (aFE  <90) in comparison to the non-pseudoparalytic group (aFE ≥ 90) (SPADI score (-62.23 vs. -49.18, p<.01), UCLA score (+17.25 vs. +13.47, p<.01), CS (+38.02 vs. +20.57, p<.01), and the SST score (+6.29 vs. +4.82, p<.01).

Significantly greater improvements in abduction and forward elevation were noted in the pseudoparalytic group compared to the non-pseudoparalytic group. 

While patient satisfaction was highest in the group with >120 degrees of preoperative active forward elevation, these patients experienced a non-significant decrease of (-5.45 degrees) in forward elevation.

Comment: Since almost all massive irreparable cuff tears are chronic, these patients have the opportunity to try to improve the comfort and function of their shoulder using gentle stretching and strengthening exercises (see this link).

This study indicates that the value of the reverse total shoulder to the patient (value = improvement in patient reported outcome divided by cost of the implant and procedure) is greatest for patients with pseudoparalysis. 

For those patients with massive irreparable cuff tears and preserved active elevation, other less costly and less invasive procedures, such as the smooth and move (see this link) may merit consideration. 

Depending on patient goals and the condition of the shoulder, other options for managing irreparable cuff tears include partial repair,  tendon transfer, and superior capsular reconstruction.

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

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 total shoulder arthroplasty (see this link).

The ream and run technique is shown in this link.

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

Shoulder rehabilitation exercises (see this link).

Follow on twitter: Frederick Matsen (@shoulderarth)