RecruitingNot Applicable

Anatomic TSA vs RTSA for Glenohumeral Arthritis

Switzerland296 participantsStarted 2020-09-01

Plain-language 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.

Who can participate

Age range

65 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in American Shoulder and Elbow Surgeons score (ASES)

Timeframe: Between baseline and 2 postoperative years

Trial details

NCT IDNCT04629391

SponsorLa Tour Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Alexandre Lädermann, MD

+41 22 719 75 55 alexandre.laedermann@gmail.com

View on ClinicalTrials.gov More Arthritis Shoulder trials