RSA Vs RCR for Massive RCTs

Part of paid clinical trials in Portland, Oregon.

Sponsor
La Tour Hospital
Study ID
NCT05807854
Status
Recruiting
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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Arthroscopy — PROCEDURE
    The surgeon reattaches the torn tendon to the bone with anchors and sutures.
  • Reverse Shoulder Arthroplasty — DEVICE
    It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).

Study Details

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).

Key Dates

Start date
Mar 1, 2023
Status verified
Oct 2024
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Patrick Denard, MD

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By research site
Oregon Health & Science University· Portland, OR

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