Superior Capsular Reconstruction vs. Partial Repair for Rotator Cuff Tears

(SCR Trial)

Recruiting at 1 trial location

Overseen By Ryan A Paul, MD, FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Subscapularis absence, Advanced arthropathy, Neurologic injury, others

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

Compensation: Varies

Number of Visits: 7

Duration: Surgery day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two surgical treatments for individuals with massive rotator cuff tears, which can cause significant shoulder pain and weakness. One group will undergo a newer method called superior capsular reconstruction (SCR), while the other will receive a standard procedure known as partial repair. The trial aims to determine which treatment is more effective and safer. Suitable candidates for this trial are those who have experienced shoulder pain or weakness due to large rotator cuff tears and have not found relief from at least three months of non-surgical treatments, such as physical therapy. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future treatment options.

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 prior data suggests that these techniques are safe for treating rotator cuff tears?

Research shows that a new method called Superior Capsular Reconstruction (SCR) can reduce pain and improve shoulder movement after rotator cuff surgery. One study found that patients who underwent this procedure experienced less pain and better shoulder movement within two years. Another study reported pain relief and improved shoulder function two to four years post-surgery.

Partial repair, a well-known method for treating large rotator cuff tears, has been used for a long time and is considered a standard procedure. Studies have shown that it provides excellent results and high patient satisfaction, even 10 years after surgery.

Both treatments have been studied for their safety and effectiveness. SCR is newer but shows promising results, while partial repair has a proven track record over many years. Available data indicates no clear evidence of serious safety concerns for either treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about superior capsular reconstruction for rotator cuff tears because it offers a novel approach by using a dermal allograft to reconstruct the superior capsule of the shoulder. Unlike standard treatments like partial repair, which may leave a residual defect, this technique aims to provide more stability and function by effectively bridging the gap left by torn tendons. This could potentially improve shoulder mobility and reduce pain more effectively than conventional methods, offering hope for better long-term outcomes for patients with massive rotator cuff tears.

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

This trial will compare Superior Capsular Reconstruction (SCR) with Partial Repair (PRCR) for rotator cuff tears. Studies have shown that SCR effectively restores shoulder function and reduces pain in individuals with severe rotator cuff tears that cannot be repaired. Specifically, research indicates that patients over 65 experienced consistent improvements two years after undergoing SCR. In contrast, PRCR, a long-established standard treatment, has improved outcomes and reduced the chance of re-tearing, though the improvements might not be as significant as with more extensive repairs. Both treatments show promise, but the newer SCR technique may offer better long-term results for some patients. ^{1 3 4 6 7}

Who Is on the Research Team?

Patrick Henry, MD, FRCSC

Principal Investigator

Sunnybrook Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals who have massive rotator cuff tears larger than 4 cm, involving the supraspinatus and infraspinatus, that haven't improved after at least three months of non-surgical treatment. Participants must be experiencing shoulder pain or weakness but cannot have had previous surgery on the affected shoulder or certain conditions like advanced joint disease.

Inclusion Criteria

Informed consent obtained

My tear was found to be irreparable during surgery.

I have shoulder pain or weakness.

Exclusion Criteria

My shoulder's subscapularis muscle is either missing or cannot be repaired.

I have advanced shoulder damage due to a tear or arthritis.

I have had a tear injury within the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo either superior capsular reconstruction or partial repair based on randomization

Surgery day

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for safety and effectiveness with regular clinic visits

2 years

5 visits (in-person) at 6 weeks, 3 months, 6 months, 1 year, and 2 years post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Partial Repair
• Superior Capsular Reconstruction

Trial Overview

The study compares two surgical techniques for treating massive irreparable rotator cuff tears: Superior Capsular Reconstruction (SCR) and Partial Rotator Cuff Repair (PRCR). It's a pilot randomized control trial to determine which method is more effective before conducting a larger clinical trial.

How Is the Trial Designed?

Group I: Superior Capsular Reconstruction Experimental Treatment 1 Intervention

Patients will be treated with the new technique of superior capsular reconstruction with dermal allograft.

