Comparison of Shoulder Arthroplasty Techniques in the Treatment of Glenohumeral Osteoarthritis: Protocol

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

Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can produce pain and dysfunction at the affected joint and is a growing occurrence in an aging population. Total shoulder arthroplasty (TSA) is a surgical treatment used to treat patients with shoulder OA which involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent particularly when the arthritis is associated with bone erosion on the glenoid (socket). Given the high rate of revisions associated with TSA treatment in the setting of glenoid bone erosion, a number of surgical strategies have been developed. These surgical techniques include eccentric reaming which involves removing bone from the front of the socket, augmented glenoid component implantation, and posterior bone grafting to compensate for glenoid bone loss, and reverse shoulder arthroplasty. Few research studies have compared these different surgical techniques to one another. Previous studies have been limited to case series with small sample sizes and respective designs. This study is being conducted to determine which approach produces better outcomes. For the purpose of this study we will be comparing total shoulder arthroplasty techniques a) augmented glenoid component and eccentric reaming and b) augmented glenoid component and bone grafting in participants with advanced glenohumeral osteoarthritis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ 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

• Patients will present with a glenoid retroversion between 10-26 degrees.

• Imaging, and intra-operative findings confirming advanced humeral head cartilage loss, with or without glenoid cartilage loss.

• Age 18 years or older

Locations
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Contact Information
Primary
Peter Lapner, MD
plapner@toh.ca
613-737-8899
Backup
Katie McIlquham
613-737-8899
Time Frame
Start Date: 2017-04-23
Estimated Completion Date: 2028-12
Participants
Target number of participants: 216
Treatments
Active_comparator: Participants with 10-15 degrees of glenoid retroversion
Active_comparator: Participants with >15 degrees of glenoid retroversion
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov