RecruitingNot ApplicableNCT03839758

Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study

Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study


Sponsor

Université de Montréal

Enrollment

112 participants

Start Date

Oct 8, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

The P.I.T.S.A. (Personalized Instrument in Total Shoulder Arthroplasty) Study evaluates whether using 3D-printed, patient-specific surgical guides improves the accuracy and outcomes of total shoulder replacement surgery compared to standard surgical techniques. Shoulder replacement is performed for patients with severe osteoarthritis or avascular necrosis (bone tissue death due to disrupted blood supply). Personalized instruments are custom-made based on each patient's unique anatomy to help surgeons place the implant more precisely. Participants will be followed for two years after surgery to compare results between those who had standard shoulder replacement and those who received the personalized instrument approach. You may be eligible if: - You have been diagnosed with shoulder osteoarthritis or avascular necrosis (AVN) - You are 18 years of age or older - You speak English or French - You are willing to attend 2-year follow-up appointments You may NOT be eligible if: - You have had a previous shoulder replacement on that side - You have inflammatory arthritis or a shoulder tumor - You have previously had shoulder surgery involving metal implants - You have a current or previous shoulder infection - You required a bone graft during the surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURETSA standard

Glenoid preparation will be done with 2D CT-Scan

PROCEDURERTSA standard

Glenoid preparation will be done with 2D CT-Scan

PROCEDURETSA Blueprint

Glenoid preparation will be done with Blueprint software

PROCEDURERTSA Blueprint

Glenoid preparation will be done with 2D CT-Scan


Locations(1)

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03839758


Related Trials