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

Recruiting in Cleveland (>99 mi)

+2 other locations

Overseen By John T Strony, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Robert J. Gillespie

Disqualifiers: Pregnant, Arthritis, Infection, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

105 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and Patient Reported Outcomes Measurement Information System (PROMIS) 29 score at 6 weeks, 3, 6, 12, and 24 months post-operatively. The two surgical modalities of interest are partial rotator cuff repair alone and partial rotator cuff repair with superior capsule reconstruction (SCR). The secondary objective of this study is determine the failure rate of partial repair alone vs. partial repair with SCR via magnetic resonance imaging (MRI) at 12 months post-operatively. The information gained from this investigation will be useful to discern if SCR provides any benefit to patients with irreparable rotator cuff tears. The investigators hypothesize that there is no statistically significant difference in pain and functional outcomes between partial rotator cuff repair alone versus partial rotator cuff repair with SCR. In addition, the investigators hypothesize that the failure rate will be significantly higher in patients undergoing partial rotator cuff repair with SCR.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Rotator Cuff Tears?

Research suggests that partial rotator cuff repair can improve shoulder movement and stability, even if the tear is massive and irreparable. Superior capsular reconstruction is another option that helps restore shoulder function by preventing the upper part of the shoulder joint from moving out of place. ^{1 2 3 4 5}

Is Partial Rotator Cuff Repair or Superior Capsular Reconstruction safe for humans?

The research articles suggest that both Partial Rotator Cuff Repair and Superior Capsular Reconstruction are generally considered safe for treating massive rotator cuff tears, as they are commonly performed surgical techniques. However, like any surgery, they may have risks such as retears or complications related to the procedure. ^{1 2 3 6 7}

How does Partial Rotator Cuff Repair differ from other treatments for rotator cuff tears?

Partial Rotator Cuff Repair is a simpler surgical option for massive rotator cuff tears compared to Superior Capsular Reconstruction, but it may lead to frequent retears. It is often used when the tear is partially repairable and can be combined with other techniques to improve shoulder function. ^{2 3 6 8 9}

Eligibility Criteria

This trial is for adults over 18 with irreparable rotator cuff tears, as seen on MRI. It's not for those with severe joint issues (Hamada grade ≥3), arthritis visible on X-rays, shoulder infections, neurological problems affecting the shoulder, workers' compensation claims, smokers, or if a complete repair is possible during surgery. Pregnant women and individuals who are illiterate or don't speak English are also excluded.

Inclusion Criteria

Irreparable rotator cuff tear suspected on pre-operative MRI

I am 18 years old or older.

Exclusion Criteria

My shoulder X-rays show arthritis.

You are pregnant, cannot read, or do not speak English.

I have a nerve condition affecting my shoulder movement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Assessment

Patient demographics collected and pain/functional status assessed using VAS, SST, ASES, and PROMIS-29 scores

1 day

1 visit (in-person)

Surgery and Immediate Post-operative Care

Patients undergo either partial rotator cuff repair alone or with SCR; intraoperative data collected

1 day

1 visit (in-person)

Post-operative Follow-up

Patients follow-up in clinic at 6 weeks, 3, 6, 12, and 24 months post-operatively; questionnaires administered and complications assessed

24 months

5 visits (in-person)

Follow-up MRI Assessment

MRI performed at 12-month follow-up to assess repair integrity

1 day

1 visit (in-person)

Treatment Details

Interventions

• Partial Rotator Cuff Repair
• Superior Capsular Reconstruction

Trial Overview The study compares two surgical treatments for serious rotator cuff injuries: partial rotator cuff repair alone versus the same repair with superior capsule reconstruction (SCR). Pain and function will be measured at multiple times post-surgery to see which method works better. The trial will also use MRI to check how often each treatment fails after one year.

Participant Groups

Group I: Superior Capsular Reconstruction Active Control 1 Intervention

Group II: Partial Rotator Cuff Repair Placebo Group 1 Intervention

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

Approved in United States as Partial Rotator Cuff Repair for:

• Irreparable rotator cuff tears
• Shoulder instability
• Rotator cuff dysfunction

Approved in European Union as Partial Rotator Cuff Repair for:

• Massive rotator cuff tears
• Shoulder pain
• Limited shoulder mobility

Approved in Canada as Partial Rotator Cuff Repair for:

• Rotator cuff injuries
• Shoulder joint instability
• Chronic shoulder pain

Who Is Running the Clinical Trial?

Robert J. Gillespie

Lead Sponsor

Trials

1

Recruited

110+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Midwest Orthopaedics at Rush

Collaborator

Trials

3

Recruited

160+

Lake Health

Collaborator

Trials

1

Recruited

110+

Findings from Research

Partial rotator cuff repair can be a viable option for patients with irreparable rotator cuff tears, aiming to stabilize the shoulder joint by restoring the rotator cable complex.

