Anatomic TSA vs RTSA for Glenohumeral Arthritis
Recruiting · NCT04629391 · Interventional (participants receive a specific treatment) · Lead sponsor: La Tour Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Total shoulder arthroplasty
What this trial is about
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 take part
Age range
65 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- La Tour Hospital - Meyrin, Switzerland