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Procedure

Personalized Instrument for Total Shoulder Arthroplasty (PITSA Trial)

N/A
Recruiting
Led By Dominique Rouleau, MD
Research Sponsored by Université de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with shoulder osteaoarthritis and AVN
Be older than 18 years old
Must not have
Patients with inflammatory arthritis and tumor
Patients with current or previous shoulder infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial will compare the accuracy of a patient specific guide (PSG) with a free-hand technique in total shoulder arthroplasty (TSA).

Who is the study for?
This trial is for patients with shoulder osteoarthritis and AVN who haven't had previous shoulder replacements or surgeries involving metal implants. Participants must speak English or French, agree to a 2-year follow-up, and have no history of shoulder infections, inflammatory arthritis, or tumors.
What is being tested?
The study is testing personalized guides against standard methods in total shoulder arthroplasty (shoulder replacement surgery) to see if they improve the precision of implanting the glenoid component, potentially reducing surgery time and complications.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects from similar surgical procedures may include pain at the site of surgery, swelling, infection risk post-operation, stiffness or difficulty moving the joint initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have shoulder arthritis and bone death.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have both inflammatory arthritis and a tumor.
Select...
I have had a shoulder infection in the past or have one currently.
Select...
I received a graft during surgery.
Select...
I have had a shoulder replacement surgery.
Select...
I am not willing to commit to a 2-year follow-up.
Select...
I have had shoulder surgery with a metal implant.
Select...
I do not speak English or French.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiological evaluation 1
Secondary outcome measures
Blood test
Glenoid bone loss
Radiological evaluation 2
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: TSA blueprintExperimental Treatment1 Intervention
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.
Group II: RTSA blueprintExperimental Treatment1 Intervention
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.
Group III: TSA StandardActive Control1 Intervention
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
Group IV: RTSA standardActive Control1 Intervention
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

Find a Location

Who is running the clinical trial?

Université de MontréalLead Sponsor
218 Previous Clinical Trials
102,986 Total Patients Enrolled
Dominique Rouleau, MDPrincipal InvestigatorUniversité de Montréal
2 Previous Clinical Trials
88 Total Patients Enrolled

Media Library

RTSA Blueprint (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03839758 — N/A
Shoulder Arthritis Research Study Groups: TSA Standard, TSA blueprint, RTSA blueprint, RTSA standard
Shoulder Arthritis Clinical Trial 2023: RTSA Blueprint Highlights & Side Effects. Trial Name: NCT03839758 — N/A
RTSA Blueprint (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03839758 — N/A
~16 spots leftby Jul 2025
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