Repair vs Replacement for Rotator Cuff Tears

Recruiting at 1 trial location

Overseen By Alexandre Lädermann, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: La Tour Hospital

Disqualifiers: Arthritis, Infection, Non-compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat massive rotator cuff tears, which cause shoulder pain and limit movement. It compares two treatments: arthroscopic surgery, a minimally invasive procedure that reattaches the torn tendon, and reverse shoulder arthroplasty, which replaces the shoulder joint to improve function and reduce pain. The goal is to determine which option provides better outcomes for patients. Suitable candidates have experienced a non-traumatic rotator cuff tear that hasn't improved with other treatments and have specific MRI or X-ray results. As an unphased trial, this study allows patients to contribute to important research that could enhance treatment options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that arthroscopic surgery for rotator cuff tears is usually well-tolerated, with fewer risks than open surgery, such as less damage to surrounding tissue and quicker recovery times. Major problems, like re-tearing or a stiff shoulder, occur in about 17.3% of cases, but the chance of serious complications remains low.

Similarly, reverse shoulder arthroplasty (RSA) is considered safe. Studies indicate that the implants last well, with a 90.7% survival rate over several years, and patients often experience less pain and improved shoulder movement. RSA is a reliable option for those with severe rotator cuff damage.

Both treatments have their advantages and disadvantages, but research generally supports their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments for massive degenerative rotator cuff tears because they offer distinct approaches compared to standard care options like physical therapy, traditional open surgery, or conventional shoulder arthroplasty. Arthroscopic surgery is unique because it allows for minimally invasive reattachment of the torn tendon using anchors and sutures, which can lead to quicker recovery times and less postoperative pain. On the other hand, reverse shoulder arthroplasty provides a complete shoulder joint replacement with a reverse design prosthesis, which can be particularly beneficial for patients with severe tears where traditional repairs might fail. By utilizing these innovative techniques, there’s potential for improved functional outcomes and patient satisfaction.

What evidence suggests that this trial's treatments could be effective for rotator cuff tears?

This trial will compare two treatments for rotator cuff tears: arthroscopic surgery and reverse shoulder arthroplasty. Studies have shown that repairing a torn rotator cuff with a small camera and tools (arthroscopic surgery) leads to less pain and quicker recovery than traditional open surgery. Patients often experience less damage to surrounding tissue and return to normal activities sooner. Conversely, reverse shoulder arthroplasty, which replaces the shoulder joint with an artificial one, significantly improves shoulder function and reduces pain. Research indicates that this option is particularly effective for severe rotator cuff tears. Both treatments offer benefits, but reverse shoulder arthroplasty might provide better long-term improvements in movement and quality of life. ^{1 4 6 7 8}

Who Is on the Research Team?

Alexandre Lädermann, MD

Principal Investigator

La Tour hospital, Meyrin (1217) Geneva, Switzerland

Patrick Denard, MD

Principal Investigator

Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA

Are You a Good Fit for This Trial?

This trial is for patients with massive, non-traumatic rotator cuff tears that haven't improved with conservative treatment. They must have specific pre-operative images and be able to consent and follow the study procedures. People with advanced shoulder arthritis, previous surgeries, infections, or conditions affecting their ability to participate are excluded.

Inclusion Criteria

I agree to join the study willingly.

I have a large shoulder tendon tear that didn't improve with basic treatments.

I have had specific X-rays and an MRI that show no signs of injury.

Exclusion Criteria

Known or suspected non-compliance, drug or alcohol abuse

Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study

I am unable to make decisions for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either arthroscopic surgery or reverse shoulder arthroplasty to treat massive degenerative rotator cuff tears

6-8 weeks

Multiple visits for surgical procedure and initial recovery

Follow-up

Participants are monitored for safety, effectiveness, and functional outcomes after treatment

24 months

Regular follow-up visits including radiographic evaluations and assessments

What Are the Treatments Tested in This Trial?

