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

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ClinicalTrials.gov Identifier: NCT03839758
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Dominique Rouleau, Université de Montréal

Study Description
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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.


Condition or disease Intervention/treatment Phase
Shoulder Arthritis Procedure: TSA standard Procedure: RTSA standard Procedure: TSA Blueprint Procedure: RTSA Blueprint Not Applicable

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:

  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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The evaluator who will perform the follow-up clinical examination will also be blind
Primary Purpose: Treatment
Official Title: Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arms and Interventions
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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
 Procedure: TSA standard
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
 Procedure: RTSA standard
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.
 Procedure: TSA Blueprint
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.
 Procedure: RTSA Blueprint
Glenoid preparation will be done with 2D CT-Scan


Outcome Measures
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Primary Outcome Measures :
  1. Radiological evaluation 1 [ Time Frame: 2 weeks post-op ]
    Comparing the precision of the glenoid implantation during the surgery between both group


Secondary Outcome Measures :
  1. Radiological evaluation 2 [ Time Frame: 2 years ]
    Comparaison of the glenoid fixation durong the surgery, between both group

  2. Glenoid bone loss [ Time Frame: At surgery ]
    Comparaison of the glenoid bone loss between both group

  3. Surgical time [ Time Frame: At surgery ]
    Comparaison og the surgery time between both group

  4. Blood test [ Time Frame: Before surgery ]
    Evaluation of the glenoid quality with nutritional status


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839758


Contacts
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Contact: Dominique Rouleau, MD 514-338-2222 ext 2050 dominique_rouleau@yahoo.ca
Contact: Karine Tardif 514-338-2222 ext 3464 karinetardif2@gmail.com

Locations
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Canada, Quebec
Hôpital du Sacré-Cœur de Montréal Recruiting
Montréal, Quebec, Canada, H4J 1C5
Contact: Dominique Rouleau    514-338-2222 ext 2050    dominique_rouleau@yahoo.ca   
Contact: Karine Tardif    514-338-2222 ext 3465    karinetardif2@gmail.com   
Sponsors and Collaborators
Université de Montréal
Investigators
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Principal Investigator: Dominique Rouleau, MD Université de Montréal
More Information
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Responsible Party: Dominique Rouleau, Orthopaedic surgeon, Université de Montréal
ClinicalTrials.gov Identifier: NCT03839758    
Other Study ID Numbers: PITSA
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dominique Rouleau, Université de Montréal:
Prothesis
Glenoid implantation
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases