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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical methods to repair massive rotator cuff tears in the shoulder. One method uses a human tissue graft (GRAFTJACKET™ allograft) to bridge the tear, while the other employs superior capsular reconstruction (also known as Arthroscopic Superior Capsular Reconstruction or SCR). The goal is to determine which method more effectively repairs these large tears. Individuals with an MRI-confirmed tear in the supraspinatus and infraspinatus tendons may qualify for this trial. As an unphased trial, this study provides an opportunity to contribute to valuable research that could enhance surgical outcomes 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 has shown that both treatments tested in the trial have been safe in previous studies.

For Superior Capsular Reconstruction, studies have found it significantly reduces pain and improves shoulder function. In follow-ups lasting up to 51 months, patients reported good results with few serious side effects. This procedure is considered safe compared to other treatments, with many patients experiencing better shoulder movement and less pain.

For Bridging Rotator Cuff Reconstruction, using a dermal allograft (a graft made from donated human skin) has improved patient outcomes. Research indicates that patients achieve better results with this procedure than with partial repairs alone. Over several years of follow-up, patients have seen significant improvements without major safety concerns.

Both treatments appear well-tolerated and effective based on past research, making them promising options for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments for massive rotator cuff tears because they offer innovative approaches to repair. The Superior Capsular Reconstruction uses a graft to stabilize and support the shoulder joint, potentially offering more durability than traditional methods like tendon repair. Meanwhile, the Bridging Rotator Cuff Reconstruction employs the GRAFTJACKET™ allograft, which is designed to bridge gaps in the rotator cuff, promoting better tissue integration and healing. These techniques could provide enhanced stability and improved outcomes for patients compared to conventional surgical repairs.

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

This trial will compare two treatments for large rotator cuff tears. Participants in the Superior Capsular Group will receive Superior Capsular Reconstruction (SCR). Research has shown that SCR can reduce pain and improve shoulder movement in the short term, with healing rates between 45% and 90%. Although some patients required additional surgery, many experienced improvement two years after the procedure. Participants in the Bridging Rotator Cuff Group will undergo Bridging Rotator Cuff Reconstruction (BRR) using GRAFTJACKET™ allograft. Studies suggest that BRR outperforms partial repairs alone, has a low risk of causing further joint problems over five years, and helps prevent structural failures. Both methods show promise for improving shoulder function and reducing pain in individuals with large rotator cuff tears. ^{1 6 7 8 9}

Who Is on the Research Team?

Ivan Wong, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5441617/

Outcome of partial repair of massive rotator cuff tears with ... Human tissue matrix allograft provides a better outcome for open bridging of irreparable rotator cuff tears than partial repair alone.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1058274625002125

Bridging reconstruction for massive rotator cuff tears has a ... The results of this study show that BRR with dermal allograft has promising results over a 5-year follow-up with low progression to rotator cuff arthropathy ...

3. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(24)00489-4/fulltext

Bridging Reconstruction With Interpositional Dermal ... BRR results in a significantly reduced structural failure rate and a trend toward better preservation of supraspinatus muscle mass compared with maximal repair.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10839609/

Primary Rotator Cuff Bridging Reconstruction Shows Better ... BR using dermal allograft for large/massive irreparable rotator cuff tears showed improvement of functional outcomes, with primary cases resulting in better ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0749806324004894

Bridging Reconstruction With Interpositional Dermal ... BRR results in a significantly reduced structural failure rate and a trend toward better preservation of supraspinatus muscle mass compared with maximal repair.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8485417/

Bridging Allograft Reconstruction Is Superior to Maximal ... Rotator cuff bridging reconstruction using a dermal allograft demonstrated improved patient-reported outcomes as measured using the WORC index 2 years ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03425500

NCT03425500 | Massive Rotator Cuff Tear Reconstruction To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806321007295

Interposition Graft Bridging Reconstruction of Irreparable ... Our results showed that patients' clinical outcome scores significantly improved with an average of 5-year follow-up, which demonstrates that bridging ...

9. withpower.com withpower.com/trial/phase-rotator-cuff-tear-arthropathy-4-2018-99be3

Shoulder Surgery for Rotator Cuff Tears (SCR Trial) The research on superior capsular reconstruction (SCR) for rotator cuff tears suggests it is generally safe, with studies focusing on its effectiveness and ...