RSA Vs RCR for Massive RCTs

NCT ID: NCT05807854

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2027-03-01

Brief Summary

Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).

Detailed Description

The majority of degenerative rotator cuff tears occur in individuals over 60 years of age. Therefore, as our population increases in size and advances in age, the incidence of rotator cuff tears is also increasing. A growing number of people are remaining active at this age, and continue to place substantial physical demands on their shoulders notably into their seventh and eighth decades of life. At the same time, the rotator cuff undergoes intrinsic degeneration and the prevalence of osteoporosis increases. Consequently, a significant and growing number of arthroscopic rotator cuff repairs are performed in individuals with poor soft tissue or bone quality. Moreover, whereas most rotator cuff tears occur at the tendon-bone insertion, fixation quality can be challenged by a tear that occurs more medially, leaving only a small amount of tendon for fixation by suture.

Different treatment options are available for massive or irreparable rotator cuff tears, including debridement and subacromial decompression, repair (partial or complete), transfer of the subscapularis tendon, transfer of the teres major muscle, deltoid flap reconstruction, transfer of the latissimus dorsi or the pectoralis major, superior capsule reconstruction, augmented cuff repair, subacromial balloon and reverse total shoulder replacements. None of these treatments has proved superiority on other ones, particularly when the rotator cuff is massively torn.

Massive degenerative rotator ruff tears are a challenge. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. Recently, Liu et al. demonstrated that both rotator cuff repair (RCR) and reverse shoulder arthroplasty (RSA) are effective and reliable options for massive rotator cuff tears (RCT), but revealed a better shoulder function for patients in the rotator cuff repair (RCR) group. While these results are interesting, this study remains retrospective and call for new studies with a higher level of evidence.

The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arthroscopic surgery

The massive degenerative rotator cuff tear are treated by arthroscopy. It consists in reattaching the torn tendon with anchors and sutures.

Group Type: ACTIVE_COMPARATOR

Arthroscopy

Intervention Type: PROCEDURE

The surgeon reattaches the torn tendon to the bone with anchors and sutures.

Reverse shoulder arthroplasty

The problems induced by the massive degenerative rotator cuff tear are solved by a complete replacement of the shoulder joint with a prosthesis (reverse design).

Group Type: EXPERIMENTAL

Reverse Shoulder Arthroplasty

Intervention Type: DEVICE

It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).

Interventions

Arthroscopy

The surgeon reattaches the torn tendon to the bone with anchors and sutures.

Intervention Type: PROCEDURE

Reverse Shoulder Arthroplasty

It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1 Patient voluntarily consents to participate
• 2 Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment
• 3 Patients with the following pre-operative images: Three standardized X-rays series and Magnetic Resonance Imaging (MRI) or arthro Magnetic Resonance Imaging without sign of traumatic lesions

Exclusion Criteria

• 1 Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study
• 2 Revision rotator cuff repair
• 3 Patient consent withdrawal
• 4 Glenohumeral arthritis defined as stage > 3 Hamada classification
• 5 Infection and neuropathic joints
• 6 Known or suspected non-compliance, drug or alcohol abuse
• 7 Patients incapable of judgement or under tutelage
• 8 Inability to follow the procedures of the study
• 9 Enrolment of the investigator, his/her family members, employees and other dependent persons

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

La Tour Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Alexandre Lädermann

Orthopaedic Surgeon FMH, Shoulder and Elbow Surgery Traumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Lädermann, MD

Role: PRINCIPAL_INVESTIGATOR

La Tour hospital, Meyrin (1217) Geneva, Switzerland

Patrick Denard, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA

Locations

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

La Tour hospital

Meyrin, Canton of Geneva, Switzerland

Site Status: RECRUITING

Countries

United States; Switzerland

Central Contacts

Alexandre Lädermann, MD

Role: CONTACT

alexandre.laedermann@gmail.com

+41 22 71 975 55

Facility Contacts

Patrick Denard, MD

Role: primary

Alexandre Lädermann, MD

Role: primary

alexandre.laedermann@gmail.com

+41 22 719 75 55

References

Ladermann A, Pernoud A, Cochard B, Bothorel H. Treatment of degenerative massive rotator cuff tears: a study protocol for a randomized non-inferiority comparative surgical trial. Trials. 2025 Aug 4;26(1):270. doi: 10.1186/s13063-025-08990-9.

Reference Type: DERIVED

PMID: 40759980 (View on PubMed)

Other Identifiers

2023-00111

Identifier Type: -

Identifier Source: org_study_id