Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT03839758
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2019-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The evaluator who will perform the follow-up clinical examination will also be blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological evaluation 1', 'timeFrame': '2 weeks post-op', 'description': 'Comparing the precision of the glenoid implantation during the surgery between both group'}], 'secondaryOutcomes': [{'measure': 'Radiological evaluation 2', 'timeFrame': '2 years', 'description': 'Comparaison of the glenoid fixation durong the surgery, between both group'}, {'measure': 'Glenoid bone loss', 'timeFrame': 'At surgery', 'description': 'Comparaison of the glenoid bone loss between both group'}, {'measure': 'Surgical time', 'timeFrame': 'At surgery', 'description': 'Comparaison og the surgery time between both group'}, {'measure': 'Blood test', 'timeFrame': 'Before surgery', 'description': 'Evaluation of the glenoid quality with nutritional status'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prothesis', 'Glenoid implantation'], 'conditions': ['Shoulder Arthritis']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nIn 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.\n\nThis method may also provide secondary benefits, such as decreasing operating time, lowering short- and long-term complications, and improving efficacy.\n\nThe objective of this study is to evaluate the performance of a patient specific glenoid guide.', 'detailedDescription': '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:\n\n1. 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.\n2. 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with shoulder osteaoarthritis and AVN\n\nExclusion Criteria:\n\n* Patients with previous shoulder arthroplasty\n* Patients with inflammatory arthritis and tumor\n* Patients with previous shoulder surgery with metal implant\n* Patients refusing 2-year follow-up\n* Patients that does not speak English or French\n* Patients with current or previous shoulder infection\n* Patients with graft during surgery'}, 'identificationModule': {'nctId': 'NCT03839758', 'acronym': 'PITSA', 'briefTitle': 'Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': 'Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study', 'orgStudyIdInfo': {'id': 'PITSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TSA Standard', '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', 'interventionNames': ['Procedure: TSA standard']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RTSA standard', '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', 'interventionNames': ['Procedure: RTSA standard']}, {'type': 'EXPERIMENTAL', 'label': 'TSA blueprint', '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.', 'interventionNames': ['Procedure: TSA Blueprint']}, {'type': 'EXPERIMENTAL', 'label': 'RTSA blueprint', '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.', 'interventionNames': ['Procedure: RTSA Blueprint']}], 'interventions': [{'name': 'TSA standard', 'type': 'PROCEDURE', 'description': 'Glenoid preparation will be done with 2D CT-Scan', 'armGroupLabels': ['TSA Standard']}, {'name': 'RTSA standard', 'type': 'PROCEDURE', 'description': 'Glenoid preparation will be done with 2D CT-Scan', 'armGroupLabels': ['RTSA standard']}, {'name': 'TSA Blueprint', 'type': 'PROCEDURE', 'description': 'Glenoid preparation will be done with Blueprint software', 'armGroupLabels': ['TSA blueprint']}, {'name': 'RTSA Blueprint', 'type': 'PROCEDURE', 'description': 'Glenoid preparation will be done with 2D CT-Scan', 'armGroupLabels': ['RTSA blueprint']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dominique Rouleau', 'role': 'CONTACT', 'email': 'dominique_rouleau@yahoo.ca', 'phone': '514-338-2222', 'phoneExt': '2050'}, {'name': 'Karine Tardif', 'role': 'CONTACT', 'email': 'karinetardif2@gmail.com', 'phone': '514-338-2222', 'phoneExt': '3465'}], 'facility': 'Hôpital du Sacré-Cœur de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Dominique Rouleau, MD', 'role': 'CONTACT', 'email': 'dominique_rouleau@yahoo.ca', 'phone': '514-338-2222', 'phoneExt': '2050'}, {'name': 'Karine Tardif', 'role': 'CONTACT', 'email': 'karinetardif2@gmail.com', 'phone': '514-338-2222', 'phoneExt': '3464'}], 'overallOfficials': [{'name': 'Dominique Rouleau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic surgeon', 'investigatorFullName': 'Dominique Rouleau', 'investigatorAffiliation': 'Université de Montréal'}}}}