Recruiting

P.I.T.S.A.

Sponsor:

Université de Montréal

Code:

NCT03839758

Conditions

Shoulder Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TSA standard

RTSA standard

TSA Blueprint

RTSA Blueprint

Study Details

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.

Conditions

Shoulder Arthritis

Study ID

NCT03839758

Start date

Oct 8, 2019

Status verified date

Sep, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

TSA standard

Glenoid preparation will be done with 2D CT-Scan

RTSA standard

Glenoid preparation will be done with 2D CT-Scan

TSA Blueprint

Glenoid preparation will be done with Blueprint software

RTSA Blueprint

Glenoid preparation will be done with 2D CT-Scan

Primary outcome measure

  • Radiological evaluation 1 [ Time Frame: 2 weeks post-op ]

Central Contacts and Locations

Central contacts

Locations

Hôpital du Sacré-Cœur de Montréal

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Contacts

More Information

Sponsor

Université de Montréal

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • Prothesis
  • Glenoid implantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2025-09-22.