NCT03839758 Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
| NCT ID | NCT03839758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université de Montréal |
| Condition | Shoulder Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2019-10-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2019-10-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Total shoulder arthroplasty is an effective procedure to improve patients function and to relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this procedure is implanting the glenoid component. Indeed, surgical exposure is difficult and proper visualization of the glenoid is demanding. The current free-hand method is not precise and especially unreliable in glenoids with severe deformity. Inappropriate reaming and glenoid positioning can cause more bone loss during surgery. In anatomic prostheses, glenoid component fixation is demanding and is the first component to present loosening at long term follow-up. When it comes to reverse arthroplasty, the glenoid component, once again, requires the most attention. Malpositioning of the glenosphere can cause notching, loosening, and instability. In order to prevent these complications, precision in glenoid implantation is key. To this end, intraoperative computer navigation would be a helpful tool, but the increased expenses in computer equipment represent massive costs and possibly increases in surgical time. A more affordable option is a personalized guide, for which the only extra expense is the customized guide. These guides are based on precise 3D CT scan templates. Previous studies have evaluated the precision of the guide in vivo and in vitro, but none have measured it in a randomized study. As it represents additional costs, its efficacy needs to be proven before widespread use. This method may also provide secondary benefits, such as decreasing operating time, lowering short- and long-term complications, and improving efficacy. The objective of this study is to evaluate the performance of a patient specific glenoid guide.
Eligibility 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
Contact & Investigator
Dominique Rouleau, MD
PRINCIPAL INVESTIGATOR
Université de Montréal
Frequently Asked Questions
Who can join the NCT03839758 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Shoulder Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03839758 currently recruiting?
Yes, NCT03839758 is actively recruiting participants. Contact the research team at dominique_rouleau@yahoo.ca for enrollment information.
Where is the NCT03839758 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT03839758 clinical trial?
NCT03839758 is sponsored by Université de Montréal. The principal investigator is Dominique Rouleau, MD at Université de Montréal. The trial plans to enroll 112 participants.