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

NCT03839758 | Recruiting

• 1 other identifier: PITSA
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Keywords

Prothesis; Glenoid implantation

Outcome Measures

Primary Outcomes (1)

• Radiological evaluation 1

  Comparing the precision of the glenoid implantation during the surgery between both group

  2 weeks post-op

Secondary Outcomes (4)

• Radiological evaluation 2

  2 years

• Glenoid bone loss

  At surgery

• Surgical time

  At surgery

• Blood test

  Before surgery

Study Arms (4)

TSA Standard

ACTIVE COMPARATOR

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

Procedure: TSA standard

RTSA standard

ACTIVE COMPARATOR

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

Procedure: RTSA standard

TSA blueprint

EXPERIMENTAL

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.

Procedure: TSA Blueprint

RTSA blueprint

EXPERIMENTAL

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.

Procedure: RTSA Blueprint

Interventions

TSA standard PROCEDURE

Glenoid preparation will be done with 2D CT-Scan

TSA Standard

RTSA standard PROCEDURE

Glenoid preparation will be done with 2D CT-Scan

RTSA standard

TSA Blueprint PROCEDURE

Glenoid preparation will be done with Blueprint software

TSA blueprint

RTSA Blueprint PROCEDURE

Glenoid preparation will be done with 2D CT-Scan

RTSA blueprint

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with shoulder osteaoarthritis and AVN

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

Study Officials

• Dominique Rouleau, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Rouleau, MD

CONTACT

514-338-2222; dominique_rouleau@yahoo.ca

Karine Tardif

CONTACT

514-338-2222; karinetardif2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The evaluator who will perform the follow-up clinical examination will also be blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 15, 2019
• Study Start: October 8, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

CA (1)