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

Primary Purpose

Shoulder Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TSA standard
RTSA standard
TSA Blueprint
RTSA Blueprint
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Arthritis focused on measuring Prothesis, Glenoid implantation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital du Sacré-Cœur de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

TSA Standard

RTSA standard

TSA blueprint

RTSA blueprint

Arm Description

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

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

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.

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.

Outcomes

Primary Outcome Measures

Radiological evaluation 1
Comparing the precision of the glenoid implantation during the surgery between both group

Secondary Outcome Measures

Radiological evaluation 2
Comparaison of the glenoid fixation durong the surgery, between both group
Glenoid bone loss
Comparaison of the glenoid bone loss between both group
Surgical time
Comparaison og the surgery time between both group
Blood test
Evaluation of the glenoid quality with nutritional status

Full Information

First Posted
February 6, 2019
Last Updated
June 17, 2022
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT03839758
Brief Title
Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
Acronym
PITSA
Official Title
Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthritis
Keywords
Prothesis, Glenoid implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The evaluator who will perform the follow-up clinical examination will also be blind
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TSA Standard
Arm Type
Active Comparator
Arm Description
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
Arm Title
RTSA standard
Arm Type
Active Comparator
Arm Description
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
Arm Title
TSA blueprint
Arm Type
Experimental
Arm Description
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.
Arm Title
RTSA blueprint
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TSA standard
Intervention Description
Glenoid preparation will be done with 2D CT-Scan
Intervention Type
Procedure
Intervention Name(s)
RTSA standard
Intervention Description
Glenoid preparation will be done with 2D CT-Scan
Intervention Type
Procedure
Intervention Name(s)
TSA Blueprint
Intervention Description
Glenoid preparation will be done with Blueprint software
Intervention Type
Procedure
Intervention Name(s)
RTSA Blueprint
Intervention Description
Glenoid preparation will be done with 2D CT-Scan
Primary Outcome Measure Information:
Title
Radiological evaluation 1
Description
Comparing the precision of the glenoid implantation during the surgery between both group
Time Frame
2 weeks post-op
Secondary Outcome Measure Information:
Title
Radiological evaluation 2
Description
Comparaison of the glenoid fixation durong the surgery, between both group
Time Frame
2 years
Title
Glenoid bone loss
Description
Comparaison of the glenoid bone loss between both group
Time Frame
At surgery
Title
Surgical time
Description
Comparaison og the surgery time between both group
Time Frame
At surgery
Title
Blood test
Description
Evaluation of the glenoid quality with nutritional status
Time Frame
Before surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Rouleau, MD
Phone
514-338-2222
Ext
2050
Email
dominique_rouleau@yahoo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Karine Tardif
Phone
514-338-2222
Ext
3464
Email
karinetardif2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Rouleau, MD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital du Sacré-Cœur de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Rouleau
Phone
514-338-2222
Ext
2050
Email
dominique_rouleau@yahoo.ca
First Name & Middle Initial & Last Name & Degree
Karine Tardif
Phone
514-338-2222
Ext
3465
Email
karinetardif2@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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