Personalized approach to shoulder joint replacement
Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
NA · Université de Montréal · NCT03839758
This study is testing if using a personalized guide based on CT scans during shoulder replacement surgery can help people with shoulder arthritis recover better than using standard guides.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Université de Montréal (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT03839758 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a personalized glenoid guide in total shoulder arthroplasty for patients with shoulder arthritis. Participants will be randomized into two groups: one using a patient-specific guide based on preoperative CT scans and the other using a standard method with generic guides. The study aims to improve the precision of glenoid component implantation, which is crucial for reducing complications such as loosening and instability. Preoperative assessments will include demographic data, range of motion, quality of life, and functional status.
Who should consider this trial
Good fit: Ideal candidates are patients with shoulder osteoarthritis or avascular necrosis scheduled for elective primary total shoulder arthroplasty.
Not a fit: Patients with previous shoulder arthroplasty, inflammatory arthritis, or those who cannot commit to a two-year follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for patients undergoing shoulder replacement surgery.
How similar studies have performed: While the use of personalized guides in orthopedic surgery is gaining traction, this specific approach in total shoulder arthroplasty is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with shoulder osteaoarthritis and AVN Exclusion Criteria: * Patients with previous shoulder arthroplasty * Patients with inflammatory arthritis and tumor * Patients with previous shoulder surgery with metal implant * Patients refusing 2-year follow-up * Patients that does not speak English or French * Patients with current or previous shoulder infection * Patients with graft during surgery
Where this trial is running
Montreal, Quebec
- Hôpital du Sacré-Cœur de Montréal — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Dominique Rouleau, MD — Université de Montréal
- Study coordinator: Dominique Rouleau, MD
- Email: dominique_rouleau@yahoo.ca
- Phone: 514-338-2222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Shoulder Arthritis, Prothesis, Glenoid implantation