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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Patients with shoulder osteaoarthritis and AVN

Locations
Other Locations
Canada
Hôpital du Sacré-Cœur de Montréal
RECRUITING
Montreal
Contact Information
Primary
Dominique Rouleau, MD
dominique_rouleau@yahoo.ca
514-338-2222
Backup
Karine Tardif
karinetardif2@gmail.com
514-338-2222
Time Frame
Start Date: 2019-10-08
Estimated Completion Date: 2028-12
Participants
Target number of participants: 112
Treatments
Active_comparator: TSA Standard
This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used
Active_comparator: RTSA standard
This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used
Experimental: TSA blueprint
This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.
Experimental: RTSA blueprint
This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.
Related Therapeutic Areas
Sponsors
Leads: Université de Montréal

This content was sourced from clinicaltrials.gov