Surgical techniques for shoulder osteoarthritis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Peter Lapner, MD — The Ottawa Hospital
• Study coordinator: Peter Lapner, MD
• Email: plapner@toh.ca
• Phone: 613-737-8899

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Diaphragm-sparing regional anesthesia for shoulder surgery

  This study tests whether a suprascapular and infraclavicular nerve block can provide good shoulder surgery pain relief without causing diaphragm problems, compared with the standard interscalene block, in older adults.

  Recruiting Poznan University of Medical Sciences · Poznan · NCT07474896

• Lengthening a tendon to reduce shoulder pain after surgery

  This study is testing if lengthening a tendon during shoulder surgery can help reduce pain in patients one year after their operation.

  Recruiting Loyola University · Maywood, Illinois · NCT06729983

• National Registry for Artery Embolization to Treat Chronic Pain

  This study is testing if a procedure that blocks blood flow to painful areas can help people with chronic pain from osteoarthritis and other conditions feel better.

  Recruiting at 2 sites Vascular Solutions of North Carolina · Cary, North Carolina and 1 other locations · NCT06477965

• Registry to evaluate outcomes of FX Shoulder replacement devices

  This study is setting up a registry to see how well FX Shoulder replacement devices work for patients after their surgeries over the next few years.

  Recruiting at 4 sites FX Shoulder Solutions · Gilbert, Arizona and 3 other locations · NCT06078865

• Evaluating outcomes of FX Shoulder Solutions implants for shoulder conditions

  This study is testing how well FX Shoulder Solutions implants work for people who have had shoulder replacement surgeries to see if they help patients recover safely and effectively.

  Recruiting FX Shoulder Solutions · Gilbert, Arizona and 1 other locations · NCT06077942

• Comparing two shoulder surgeries for older patients with osteoarthritis

  This study is testing which shoulder surgery works better for older patients with severe arthritis: a total shoulder replacement or a reverse shoulder replacement.

  Recruiting Ottawa Hospital Research Institute · Ottawa, Ontario · NCT05487274

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.