BridgeMD
Compares treatment options for Arthritis Shoulder
Official title Anatomic TSA vs RTSA for Glenohumeral Arthritis
ClinicalTrials.gov ID: NCT04629391
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 85
You may be able to join if
- Primary glenohumeral arthritis,
- Intact rotator cuff,
- No important glenoid bone loss (cf
You likely can't join if
- 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,
See the full eligibility criteria
- Primary glenohumeral arthritis,
- Intact rotator cuff,
- No important glenoid bone loss (cf
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Meyrin, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Meyrin, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.