Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID05395819

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

Led by University of Alberta · Updated on 2025-05-30

40

Participants Needed

8

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Alberta

Lead Sponsor

U

University Hospital Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are comparing two surgical procedures for patients aged 65 years and older who have advanced shoulder osteoarthritis (OA). The study aims to determine which surgery, Total Shoulder Arthroplasty (TSA) or Reverse Total Shoulder Arthroplasty (RTSA), leads to better functional outcomes and quality of life with fewer complications within the first year after surgery. This pilot randomized controlled trial will help decide the feasibility of a larger study to further assess these treatments. Participants will be randomly assigned to receive either TSA or RTSA surgery. The RTSA involves attaching a metal humeral component to the glenoid and a shallow glenoid component to the humerus, with surgical planning based on pre-operative CT scans. TSA replaces the arthritic humeral head with a metal component and the glenoid surface with a polyethylene component, also guided by CT-based templating. Both procedures aim to correct glenoid version within 10 degrees of neutral using standard surgical tools. After surgery, participants will have follow-up visits at 6 weeks, 3 months, 6 months, and 12 months. During these visits, researchers will measure shoulder range of motion, strength, and pain, and collect patient-reported quality of life and shoulder function questionnaires. They will also monitor for complications and medication use. The primary outcome is the change in the Western Ontario Osteoarthritis of the Shoulder (WOOS) score over 12 months. Secondary outcomes include re-operations, strength, range of motion, pain, and quality of life changes. The total study duration for each participant is 12 months post-surgery.

CONDITIONS

Brief Title

Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 65 years and older
  • Advanced shoulder osteoarthritis confirmed by imaging and surgery findings
  • Persistent pain and disability despite at least 6 months of non-surgical treatment including medication, physiotherapy, and activity modification
  • Patients who would benefit from shoulder arthroplasty
Not Eligible

You will not qualify if you...

  • Active joint or systemic infection
  • Rotator cuff arthropathy
  • Need for augmented glenoid component or bone graft to correct glenoid version
  • Retroversion that cannot be corrected to within 10 degrees of neutral with surgical technique
  • Significant muscle paralysis
  • Charcot's arthropathy
  • Major medical illness with life expectancy less than 1 year or high operative risk
  • Active Workers Compensation Board claim
  • Unable to understand consent process
  • Psychiatric illness preventing informed consent
  • Unwillingness to be followed for study duration
  • History of previous shoulder surgery on the affected side

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo either Total Shoulder Arthroplasty (TSA) or Reverse Total Shoulder Arthroplasty (RTSA) as per randomization.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 12 months post-surgery

Participants attend follow-up visits for assessments of shoulder range of motion, strength, clinical outcomes, and health-related quality of life questionnaires.

Visits at 6 weeks, 3 months, 6 months, and 12 months (in-person)

Trial Site Locations

Total: 8 locations

1

Royal Alexandra Hospital (Orthopaedic Surgical Centre)

Edmonton, Alberta, Canada, T5H 3V9

Actively Recruiting

2

Glen Sather Sports Medicine Clinic (University of Alberta)

Edmonton, Alberta, Canada, T6G 1Z1

Actively Recruiting

3

Kaye Edmonton Clinic

Edmonton, Alberta, Canada, T6G 1Z1

Actively Recruiting

4

Collaborative Orthopaedic Research (CORe), Clinical Sciences Building

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

5

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

6

Grey Nuns Community Hospital

Edmonton, Alberta, Canada, T6L 5X8

Actively Recruiting

7

Sturgeon Community Hospital

St. Albert, Alberta, Canada, T8N 6C4

Actively Recruiting

8

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

Loading map...

Research Team

A

Ailar Ramadi, PhD

L

Lauren Beaupre, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

AETOS Shoulder System Post Market Clinical Investigation

Shoulder Osteoarthritis

Actively Recruiting

5 locations

Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical P...

Shoulder Osteoarthritis

Actively Recruiting

1 location

Clinical Study of Myofascial Trigger Points Injection for Ch...

Myofascial Trigger Points

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Neck and shoulder pain in 70- to 79-year-old men and women: findings from the Health, Aging and Body Composition Study.

Molly T Vogt, Eleanor M Simonsick, Tamara B Harris...

https://pubmed.ncbi.nlm.nih.gov/14609687

Patterns of loosening of polyethylene keeled glenoid components after shoulder arthroplasty for primary osteoarthritis: results of a multicenter study with more than five years of follow-up.

Gilles Walch, Allan A Young, Pascal Boileau...

https://pubmed.ncbi.nlm.nih.gov/22258001