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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

PITSA Trial 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.Check my eligibility

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.See study design

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.

PITSA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have shoulder arthritis and bone death.

PITSA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

PITSA 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Université de MontréalLead Sponsor

214 Previous Clinical Trials

102,659 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals being enrolled in this experiment at present?

"Affirmative. According to clinicaltrials.gov, this trial is still seeking participants and was originally listed on October 8th 2019; the page has been recently updated June 17 2022. 112 candidates are needed at one center for participation in the study."

Answered by AI

Is the eligibility for this research limited to subjects aged 18 or older?

"According to the eligibility criteria, individuals aged 18-99 are welcome to take part. Additionally, there exist specific trials for minors and seniors; respectively comprising 52 and 323 participants."

Answered by AI

What kind of individuals has been identified as ideal for this trial?

"Applicants to this medical trial must have a diagnosis of arthritis and fall between 18-99 years old. 112 volunteers are sought out in total."

Answered by AI

What is the estimated participant count for this research project?

"Affirmative, the information on clinicaltrials.gov is indicative of this trial's active recruitment status. As per the data hosted online, it was first posted on October 8th 2019 and has since been updated most recently on June 17th 2022. 112 people are sought to participate in 1 medical centre for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Dominique Rouleau 2019. "Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03839758.