- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839758
Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study (PITSA)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dominique Rouleau, MD
- Phone Number: 2050 514-338-2222
- Email: dominique_rouleau@yahoo.ca
Study Contact Backup
- Name: Karine Tardif
- Phone Number: 3464 514-338-2222
- Email: karinetardif2@gmail.com
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H4J 1C5
- Recruiting
- Hopital du Sacre-Coeur de Montreal
-
Contact:
- Karine Tardif
- Phone Number: 3465 514-338-2222
- Email: karinetardif2@gmail.com
-
Contact:
- Dominique Rouleau
- Phone Number: 2050 514-338-2222
- Email: dominique_rouleau@yahoo.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with shoulder osteaoarthritis and AVN
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Glenoid preparation will be done with 2D CT-Scan
|
Active Comparator: 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
|
Glenoid preparation will be done with 2D CT-Scan
|
Experimental: 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.
|
Glenoid preparation will be done with Blueprint software
|
Experimental: 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.
|
Glenoid preparation will be done with 2D CT-Scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological evaluation 1
Time Frame: 2 weeks post-op
|
Comparing the precision of the glenoid implantation during the surgery between both group
|
2 weeks post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological evaluation 2
Time Frame: 2 years
|
Comparaison of the glenoid fixation durong the surgery, between both group
|
2 years
|
Glenoid bone loss
Time Frame: At surgery
|
Comparaison of the glenoid bone loss between both group
|
At surgery
|
Surgical time
Time Frame: At surgery
|
Comparaison og the surgery time between both group
|
At surgery
|
Blood test
Time Frame: Before surgery
|
Evaluation of the glenoid quality with nutritional status
|
Before surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dominique Rouleau, MD, Université de Montréal
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PITSA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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