Recruiting

RSA vs. RCR

Sponsor:

La Tour Hospital

Code:

NCT05807854

Conditions

Rotator Cuff Tears

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Arthroscopy

Reverse Shoulder Arthroplasty

Study Details

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

Study ID

NCT05807854

Start date

Mar 1, 2023

Status verified date

Oct, 2024

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arthroscopic surgery

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

experimental: 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).

Interventions

Arthroscopy

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

Reverse Shoulder Arthroplasty

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

Primary outcome measure

  • American Shoulder and Elbow Surgeon (ASES) score [ Time Frame: At 24 post-operative months ]

Central Contacts and Locations

Central contacts

Alexandre Lädermann, MD

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

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

More Information

Sponsor

La Tour Hospital

Last update posted

Oct 26, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by La Tour Hospital on 2024-10-26.