Study Evaluating Reverse Versus Anatomic Total Shoulder Arthroplasty in Shoulders With Greater Than 15 Degrees of Retroversion in the Treatment of Osteoarthritis: Protocol

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will compare total shoulder arthroplasty (TSA) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a prospective, randomized controlled trial to determine the optimal treatment in this patient population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Diagnosis of idiopathic shoulder OA.

• Patients who have failed standard non-surgical management of their shoulder OA 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 at least 6 months. Medical management will be defined as: a) The use of drugs including analgesics and nonsteroidal anti-inflammatory drugs, b) Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.), c) Activity modification

• Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss

• Patients with a glenoid deficiency and \>15 degrees of glenoid retroversion up to a maximum of 26 degrees of glenoid retroversion (i.e. -15.1, -17, -20…etc.)

• 65 years of age and older

Locations
Other Locations
Canada
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Contact Information
Primary
Katie McIlquham
kmcilquham@ohri.ca
613-737-8899
Time Frame
Start Date: 2022-08-09
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 108
Treatments
Active_comparator: Total Shoulder Arthroplasty (anatomic) + augmented glenoid component
TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. An additional surgical technique, augmented glenoid component implantation is performed when there is missing bone in the shoulder and is currently being done as standard of care. This technique is used particularly when a large amount of instability within the shoulder joint is present. This technique attempts to realign and restore balance to the shoulder joint using artificial components.
Active_comparator: Reverse Shoulder Arthroplasty
RSA procedure is similar to a TSA, however the orientation of the ball and socket joint is placed in the reverse position
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov