NCT05395819 Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis
| NCT ID | NCT05395819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Shoulder Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-05-30 |
| Primary Completion | 2026-05-30 |
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 40 participants in total. It began in 2022-05-30 with a primary completion date of 2026-05-30.
⚠ 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
Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide and it is common in an aging population. Surgical shoulder replacement (arthroplasty) is typically considered when non-surgical measures, such as physiotherapy or medication, have failed. There are two commonly performed surgical replacement procedures in patients who have advanced shoulder OA, and are 65 years of age and older: "Total Shoulder replacement or Arthroplasty (TSA)" and "Reverse Total Shoulder Arthroplasty (RTSA)". Few studies have compared the two procedures. Surgeons face uncertainty regarding which procedure to perform in patients 65 years of age and older. This pilot Randomized Controlled Trial (RCT) will compare the "TSA" and "RTSA" procedures, in patients 65 years of age and older. Participants will be assigned at random, (like flipping a coin), to one of the two groups (TSA or RTSA). The overall goal of this pilot study is to determine which procedure produces better functional and quality of life outcomes with fewer complications within the first 12-months after surgery. Moreover, pilot data will help determining the feasibility of conducting a larger trial comparing TSA versus RTSA surgical management in 65 years of age and older participants with advanced shoulder OA.
Eligibility Criteria
Inclusion Criteria: 1. Patients who have failed standard non-surgical management of their shoulder osteoarthritis who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as: 1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs 2. Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.) 3. Activity modification 2. Imaging, and intra-operative findings confirming advanced gleno-humeral cartilage loss 3. Patients may present with a glenoid deficiency and \>15 degrees of retroversion 4. 65 years of age and older Exclusion Criteria: 1. Active joint or systemic infection 2. Rotator cuff arthropathy 3. Need for an augmented glenoid component or a bone graft to correct version to within 10 degrees of neutral 4. Retroversion cannot be surgically corrected to within 10 degrees of neutral with a "high- side" ream technique 5. Significant muscle paralysis 6. Charcot's arthropathy 7. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk) 8. Active Workers Compensation Board (WCB) claim 9. Unable to understand the consent form/process 10. Psychiatric illness that precludes informed consent 11. Unwilling to be followed for the duration of the study 12. History of previous shoulder surgery on affected side
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05395819 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Shoulder Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05395819 currently recruiting?
Yes, NCT05395819 is actively recruiting participants. Contact the research team at Ailar.Ramadi@albertahealthservices.ca for enrollment information.
Where is the NCT05395819 trial being conducted?
This trial is being conducted at Edmonton, Canada, Edmonton, Canada, Edmonton, Canada, Edmonton, Canada and 4 additional locations.
Who is sponsoring the NCT05395819 clinical trial?
NCT05395819 is sponsored by University of Alberta. The trial plans to enroll 40 participants.