Interventions

• Arthroscopy
• Reverse Shoulder Arthroplasty

Trial Overview The study compares functional outcomes between two treatments for severe rotator cuff injuries: arthroscopic repair (RCR) and reverse shoulder arthroplasty (RSA). It's a prospective randomized study which means participants will be randomly assigned to one of these treatments to see which one works better.

How Is the Trial Designed?

Group I: Reverse shoulder arthroplasty Experimental Treatment 1 Intervention

The problems induced by the massive degenerative rotator cuff tear are solved by a complete replacement of the shoulder joint with a prosthesis (reverse design).

Group II: Arthroscopic surgery Active Control 1 Intervention

The massive degenerative rotator cuff tear are treated by arthroscopy. It consists in reattaching the torn tendon with anchors and sutures.

Arthroscopy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Arthroscopy for:

• Rotator cuff tears
• Shoulder injuries
• Joint disorders

Approved in United States as Arthroscopy for:

• Rotator cuff tears
• Shoulder injuries
• Joint disorders
• Sports injuries

Approved in Canada as Arthroscopy for:

• Rotator cuff tears
• Shoulder injuries
• Joint disorders

Approved in Japan as Arthroscopy for:

• Rotator cuff tears
• Shoulder injuries
• Joint disorders

Who Is Running the Clinical Trial?

La Tour Hospital

Lead Sponsor

Trials

16

Recruited

246,000+

Published Research Related to This Trial

Patients who had previously undergone rotator cuff repair (RCR) and then received reverse shoulder arthroplasty (RSA) experienced lower postoperative functional scores and higher pain scores compared to those undergoing primary RSA without prior repair, based on an analysis of 2176 shoulders from six studies.

Despite the observed differences in outcomes, the variations in functional and pain scores between the two groups were below the minimal clinically important difference, suggesting that while prior RCR may impact recovery, the clinical significance of these differences is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of reverse shoulder arthroplasty in patients with previous rotator cuff repair: a systematic review and meta-analysis. Tantone, RP., Al-Humadi, S., VanHelmond, T., et al.[2023]

In a study of 37 patients (average age 79) who underwent reverse shoulder arthroplasty (RSA) for pseudoparalysis due to cuff tear arthropathy, significant improvements in shoulder function were observed over a 5-year follow-up, with mean Constant and Oxford scores increasing from 34.2 to 71.0 and 15 to 33, respectively.

Despite a high incidence of scapular notching (68% of patients), this condition did not negatively impact overall function or patient satisfaction, indicating that RSA can be an effective treatment option with good long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reverse shoulder arthroplasty in 41 patients with cuff tear arthropathy with a mean follow-up period of 5 years. Al-Hadithy, N., Domos, P., Sewell, MD., et al.[2022]

Reverse shoulder arthroplasty (RSA) can lead to satisfactory outcomes for many patients with functionally irreparable rotator cuff tears (FIRCT), but those with good preoperative motion or isolated loss of external rotation may experience lower satisfaction.

To optimize RSA outcomes, it's important to balance minimizing impingement and enhancing the function of remaining muscles, and in some cases, tendon and muscle transfers may improve results for patients with significant weakness or deltoid dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Optimize Reverse Shoulder Arthroplasty for Irreparable Cuff Tears. Sanchez-Sotelo, J., Athwal, GS.[2020]

Patients who underwent reverse shoulder arthroplasty (RSA) after a previous rotator cuff repair showed significant improvements in shoulder function, as measured by ASES scores, from a baseline of 43.1 to 76.6 two years post-surgery.

Despite these improvements, there was no significant difference in outcomes between patients with prior rotator cuff repair and those without, indicating that previous surgery does not negatively impact early recovery after RSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does having a rotator cuff repair prior to reverse total shoulder arthroplasty influence the outcome? Erickson, BJ., Ling, D., Wong, A., et al.[2019]

Patients undergoing reverse shoulder arthroplasty (RSA) for revision had significantly lower shoulder function scores compared to those who had primary RSA, indicating that primary procedures generally yield better outcomes.

