RSA Vs RCR for Massive RCTs

NCT05807854 | Recruiting FDA Device

• 1 other identifier: 2023-00111
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 2

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).

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeon (ASES) score

  American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).

  At 24 post-operative months

Secondary Outcomes (15)

• Pain on Visual Analogue Scale (pVAS)

  At 24 post-operative months

• Constant score

  At 24 post-operative months

• Single Assessment Numeric Evaluation (SANE)

  At 24 post-operative months

• Complication

  Within the 24 post-operative months

• Location of the defect

  At 24 post-operative months

Study Arms (2)

Arthroscopic surgery

ACTIVE COMPARATOR

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

Procedure: Arthroscopy

Reverse shoulder arthroplasty

EXPERIMENTAL

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).

Device: Reverse Shoulder Arthroplasty

Interventions

Arthroscopy PROCEDURE

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

Arthroscopic surgery

Reverse Shoulder Arthroplasty DEVICE

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

Reverse shoulder arthroplasty

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient voluntarily consents to participate
• Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment
• 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

You may not qualify if:

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

Sponsors & Collaborators

• La Tour Hospital: lead

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

La Tour hospital

Meyrin, Canton of Geneva, 1217, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 40759980 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• Alexandre Lädermann, MD

  La Tour hospital, Meyrin (1217) Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

• Patrick Denard, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Lädermann, MD

CONTACT

+41 22 71 975 55; alexandre.laedermann@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician will be blinded to patient allocation groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon FMH, Shoulder and Elbow Surgery Traumatology

Model Details: Multicenter, Randomized Comparative Surgical Trial

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

CH (1); US (1)