Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
NCT ID: NCT03839758
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
112 participants
INTERVENTIONAL
2019-10-08
2028-12-31
Brief Summary
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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.
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Detailed Description
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1. 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.
2. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
TSA standard
Glenoid preparation will be done with 2D CT-Scan
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
RTSA standard
Glenoid preparation will be done with 2D CT-Scan
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.
TSA Blueprint
Glenoid preparation will be done with Blueprint software
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.
RTSA Blueprint
Glenoid preparation will be done with 2D CT-Scan
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Université de Montréal
OTHER
Responsible Party
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Dominique Rouleau
Orthopaedic surgeon
Principal Investigators
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Dominique Rouleau, MD
Role: PRINCIPAL_INVESTIGATOR
Université de Montréal
Locations
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Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PITSA
Identifier Type: -
Identifier Source: org_study_id
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