The complication rate was higher in the revision RSA group (35.7%) compared to the primary RSA group (17.8%), suggesting that while revision RSA can improve function, it carries a greater risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is reverse shoulder arthroplasty a reasonable alternative for revision arthroplasty? Austin, L., Zmistowski, B., Chang, ES., et al.[2022]

Reverse shoulder arthroplasty (RSA) significantly improves pain-free range of motion and overall shoulder function in patients with massive irreparable rotator cuff tears and cuff tear arthropathy, based on a systematic review of seven studies.

Despite its effectiveness, RSA is associated with a notable complication rate of 17.4%, with heterotopic ossification being the most common issue, affecting 6.6% of patients, and 7.3% requiring revision surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reverse shoulder arthroplasty for massive irreparable rotator cuff tears and cuff tear arthropathy: a systematic review. Petrillo, S., Longo, UG., Papalia, R., et al.[2018]

In a study of 49 patients who underwent reverse shoulder arthroplasty (RSA) for either shoulder trauma or arthritis, the functional outcomes at 1 year were similar for both groups, indicating that RSA is effective for treating complex proximal humeral fractures.

The overall complication rate was 20.4%, with a significantly higher rate in patients with arthritis (34.8%) compared to those with trauma (7.7%), suggesting that RSA may be safer for trauma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term comparative outcomes between reverse shoulder arthroplasty for shoulder trauma and shoulder arthritis: a Southeast Asian experience. Ng, JPH., Tham, SYY., Kolla, S., et al.[2022]

In a study of 284 patients undergoing reverse shoulder arthroplasty (RSA), the rate of instability was similar between primary (5%) and revision (8%) surgeries, while infection rates were higher in the revision group (7%) compared to the primary group (1%).

Patients with an irreparable subscapularis tendon had a significantly higher rate of instability (12%) compared to those with a repairable tendon (less than 1%), indicating that certain diagnoses can influence complication rates after RSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the instability and infection rates after reverse shoulder arthroplasty? Trappey, GJ., O'Connor, DP., Edwards, TB.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10796185/

Comparison of Outcomes between Open and Arthroscopic ... Both methods resulted in similar recovery times and functional capacity scores, but patients treated with the open method reported slightly lower pain levels.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12180584/

Outcomes of Rotator Cuff Repair: Open vs. Arthroscopic ... Findings suggest that arthroscopic RCR compared to open RCR offers advantages such as reduced tissue disruption, shorter recovery times, and lower infection ...

3. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/145056-the-role-of-arthroscopy-as-minimal-invasive-for-shoulder-trauma-literature-review

The Role of Arthroscopy As Minimal Invasive for Shoulder ... Shoulder arthroscopy has several benefits over open surgery, such as less comorbidity, faster recovery, and social and economic benefits.

4. cureus.com cureus.com/articles/301425-rotator-cuff-repair-by-all-arthroscopic-versus-mini-open-technique-a-comparison-of-clinical-and-functional-outcome.pdf

Rotator Cuff Repair by All-Arthroscopic Versus Mini-Open ... Conclusion: The outcomes of all-arthroscopic and mini-open rotator cuff repair surgery are equivocal in terms of both clinical and functional ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1479666X21001918

Arthroscopic versus mini-open rotator cuff repair: A meta ... An all-arthroscopic rotator cuff repair (ASR) may result in less postoperative pain and better functional outcomes than the mini-open (MOR) approach.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11181071/

Better short-term outcomes of mini-open rotator cuff repair ... Complications, including anchor placement issues, frozen shoulder, infection, and re-rupture, occurred in 17.3% of patients overall. Re-rupture ...

7. bmj.com bmj.com/content/378/bmj-2021-069901

Serious adverse event rates and reoperation after ... The findings of this study suggest that risks of serious adverse events associated with common shoulder arthroscopy procedures are low.

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00260949

Outcome Following Surgery to Repair Rotator Cuff Tears Arthroscopic rotator cuff repair is less invasive and exposes the patient to fewer risks than open surgery. Once this pilot study is completed the next step ...