Shoulder ArthritisPITSANCT03839758
Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
A study testing TSA standard, RTSA standard and TSA Blueprint in people with Shoulder Arthritis, run by Université de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Shoulder Arthritis
- What is being tested?
- TSA standard, RTSA standard and TSA Blueprint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 8 Oct 2019to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with shoulder osteaoarthritis and AVN
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
Dominique Rouleau, 514-338-2222 ext. 2050, dominique_rouleau@yahoo.ca
Karine Tardif, 514-338-2222 ext. 3465, karinetardif2@gmail.com
About this study
Official title: Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
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.
Read more
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.
Read the detailed description
All participants scheduled for elective primary total shoulder arthroplasty will be contacted by a research assistant. Preoperative status will be characterized by demographic data, range of motion, quality of life, and functional status. A CT Scan and x-rays are part of standard preoperative care and always done prior to total shoulder replacement in our institution; these images will be collected for the study. Patients will be randomized to one of the two groups:
- Patient-specific glenoid guide group: 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.
- Classic method group: 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.
The investigators will use the classification proposed by Iannotti et al. to characterize glenoid bone loss prior to surgery. Glenoid bone density will be measured using radiology software (Hounsfield units). Blueprint software will be used to measure the preoperative anatomical characteristics of the glenoid: surface area, version, inclination and subluxation. This will be done prior to surgery in the patient specific group and after surgery in the classic group.
- Conditions
- Shoulder Arthritis
- Being tested
- TSA standard, RTSA standard, TSA Blueprint, RTSA Blueprint
- Keywords
- Prothesis, Glenoid implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSA standardProcedure or surgery
Glenoid preparation will be done with 2D CT-Scan
RTSA standardProcedure or surgery
Glenoid preparation will be done with 2D CT-Scan
TSA BlueprintProcedure or surgery
Glenoid preparation will be done with Blueprint software
RTSA BlueprintProcedure or surgery
Glenoid preparation will be done with 2D CT-Scan
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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. Receives: Procedure: RTSA Blueprint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological evaluation 1
Comparing the precision of the glenoid implantation during the surgery between both group
Measured: 2 weeks post-op
Secondary outcomes (4)
Radiological evaluation 2
Comparaison of the glenoid fixation durong the surgery, between both group
Measured: 2 years
Glenoid bone loss
Comparaison of the glenoid bone loss between both group
Measured: At surgery
Surgical time
Comparaison og the surgery time between both group
Measured: At surgery
Blood test
Evaluation of the glenoid quality with nutritional status
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start8 Oct 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Rouleau, Université de Montréal
- Investigators
- Dominique Rouleau, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839758
- Sponsor's protocol ID
- PITSA
- Acronym
- PITSA
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2019
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
- ClinicalTrials.gov ID
- NCT03839758
- Acronym / sponsor ID
- PITSA / PITSA
- Conditions
- Shoulder Arthritis
- Keywords
- Prothesis, Glenoid implantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All participants scheduled for elective primary total shoulder arthroplasty will be contacted by a research assistant. Preoperative status will be characterized by demographic data, range of motion, quality of life, and functional status. A CT Scan and x-rays are part of standard preoperative care and always done prior to total shoulder replacement in our institution; these images will be collected for the study. Patients will be randomized to one of the two groups:
- Patient-specific glenoid guide group: 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.
- Classic method group: 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.
The investigators will use the classification proposed by Iannotti et al. to characterize glenoid bone loss prior to surgery. Glenoid bone density will be measured using radiology software (Hounsfield units). Blueprint software will be used to measure the preoperative anatomical characteristics of the glenoid: surface area, version, inclination and subluxation. This will be done prior to surgery in the patient specific group and after surgery in the classic group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TSA Standard | Active comparator | Procedure: TSA standardThis 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 |
| RTSA standard | Active comparator | Procedure: RTSA standardThis 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 |
| TSA blueprint | Experimental | Procedure: TSA BlueprintThis 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. |
| RTSA blueprint | Experimental | Procedure: RTSA BlueprintThis 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with shoulder osteaoarthritis and AVN
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSA standardGlenoid preparation will be done with 2D CT-Scan | Procedure or surgery | TSA Standard |
| RTSA standardGlenoid preparation will be done with 2D CT-Scan | Procedure or surgery | RTSA standard |
| TSA BlueprintGlenoid preparation will be done with Blueprint software | Procedure or surgery | TSA blueprint |
| RTSA BlueprintGlenoid preparation will be done with 2D CT-Scan | Procedure or surgery | RTSA blueprint |
Primary outcome
Radiological evaluation 1
Time frame: 2 weeks post-op
Comparing the precision of the glenoid implantation during the surgery between both group
4 secondary outcomes
Radiological evaluation 2
Time frame: 2 years
Glenoid bone loss
Time frame: At surgery
Surgical time
Time frame: At surgery
Blood test
Time frame: Before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominique Rouleau, MD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSA standard, RTSA standard and TSA Blueprint in people with Shoulder Arthritis, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique Rouleau, MD (514-338-2222 ext. 2050, dominique_rouleau@yahoo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological evaluation 1 (time frame: 2 weeks post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.