Shoulder Surgery for Rotator Cuff Tears

(SCR Trial)

Overseen By Sara Sparavalo, MASc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Subscapular tear, Osteoarthritis, Diabetes, Pregnancy, Cancer, others

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Trial Summary

What is the purpose of this trial?

To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.

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 Bridging Rotator Cuff Reconstruction, GRAFTJACKET™ allograft, Superior Capsular Reconstruction, Arthroscopic Superior Capsular Reconstruction, SCR?

Research shows that superior capsular reconstruction (SCR) is a promising treatment for large rotator cuff tears, with studies indicating that different graft types, including acellular dermal allografts, can improve shoulder function and reduce pain. These grafts have shown similar outcomes and complication rates, suggesting they are effective for patients with irreparable rotator cuff tears. ^{1 2 3 4 5}

Is shoulder surgery for rotator cuff tears generally safe?

The research on superior capsular reconstruction (SCR) for rotator cuff tears suggests it is generally safe, with studies focusing on its effectiveness and complication profile. While specific safety data is not detailed, the procedure is commonly used and studied, indicating a level of safety in humans. ^{2 6 7 8 9}

How is the treatment GRAFTJACKET™ allograft, Superior Capsular Reconstruction different from other treatments for rotator cuff tears?

Superior Capsular Reconstruction (SCR) with GRAFTJACKET™ allograft is unique because it uses a dermal allograft to restore shoulder joint stability and improve function in patients with massive, irreparable rotator cuff tears, especially in active individuals. This treatment is particularly beneficial for those who are not ideal candidates for more invasive procedures like reverse total shoulder arthroplasty. ^{1 5 8 10 11}

Research Team

Ivan Wong, MD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

This trial is for individuals with a confirmed MRI diagnosis of large or massive rotator cuff tears involving two tendons in the shoulder. Candidates should not have severe shoulder issues, uncontrolled diabetes, infections, cancer, or be pregnant. A good nutritional state and no paralysis or contracture of the affected shoulder are required.

Inclusion Criteria

My MRI shows a large tear in two tendons of my shoulder.

Exclusion Criteria

I have a stiff shoulder that doesn't move well.

I have a shoulder condition due to a tendon tear.

I have shoulder arthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Routine radiographs and pre-operative MRI are obtained; informed consent process

1 week

Surgical Treatment

Patients undergo either bridging reconstruction or superior capsular reconstruction

1 day

Postoperative Immobilization

Shoulder immobilized in a sling; passive motion allowed

8 weeks

Rehabilitation

Progression to active shoulder motion and strengthening

4 weeks

Follow-up

Regular follow-up appointments for clinical examination and imaging

24 months

Visits at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Treatment Details

Interventions

• Bridging Rotator Cuff Reconstruction
• GRAFTJACKET™ allograft
• Superior Capsular Reconstruction

Trial Overview The study aims to compare two surgical techniques for repairing massive rotator cuff tears: bridging reconstruction and superior capsular reconstruction using GRAFTJACKET™ allograft (human dermal tissue).

Participant Groups

Group I: Bridging Rotator Cuff Group Experimental Treatment 2 Interventions

Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using GRAFTJACKET™ allograft.

Group II: Superior Capsular Group Active Control 1 Intervention

Superior Capsular Reconstruction of massive rotator cuff tear

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

References

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

Glenohumeral Superior Translation and Subacromial Contract Pressure Are Both Improved With Superior Capsular Reconstruction: A Systematic Review and Meta-Analysis of Biomechanical Investigations. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Research progress of indication and treatment of graft in shoulder superior capsular reconstruction for rotator cuff tear]. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Longitudinal efficacy of acellular dermal allograft following superior capsular reconstruction of irreparable rotator cuff tears. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Superior capsular reconstruction for irreparable rotator cuff tears: Autografts versus allografts. [2022]

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

Clinical and Functional Outcomes by Graft Type in Superior Capsular Reconstruction: A Systematic Review and Meta-analysis. [2022]

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

Arthroscopic Superior Capsular Reconstruction for Massive, Irreparable Rotator Cuff Tears: A Systematic Review of Modern Literature. [2020]

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

Superior Capsular Reconstruction Using Acellular Dermal Allograft Combined With Remaining Rotator Cuff Augmentation Improved Shoulder Pain and Function at 1 Year After The Surgery. [2022]

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

Editorial Commentary: Shoulder Superior Capsular Reconstruction With Dermal Allograft Is Useful for Active Patients With Massive Irreparable Rotator Cuff Tear. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Reliability of a Novel Preoperative Protocol for Determining Graft Sizes for Superior Capsular Reconstruction Using Plain Film Radiography. [2023]

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

Comparison of Superior Capsular Reconstruction and Partial Infraspinatus Repair: A Matched-Pair Analysis of Irreparable Rotator Cuff Tears. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Case study: failure of superior capsular reconstruction using dermal allograft. [2022]