Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: A Pilot Randomized Control Trial

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
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

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

• Patients may present with a glenoid deficiency and \>15 degrees of retroversion

• 65 years of age and older

Locations
Other Locations
Canada
Collaborative Orthopaedic Research (CORe), Clinical Sciences Building
RECRUITING
Edmonton
Glen Sather Sports Medicine Clinic (University of Alberta)
RECRUITING
Edmonton
Grey Nuns Community Hospital
RECRUITING
Edmonton
Kaye Edmonton Clinic
RECRUITING
Edmonton
Royal Alexandra Hospital (Orthopaedic Surgical Centre)
RECRUITING
Edmonton
University of Alberta Hospital
RECRUITING
Edmonton
The Ottawa Hospital
RECRUITING
Ottawa
Sturgeon Community Hospital
RECRUITING
St. Albert
Contact Information
Primary
Ailar Ramadi, PhD
Ailar.Ramadi@albertahealthservices.ca
780-492-2398
Backup
Lauren Beaupre, PhD
lauren.beaupre@ahs.ca
780-492-8626
Time Frame
Start Date: 2022-05-30
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 40
Treatments
Experimental: Reverse Total Shoulder Arthroplasty (RTSA)
Patient will undergo a RTSA as per standard technique. It uses a stemmed metal humeral component attached to the glenoid and the shallow glenoid component attached to the humerus. Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric (high side) anterior reaming to within \< 10 degrees of neutral glenoid version. Standard instruments including a spherical burr and power reamers will be used to achieve this.
Active_comparator: Total Shoulder Arthroplasty (TSA)
Patients will undergo standard glenoid preparation and implantation of a TSA. It uses a stemmed metal humeral component to replace the arthritic head of humerus and a shallow polyethylene glenoid component to replace the arthritic glenoid surface. The degree of anterior- reaming will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Foundation, Canadian Orthopaedic Foundation
Leads: University of Alberta

This content was sourced from clinicaltrials.gov