Surgical techniques for shoulder osteoarthritis treatment

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

This study is testing different surgical methods for treating shoulder osteoarthritis to see which one helps patients feel better and improves their quality of life after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT02966886 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates different surgical techniques for treating osteoarthritis of the shoulder, specifically focusing on total shoulder arthroplasty (TSA). Patients with varying degrees of glenoid retroversion will be randomly assigned to receive either TSA with eccentric glenoid reaming, augmented glenoid component implantation, or posterior glenoid bone grafting. The primary objective is to assess patient outcomes using the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) score at multiple post-operative intervals. Secondary objectives include evaluating component survivorship and quality of life improvements through various assessment tools over a two-year period.

Who should consider this trial

Good fit: Ideal candidates are men and women of any age with advanced osteoarthritis of the glenohumeral joint who have not responded to standard non-surgical management.

Not a fit: Patients with mild osteoarthritis or those who have not yet attempted non-surgical management may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing shoulder arthroplasty.

How similar studies have performed: Other studies have shown promising results with similar surgical approaches, indicating potential for success in this trial.

Eligibility criteria

Patient Population The target population is both men and women of any age with advanced osteoarthritis of the glenohumeral joint who are considered by the treating surgeon to be a candidate for shoulder replacement. The type of arthritic process will not be considered a deciding factor. The arthritis must be amenable to treatment using either a humeral head replacement (stemmed or stem-less), or a standard total shoulder replacement.

Inclusion Criteria

1. 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:

   1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
   2. Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
   3. Activity modification
2. Patients will present with a glenoid retroversion between 10-26 degrees.
3. Imaging, and intra-operative findings confirming advanced humeral head cartilage loss, with or without glenoid cartilage loss.
4. Age 18 years or older

Exclusion Criteria

1. \< 10 degrees / \> 27 degrees of glenoid retroversion
2. Active joint or systemic infection
3. Rotator cuff arthropathy
4. Significant muscle paralysis
5. Charcot's arthropathy
6. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
7. Unable to understand the consent form/process
8. Pregnancy
9. Psychiatric illness that precludes informed consent
10. Unwilling to be followed for the duration of the study
11. Retroversion cannot be surgically corrected to within 10 degrees of neutral
12. History of previous shoulder surgery on affected side
13. Rheumatoid arthritis in the affected shoulder

Where this trial is running

Ottawa, Ontario

• The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Peter Lapner, MD — The Ottawa Hospital
• Study coordinator: Peter Lapner, MD

Conditions Osteoarthritis, Shoulder; Surgical Management