Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05002335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2021-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D002805', 'term': 'Chondrocalcinosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '5 years', 'description': 'Kaplan Meier method'}], 'secondaryOutcomes': [{'measure': 'Clinical outcome; Constant and Murley score', 'timeFrame': '1, 2, and 5 years', 'description': 'Constant \\& Murley Score: Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. The pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points.'}, {'measure': 'Functional outcome: Oxford Shoulder Score', 'timeFrame': '1, 2, and 5 years', 'description': "Oxford Shoulder Score: It contains 12 items, each with 5 potential answers. A mark between 1 (best/fewest symptoms) and 5 (worst/most severe) is awarded to correspond to the patient's symptoms. The combined total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability"}, {'measure': 'Radiographic performance of the implants: Presence of radiolucencies', 'timeFrame': '3 months, 1, 2, and 5 years', 'description': 'Presence of radiolucencies'}, {'measure': 'Quality of life assesed by EQ-5D-5L score', 'timeFrame': '1, 2, and 5 years', 'description': "EQ-5D-5L score: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.\n\nThe EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement."}, {'measure': 'Number of Intraoperative and postoperative Adverse events', 'timeFrame': 'intraop, 3 months, 1, 2, and 5 years', 'description': 'Intraoperative and postoperative adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Osteoarthritis', 'Secondary Osteoarthritis', 'Rotator Cuff Tear Arthropathy', 'Rheumatoid Arthritis Shoulder', 'Avascular Necrosis', 'Fracture', 'Revision of Shoulder Arthroplasty']}, 'descriptionModule': {'briefSummary': 'This is a post-market surveillance study on Medacta Shoulder System'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring Total Shoulder Arthroplasty (anatomic/reverse) and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-market surveillance study during their pre-operative visit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n* Patient with one of the following diagnosis:\n\n 1. Primary osteoarthritis\n 2. Secondary osteoarthritis\n 3. Cuff tear arthropathy; insufficient rotator cuff\n 4. Acute fracture (\\<21d)\n 5. Rheumatoid or inflammatory arthritis\n 6. Avascular necrosis\n 7. Other posttraumatic condition\n 8. Revision of shoulder arthroplasty\n\nExclusion Criteria:\n\n* Patients with malignant diseases (at the time of surgery)\n* Patients with proven or suspect infections (at the time of surgery)\n* Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)\n* Patients with known incompatibility or allergy to products materials (at the time of surgery)'}, 'identificationModule': {'nctId': 'NCT05002335', 'briefTitle': 'Clinical and Radiological Outcomes of Medacta Shoulder System (BE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'Clinical and Radiological Outcomes of Medacta Shoulder System (BE)', 'orgStudyIdInfo': {'id': 'P06.001.05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medacta Shoulder System', 'type': 'DEVICE', 'description': 'Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '8310', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Lucas', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '5004', 'city': 'Namur', 'country': 'Belgium', 'facility': 'Clinique St-Luc Bouge', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}], 'overallOfficials': [{'name': 'Bart Berghs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ Sint-Jan (Brugge, Belgium)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}