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

Trial Summary

What is the purpose of this trial?

Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established. The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial.

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 Superior Capsular Reconstruction vs. Partial Repair for Rotator Cuff Tears?

Early results suggest that superior capsular reconstruction may help improve pain, range of motion, and function in patients with massive rotator cuff tears. Partial rotator cuff repair has also been shown to improve shoulder movement and can be combined with superior capsular reconstruction for better outcomes. ^{1 2 3 4 5}

How does the treatment Superior Capsular Reconstruction differ from other treatments for rotator cuff tears?

Superior Capsular Reconstruction (SCR) is a unique surgical treatment for rotator cuff tears that involves using a graft to stabilize the shoulder joint by reconstructing the superior capsule, which is different from traditional rotator cuff repair that focuses on directly repairing the torn tendons. This approach is particularly beneficial for patients with irreparable rotator cuff tears, as it helps restore shoulder function and stability by preventing upward movement of the humeral head. ^{6 7 8 9 10}

Research Team

Patrick Henry, MD, FRCSC

Principal Investigator

Sunnybrook Health Sciences

Eligibility Criteria

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

I have shoulder pain or weakness.

My tear was found to be irreparable during surgery.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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 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]

References

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

Editorial Commentary: SCR: Substantial Confusion Remains. [2019]

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

Comparison of Dynamic In Vivo Shoulder Kinematics Before and After Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears. [2022]

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

All-Arthroscopic Superior Shoulder Capsule Reconstruction With Partial Rotator Cuff Repair. [2022]

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

Partial Rotator Cuff Repair Provides Improved Patient-Reported Outcome Measures Following Superior Capsule Reconstruction (SCR). [2022]

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

Biomechanical Comparison of 3 Glenoid-Side Fixation Techniques for Superior Capsular Reconstruction. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The phenotype of calpainopathy: diagnosis based on a multidisciplinary approach. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Muscle MRI findings in patients with limb girdle muscular dystrophy with calpain 3 deficiency (LGMD2A) and early contractures. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Clinical variability in calpainopathy: what makes the difference? [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Limb-girdle muscular dystrophy 2A. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Calpain-3 mutations in Turkey. [2022]