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NCT Number: NCT07604714

Reverse Total Shoulder Arthroplasty With or Without Partial Coracoidectomy: Evaluation of Functional Internal Rotation

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Générale d'Annecy

Annecy, 74000, France

Location status: Recruiting

Location contact

CLINIQUE GENERALE (CLINIQUE GENERALE ANNECY VIVALTO SANTE) CGA BUIJZE GA

CONTACT

[email protected]

0669962733

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Reverse total shoulder arthroplasty with coracoidectomy

Procedure

Reverse total shoulder arthroplasty with coracoidectomy

Reverse total shoulder arthroplasty without coracoidectomy

Procedure

Reverse total shoulder arthroplasty without coracoidectomy

Primary outcomes

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

    Time frame: 12 months after surgery

    A maximum score of 100 indicates that the patient experiences no discomfort in daily life due to limited internal rotation. A minimum score of 14 indicates severe functional impairment due to limited internal rotation.

Sponsors and collaborators

Lead sponsor

Clinique Générale dAnnecy

Other

Registry information

Official study title

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

Acronym: I-CORE

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 22, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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