Reverse Total Shoulder Arthroplasty With or Without Partial Coracoidectomy: a Randomized Controlled Trial Evaluating Functional Internal Rotation

NCT07604714 | Not Yet Recruiting

• 1 other identifier: 2026-11-CGA
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project aims to conduct a randomized controlled trial comparing the functional outcomes and complications of standard reverse total shoulder arthroplasty and reverse total shoulder arthroplasty combined with partial coracoidectomy. The study will assess functional internal rotation at 12 months post-surgery, as measured by the ADLIR (Activities of Daily Living requiring Internal Rotation) score.

Conditions

Reverse Total Shoulder Arthroplasty

Keywords

reverse total shoulder arthroplasty; ADLIR (Activities of Daily Living requiring Internal Rotation); functional internal rotation; coracoidectomy

Outcome Measures

Primary Outcomes (1)

• Assessment of functional internal rotation, as measured by the change in the ADLIR (Activities of Daily Living requiring Internal Rotation) score

  12 months after surgery

Study Arms (2)

Reverse total shoulder arthroplasty without coracoidectomy

SHAM COMPARATOR

Procedure: Reverse total shoulder arthroplasty without coracoidectomy

Reverse total shoulder arthroplasty with coracoidectomy

EXPERIMENTAL

Procedure: Reverse total shoulder arthroplasty with coracoidectomy

Interventions

Reverse total shoulder arthroplasty with coracoidectomy PROCEDURE

Reverse total shoulder arthroplasty with coracoidectomy

Reverse total shoulder arthroplasty with coracoidectomy

Reverse total shoulder arthroplasty without coracoidectomy PROCEDURE

Reverse total shoulder arthroplasty without coracoidectomy

Reverse total shoulder arthroplasty without coracoidectomy

Eligibility Criteria

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

You may qualify if:

• \- Adults undergoing reverse total shoulder arthroplasty (rTSA), including primary procedures or fracture repair. Indications may include arthropathy due to a rotator cuff tear, primary glenohumeral osteoarthritis with an irreparable rotator cuff tear, or post-traumatic arthritis.

You may not qualify if:

• Patients with a history of coracoid fractures or who have previously undergone surgery involving the coracoid process.
• Patients undergoing latissimus dorsi transfers
• Presence of an active infection, inflammatory arthritis, or a tumor affecting the shoulder region.
• Patients with pre-existing neuromuscular disorders affecting shoulder function
• Patients who are unwilling or unable to participate in the trial or complete follow-up assessments
• Patients deprived of their liberty by judicial or administrative order, in pretrial detention, or under guardianship, conservatorship, or judicial protection.
• Pregnant women, women in labor, or breastfeeding women
• Patients receiving psychiatric care
• Patients not enrolled in a social security program

Sponsors & Collaborators

• Clinique Générale dAnnecy: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05