Study Evaluating Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: Protocol

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will compare total shoulder arthroplasty (TSA) reverse shoulder arthroplasty (RSA) procedures, in the context of a prospective, randomized-controlled trial to determine the optimal treatment in patients 65 years of age and older, and equal to or less than 15 degrees of glenoid retroversion, who have glenohumeral osteoarthritis.

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

• Patients who have failed standard non-surgical management of their idiopathic 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:

‣ The use of drugs including analgesics and non-steroidal anti-inflammatory drugs

⁃ Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)

⁃ Activity modification

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

• Patients may present with a glenoid deficiency and \</=15 degrees of retroversion

• 65 years of age and older

Locations
Other Locations
Canada
University of Alberta
NOT_YET_RECRUITING
Edmonton
Kingston General Hospital (Site-Watkins 3)
RECRUITING
Kingston
The Ottawa Hospital
RECRUITING
Ottawa
Pan Am Clinic Foundation
NOT_YET_RECRUITING
Winnipeg
Contact Information
Primary
Peter Lapner Lapner, MD
plapner@toh.ca
613-737-8899
Backup
Katie McIlquham
kmcilquham@ohri.ca
613-737-8899
Time Frame
Start Date: 2020-03-09
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 108
Treatments
Active_comparator: Total Shoulder Arthroplasty (anatomic)
TSA procedure involves replacing the worn-out ball and socket joint with prosthetic 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