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

Trial Summary

What is the purpose of this trial?

Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).

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.

What data supports the effectiveness of the treatment for rotator cuff tears?

Research shows that reverse shoulder arthroplasty (RSA) is effective for patients with rotator cuff issues, such as cuff tear arthropathy, and can improve shoulder function in complex cases. RSA is also used successfully for shoulder trauma and arthritis, indicating its versatility and effectiveness in treating shoulder problems. ^{1 2 3 4 5}

Is reverse shoulder arthroplasty generally safe for humans?

Reverse shoulder arthroplasty (RSA) is a common treatment for shoulder issues like rotator cuff tears and has been studied for its safety. Some concerns include higher rates of complications like instability and infection compared to other shoulder surgeries, but it is generally considered an accepted and safe option for certain conditions. ^{2 4 5 6 7}

How is the treatment of reverse shoulder arthroplasty different for rotator cuff tears?

Reverse shoulder arthroplasty (RSA) is unique because it is specifically designed for patients with massive irreparable rotator cuff tears, where traditional repair methods are not effective. Unlike standard shoulder replacements, RSA changes the mechanics of the shoulder joint to rely on different muscles, making it suitable for those with severe rotator cuff damage. ^{1 2 5 7 8}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Does having a rotator cuff repair prior to reverse total shoulder arthroplasty influence the outcome? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Reverse shoulder arthroplasty in 41 patients with cuff tear arthropathy with a mean follow-up period of 5 years. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Is reverse shoulder arthroplasty a reasonable alternative for revision arthroplasty? [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Short-term comparative outcomes between reverse shoulder arthroplasty for shoulder trauma and shoulder arthritis: a Southeast Asian experience. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

How to Optimize Reverse Shoulder Arthroplasty for Irreparable Cuff Tears. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

What are the instability and infection rates after reverse shoulder arthroplasty? [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Reverse shoulder arthroplasty for massive irreparable rotator cuff tears and cuff tear arthropathy: a systematic review. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of reverse shoulder arthroplasty in patients with previous rotator cuff repair: a systematic review and meta-analysis. [2023]