NCT04629391 Anatomic TSA vs RTSA for Glenohumeral Arthritis
| NCT ID | NCT04629391 |
| Status | Recruiting |
| Phase | — |
| Sponsor | La Tour Hospital |
| Condition | Arthritis Shoulder |
| Study Type | INTERVENTIONAL |
| Enrollment | 296 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 296 participants in total. It began in 2020-09-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion. The primary goal of our prospective randomized study is to determine whether RTSA have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.
Eligibility Criteria
Inclusion Criteria: * Primary glenohumeral arthritis, * Intact rotator cuff, * No important glenoid bone loss (cf exclusion criteria), * Patients between 65 and 85 years old * Informed Consent as documented by signature (Appendix Informed Consent Form). Exclusion Criteria: * B2 glenoid with \> 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion, * B3 and C type glenoids, * Full thickness rotator cuff tear, * Acute or malunited proximal humeral fracture, * Chronic locked dislocation * Rheumatoid arthritis, * Revision surgery or surgical antecedents, * Tumors, * Axillary nerve damage, * Non-functioning deltoid muscle, * Glenoid vault deficiency precluding baseplate fixation, * Infection and neuropathic joints, * Known or suspected non-compliance, drug or alcohol abuse, * Patients incapable of judgement or under tutelage, * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant, * Enrolment of the investigator, his/her family members, employees and other dependent persons.
Contact & Investigator
Alexandre Lädermann, MD
PRINCIPAL INVESTIGATOR
La Tour Hospital
Frequently Asked Questions
Who can join the NCT04629391 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 85 Years, studying Arthritis Shoulder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04629391 currently recruiting?
Yes, NCT04629391 is actively recruiting participants. Contact the research team at alexandre.laedermann@gmail.com for enrollment information.
Where is the NCT04629391 trial being conducted?
This trial is being conducted at Meyrin, Switzerland.
Who is sponsoring the NCT04629391 clinical trial?
NCT04629391 is sponsored by La Tour Hospital. The principal investigator is Alexandre Lädermann, MD at La Tour Hospital. The trial plans to enroll 296 participants.