This technical note introduces a new suture-based cable reconstruction method for partial repairs, which may offer an alternative to traditional reattachment techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Technique for a Suture-Based Cable Reconstruction of an Irreparable Posterosuperior Rotator Cuff Tear. Adams, CR., Pasqualini, I., Heidenthal, JM., et al.[2022]

The article introduces a modified technique for arthroscopic partial reconstruction of the superior capsule using the long head of the biceps tendon, which may offer a simpler alternative to more complex surgeries for massive rotator cuff tears.

This technique aims to reduce the frequency of rotator cuff retears, which are common with traditional partial repairs, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

L-Shape Superior Capsular Augmentation Technique Using Biceps Tendon: The Biceps L-Shape Shifting Technique. Kim, DS., Yeom, J., Park, J., et al.[2020]

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 48 patients with rotator cuff tears, a limited open surgical technique combining partial acromioplasty and rotator cuff repair resulted in significant improvement in shoulder function, as indicated by an increase in the Constant-Murley shoulder score from an average of 44 pre-surgery to 88 post-surgery over a follow-up period of 38 months.

The procedure demonstrated a good safety profile, with only 2% of patients experiencing suture displacement and 4% having impingement due to granulation tissue, suggesting that minimal acromioplasty is a viable treatment option for rotator cuff tears associated with subacromial impingement syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of limited open rotator cuff repair with partial acromioplasty for rotator cuff tears with subacromial impingement syndrome]. Orhun, H., Gürkan, V., Dursun, M., et al.[2016]

Arthroscopic partial repair of irreparable rotator cuff tears, particularly when the supraspinatus is irreparable but the infraspinatus can be repaired, leads to significant functional improvement over an average follow-up of 7 years, with the Constant and Murley score increasing from 39.1 to 76.3 (P < .001).

The study found that while overall outcomes were positive, female and older patients tended to have lower functional results, indicating that demographic factors may influence recovery after this surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life and Functional Results of Arthroscopic Partial Repair of Irreparable Rotator Cuff Tears. Galasso, O., Riccelli, DA., De Gori, M., et al.[2018]

In a study of seven patients with massive rotator cuff tears, the technique of superior capsular reconstruction (SCR) combined with partial cuff repair led to significant improvements in shoulder function and pain relief over 12 months, with average increases in Constant score (12.1 points) and UCLA score (9.4 points).

All patients demonstrated improved active forward flexion (average increase of 40 degrees) and a reduction in pain (average decrease of 5.1 points on the Numerical Pain Rating Scale), indicating that SCR can be an effective option even for complex cases of irreparable rotator cuff tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvaging the 'irreparable' tear: Superior Capsular Reconstruction augmented with partial cuff repair. Wong, SJ., Neo Jun Hao, B., Marian Lie, H., et al.[2023]

In a study of 65 patients with large to massive rotator cuff tears, the arthroscopic hybrid repair technique showed significant improvements in pain and function scores after 2 years compared to preoperative levels, indicating its efficacy as a treatment option.

The hybrid repair technique resulted in better clinical outcomes than partial repair, although 20% of patients experienced re-tears, suggesting that while hybrid repair is promising, there is still a risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Incomplete Repair Using a "Hybrid Technique" for Large to Massive Rotator Cuff Tears: Clinical Results and Structural Integrity. Jeong, JY., Yoon, YC., Lee, SM., 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 technique for addressing large to massive rotator cuff tears, helping to maintain shoulder joint stability and prevent further deterioration into cuff tear arthropathy.

The article details an innovative approach called arthroscopic in situ superior capsular reconstruction, which utilizes the long head of the biceps tendon, offering a new option for patients with challenging rotator cuff injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic In Situ Superior Capsular Reconstruction Using the Long Head of the Biceps Tendon. Kim, YS., Lee, HJ., Park, I., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A Technique for a Suture-Based Cable Reconstruction of an Irreparable Posterosuperior Rotator Cuff Tear. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

L-Shape Superior Capsular Augmentation Technique Using Biceps Tendon: The Biceps L-Shape Shifting Technique. [2020]

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

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

4. Turkey pubmed.ncbi.nlm.nih.gov

[Results of limited open rotator cuff repair with partial acromioplasty for rotator cuff tears with subacromial impingement syndrome]. [2016]

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

Quality of Life and Functional Results of Arthroscopic Partial Repair of Irreparable Rotator Cuff Tears. [2018]

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

Salvaging the 'irreparable' tear: Superior Capsular Reconstruction augmented with partial cuff repair. [2023]

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

Arthroscopic Incomplete Repair Using a "Hybrid Technique" for Large to Massive Rotator Cuff Tears: Clinical Results and Structural Integrity. [2019]

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

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

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

Arthroscopic In Situ Superior Capsular Reconstruction Using the Long Head of the Biceps Tendon. [2022]