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

Recruiting at 2 trial 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two surgical methods for treating severe rotator cuff tears that cannot be fully repaired. One method involves a partial rotator cuff repair, while the other includes a procedure called superior capsular reconstruction. The goal is to determine which method more effectively reduces pain and improves shoulder function. Individuals with shoulder issues that hinder daily tasks and have been informed that their rotator cuff tear cannot be fully repaired may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for challenging shoulder conditions.

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

Research shows that both surgical treatments compared in this trial—Partial Rotator Cuff Repair and Superior Capsular Reconstruction (SCR)—are generally safe. For SCR, studies have shown significant improvements in shoulder function and pain reduction. One study followed 23 patients for up to 51 months and found excellent results in pain relief and shoulder movement. Several studies have also reported improvements in shoulder mobility. Overall, SCR appears to be well-tolerated.

Partial Rotator Cuff Repair, a more traditional method, is commonly performed and considered safe. It has been used for many years to address shoulder problems. Although detailed information on side effects is less frequently discussed, its long-standing use suggests general safety.

While no treatment is without risk, current evidence indicates that both procedures are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for rotator cuff tears because they offer alternatives to traditional methods like complete rotator cuff repair or non-surgical options. Partial Rotator Cuff Repair focuses on repairing only the damaged portion of the tendon, which could potentially lead to faster recovery times and less post-operative stiffness compared to more extensive repairs. Meanwhile, Superior Capsular Reconstruction is a technique that uses a graft to stabilize the shoulder and restore function, which might offer a solution for patients with irreparable tears who have limited treatment options. Both approaches aim to improve shoulder function and reduce pain while minimizing the invasiveness of the procedure.

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

This trial will compare Partial Rotator Cuff Repair with Superior Capsular Reconstruction (SCR) for treating rotator cuff tears. Research has shown that SCR effectively treats severe rotator cuff tears that cannot be repaired. Studies have found that SCR not only reduces pain but also improves shoulder function and range of motion. Specifically, one study found that patients who underwent SCR recovered better shoulder movement and function compared to those who only had partial repairs. Additionally, SCR has maintained positive results over the long term. These findings suggest that SCR could be a promising option for those with serious rotator cuff problems. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39741480/

Long-term Clinical and Structural Outcomes of Arthroscopic ...

Arthroscopic SCR using fascia lata autograft is an effective surgical option for irreparable rotator cuff tears and retains positive outcomes for at least 10 ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2214687325000159

Comparison of clinical outcomes of superior capsular ...

Although both procedures effectively reduced pain and improved functional scores, SCR demonstrated superior recovery of active ROM and overall shoulder function ...

3.

jshoulderelbow.org

jshoulderelbow.org/article/S1058-2746(24)00778-X/fulltext

Combined cuff repair and superior capsular reconstruction ...

This study shows the short-term results on a combination technique to treat rotator cuff tears which are irreparable, have a high risk of retear ...

4.

jbjs.org

jbjs.org/reader.php?rsuite_id=2058072

Superior Capsular Reconstruction for Massive Rotator Cuff ...

Long-term outcome data are essential to determine the role of superior capsular reconstruction for young patients with massive irreparable rotator cuff tears.

5.

jisakos.com

jisakos.com/article/S2059-7754(23)00522-9/fulltext

Early clinical and patient-reported outcomes for ...

This study confirmed that SCR improves pain and ROM in the short term. Mini-open SCR appears to provide similar improvements in pain and ROM compared with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9791834/

The Number of Surgeons Using Superior Capsular ...

A total of 4% of surgeons who reported using the SCR technique used SCR in greater than 90% of their irreparable RCR cases, as compared with 38% ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666061X22000633

Arthroscopic Superior Capsular Reconstruction for Massive ...

ASCR contributes to significant improvements in patient-reported clinical outcomes and ROM at follow-up after a mean of more than two years.

8.

arthrex.com

arthrex.com/shoulder/superior-capsule-reconstruction-technique

Superior Capsular Reconstruction (SCR) Technique

In the SCR study, a 24- to 51-month follow-up on 23 patients shows outstanding outcomes in pain, ASES scores, and acromiohumeral distance measurements.1 The SCR ...