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Comparison between rotator cuff repair with muscle advancement and extreme medialized rotator cuff repair for massive rotator cuff tears

A Prospective Randomized Non-Inferiority Trial Comparing Rotator Cuff Repair with Muscle Advancement Versus Extreme Medialized Repair in the Treatment of Massive Rotator Cuff Tears

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011138
Enrollment
60
Registered
2025-11-11
Start date
2025-11-17
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : This randomized, single-center clinical trial enrolls patients with massive rotator cuff tears to compare the clinical effectiveness of two surgical interventions: extreme medializ
however, excessive medialization may reduce the abduction moment arm and potentially impair function. In Group 2, muscle advancement (MA) repair was initially described as an open procedure by Debeyr
nonetheless, high-quality randomized comparative trials and long-term follow-up data remain limited.

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Persistent symptoms despite =3 months of conservative treatment. MRI evidence of either (a) a posterosuperior rotator cuff tear =3 cm; or (b) a posterosuperior rotator cuff tear =2.5 cm with a repairable subscapularis tear, for which surgery is indicated, and in whom a tension-free anatomic repair cannot be achieved with standard rotator cuff repair alone. Intact deltoid function (no deltoid dysfunction).

Exclusion criteria

Exclusion criteria: Prior surgery on the ipsilateral shoulder. History of ipsilateral shoulder arthritis or prior treatment for infection in the ipsilateral shoulder. Full-thickness articular cartilage loss on MRI (glenohumeral joint). Acute, trauma-related rotator cuff tear. Inability to comply with =1 year of outpatient follow-up. Pregnant or likely to become pregnant during the study period. Pain =3 on the visual analogue scale (VAS) in the contralateral (non-operative) shoulder. Autoimmune disease or HIV antibody–positive status. Declines to provide informed consent. Unable to communicate in Korean such that informed consent cannot be obtained. Currently participating in another clinical trial. Psychiatric illness, risk of dementia, or any other condition deemed by the investigators to make the patient unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
Constant-Murley score.

Secondary

MeasureTime frame
Visual Analog Scale (VAS) for pain;operative time;Range of motion;ASES (American Shoulder and Elbow Surgeons score);Ultrasonography;MRI (Magnetic Resonance Imaging)

Countries

Korea, Republic of

Contacts

Public ContactHYUNG JUN KOO

Seoul National University Hospital

kgudwns24@naver.com+82-2-2072-2368

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026