Reverse Total Shoulder ArthroplastyI-CORENCT07604714
Reverse Total Shoulder Arthroplasty With or Without Partial Coracoidectomy: Evaluation of Functional Internal Rotation
A study testing Reverse total shoulder arthroplasty with coracoidectomy and Reverse total shoulder arthroplasty without coracoidectomy in people with Reverse Total Shoulder Arthroplasty, run by Clinique Générale dAnnecy at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reverse Total Shoulder Arthroplasty
- What is being tested?
- Reverse total shoulder arthroplasty with coracoidectomy and Reverse total shoulder arthroplasty without coracoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2026to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnant women, women in labor, or breastfeeding women
- Patients receiving psychiatric care
- Patients not enrolled in a social security program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Générale d'Annecy
Annecy, 74000
CLINIQUE GENERALE (CLINIQUE GENERALE ANNECY VIVALTO SANTE) CGA BUIJZE GA, 0669962733, gabuijze@hotmail.com
About this study
Official title: Reverse Total Shoulder Arthroplasty With or Without Partial Coracoidectomy: a Randomized Controlled Trial Evaluating 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.
- Conditions
- Reverse Total Shoulder Arthroplasty
- Being tested
- Reverse total shoulder arthroplasty with coracoidectomy, Reverse total shoulder arthroplasty without coracoidectomy
- Keywords
- reverse total shoulder arthroplasty, ADLIR (Activities of Daily Living requiring Internal Rotation), functional internal rotation, coracoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse total shoulder arthroplasty with coracoidectomyProcedure or surgery
Reverse total shoulder arthroplasty with coracoidectomy
Reverse total shoulder arthroplasty without coracoidectomyProcedure or surgery
Reverse total shoulder arthroplasty without coracoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Reverse total shoulder arthroplasty without coracoidectomy | Sham comparator | Not described Receives: Procedure: Reverse total shoulder arthroplasty without coracoidectomy |
| Reverse total shoulder arthroplasty with coracoidectomy | Experimental | Not described Receives: Procedure: Reverse total shoulder arthroplasty with coracoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of functional internal rotation, as measured by the change in the ADLIR (Activities of Daily Living requiring Internal Rotation) score
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.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start16 Jun 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Générale dAnnecy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604714
- Sponsor's protocol ID
- 2026-11-CGA
- Acronym
- I-CORE
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Total Shoulder Arthroplasty With or Without Partial Coracoidectomy: a Randomized Controlled Trial Evaluating Functional Internal Rotation
- ClinicalTrials.gov ID
- NCT07604714
- Acronym / sponsor ID
- I-CORE / 2026-11-CGA
- Conditions
- Reverse Total Shoulder Arthroplasty
- Keywords
- reverse total shoulder arthroplasty, ADLIR (Activities of Daily Living requiring Internal Rotation), functional internal rotation, coracoidectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinique Générale dAnnecyUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reverse total shoulder arthroplasty with coracoidectomyReverse total shoulder arthroplasty with coracoidectomy | Procedure or surgery | Reverse total shoulder arthroplasty with coracoidectomy |
| Reverse total shoulder arthroplasty without coracoidectomyReverse total shoulder arthroplasty without coracoidectomy | Procedure or surgery | Reverse total shoulder arthroplasty without coracoidectomy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse total shoulder arthroplasty with coracoidectomy and Reverse total shoulder arthroplasty without coracoidectomy in people with Reverse Total Shoulder Arthroplasty, run by Clinique Générale dAnnecy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.