Group II: Partial Repair Active Control 1 Intervention

Patients will have a partial repair with residual defect as an established standard procedure.

Partial Repair is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Partial Rotator Cuff Repair for:

• Massive irreparable rotator cuff tears

Approved in European Union as Partial Rotator Cuff Repair for:

• Massive irreparable rotator cuff tears

Approved in Canada as Partial Rotator Cuff Repair for:

• Massive irreparable rotator cuff tears

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

St. Joseph's Healthcare Hamilton

Collaborator

Trials

203

Recruited

26,900+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

Women's College Hospital

Collaborator

Trials

108

Recruited

43,700+

Published Research Related to This Trial

Limb-girdle muscular dystrophy type 2A (LGMD2A) is caused by mutations in the CAPN3 gene, leading to muscle fiber death and early clinical symptoms in specific muscle groups, but no clinical differences are observed based on mutation type.

Experimental therapies using adeno-associated virus (AAV) vectors show promise for gene transfer in LGMD2A, indicating a potential avenue for future treatments despite the lack of curative options currently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limb-girdle muscular dystrophy 2A. Gallardo, E., Saenz, A., Illa, I.[2021]

In a study involving 36 cadaveric specimens, the fixation method using three 3.5-mm knotless screw-in anchors demonstrated significantly greater load to failure compared to a 4-anchor hybrid technique, suggesting it provides better stability for superior capsular reconstruction (SCR) in patients with irreparable rotator cuff tears.

All fixation techniques showed similar graft elongation and stiffness, indicating that while the number of anchors may vary, the biomechanical performance in terms of elongation and stiffness remains consistent across methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Comparison of 3 Glenoid-Side Fixation Techniques for Superior Capsular Reconstruction. Pogorzelski, J., Muckenhirn, KJ., Mitchell, JJ., et al.[2019]

In a study of 93 unrelated families with limb-girdle muscular dystrophy type 2 (LGMD2), 29 families were identified with LGMD2A, and 22.6% of these had mutations in the CAPN3 gene, which is linked to this condition.

The researchers discovered six new mutations and confirmed nine previously reported mutations in the CAPN3 gene, suggesting that certain mutations are more common and could aid in diagnosing LGMD2A in Turkey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calpain-3 mutations in Turkey. Balci, B., Aurino, S., Haliloglu, G., et al.[2022]

In a study of 22 patients undergoing superior capsular reconstruction (SCR) for irreparable rotator cuff tears, those with intact grafts showed significant decreases in humeral head superior translation at 6 months and 1 year post-surgery, indicating improved shoulder stability.

Patients who experienced retears did not show improvement in humeral head translation, suggesting that early surgical intervention before significant deterioration in acromiohumeral distance (AHD) is crucial for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Dynamic In Vivo Shoulder Kinematics Before and After Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears. Lee, SJ., Min, YK., Chung, IK., et al.[2022]

A systematic evaluation of 13 patients with calpainopathy revealed a wide age range of symptom onset (2-45 years) and confirmed the characteristic muscle involvement patterns, including early pelvic girdle weakness and scapular winging.

The study identified early primary contractures as a significant feature of calpainopathy, highlighting the importance of recognizing these clinical patterns for accurate diagnosis and prognosis, especially in sporadic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The phenotype of calpainopathy: diagnosis based on a multidisciplinary approach. Pollitt, C., Anderson, LV., Pogue, R., et al.[2019]

Superior capsular reconstruction is emerging as a promising surgical option for patients with massive and irreparable rotator cuff tears, showing early improvements in pain, range of motion, and function.

Despite limited clinical and long-term data, initial results indicate that this procedure may enhance validated outcome measurements for patients suffering from these types of injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: SCR: Substantial Confusion Remains. Favorito, P., Stephens, B.[2019]

Superior capsular reconstruction is a promising surgical option for treating massive irreparable rotator cuff tears, as it aims to restore the normal biomechanics of the shoulder joint and prevent superior subluxation.

Combining this technique with partial rotator cuff repair can enhance shoulder function and kinematics, offering a more comprehensive approach to managing these challenging injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All-Arthroscopic Superior Shoulder Capsule Reconstruction With Partial Rotator Cuff Repair. Sutter, EG., Godin, JA., Garrigues, GE.[2022]

In a study of 180 patients, those who underwent superior capsule reconstruction (SCR) with concomitant infraspinatus rotator cuff repair (SCR+RCR) showed significantly better shoulder function and ASES Index scores at 24 months compared to those who had SCR alone.

Both SCR and SCR+RCR resulted in significant improvements in pain and function over two years, indicating that adding infraspinatus repair can enhance outcomes for patients with irreparable rotator cuff tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial Rotator Cuff Repair Provides Improved Patient-Reported Outcome Measures Following Superior Capsule Reconstruction (SCR). Woodmass, JM., Wagner, ER., Welp, KM., et al.[2022]

In a study of seven patients with limb girdle muscular dystrophy 2A, early and severe contractures were observed, particularly affecting the posterior thigh muscles, which can complicate diagnosis with other conditions.

Muscle MRI findings were crucial in distinguishing limb girdle muscular dystrophy 2A from similar muscle diseases, suggesting that MRI can be a valuable tool for accurate diagnosis and guiding further genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle MRI findings in patients with limb girdle muscular dystrophy with calpain 3 deficiency (LGMD2A) and early contractures. Mercuri, E., Bushby, K., Ricci, E., et al.[2022]

In a study of 75 patients from 26 Brazilian families with LGMD2A, researchers identified 47 mutated alleles linked to the disease, with a significant concentration of mutations in just 6 exons, which could aid in more efficient genetic diagnosis.

Protein analysis revealed that nearly all patients had total or partial calpain deficiency, and the study found that African-Brazilian patients experienced more severe symptoms compared to Caucasian patients, suggesting that genetic background may influence disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical variability in calpainopathy: what makes the difference? de Paula, F., Vainzof, M., Passos-Bueno, MR., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Outcome of partial repair of massive rotator cuff tears with ...

Our study has shown that allograft bridged repairs produce greater improvement in outcome scores at 2 years postoperatively compared to partial repair alone. It ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1877056821001304

Comparison between partial and full coverage repair in ...

The purpose of this study was to compare re-tear rate and clinical outcome of arthroscopic repair of massive rotator cuff tears.

3.

josr-online.biomedcentral.com

josr-online.biomedcentral.com/articles/10.1186/s13018-025-05975-x

Improved clinical outcomes after arthroscopic partial rotator ...

A retrospective review was conducted on arthroscopic rotator cuff repairs performed by a single surgeon between January 2018 and December 2022.

4.

arthroscopyjournal.org

arthroscopyjournal.org/article/S0749-8063(25)00420-7/fulltext

Arthroscopic Repair of Partial-Thickness Rotator Cuff Tears ...

Editorial Commentary: Arthroscopic Repair of Partial-Thickness Rotator Cuff Tears Shows Long-Term Clinically Significant Improved Outcomes.

5.

trialx.com

trialx.com/clinical-trials/listings/235851/superior-capsular-reconstruction-vs-partial-repair-for-massive-rotator-cuff-tears/?&radius=50

Superior Capsular Reconstruction vs. Partial Repair for ...

Arthroscopic partial rotator cuff repair (PRCR) is arguably the gold-standard surgical option with the longest record of use. The new technique ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37306068/

Minimum 10-Year Outcomes After Arthroscopic Repair of ...

Arthroscopic repair of PTRCTs results in excellent clinical outcomes and high patient satisfaction at minimum 10-year follow-up.

7.

arthroscopytechniques.org

arthroscopytechniques.org/article/S2212-6287(25)00039-8/fulltext

Biologically Enhanced Repair of Interstitial Rotator Cuff ...

Arthroscopic repair of interstitial tears by first completing the tear yielded improved clinical outcomes including pain and function but showed a retear rate ...