Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-31 @ 7:57 PM
Study NCT ID:
NCT01288066
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2011-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062785', 'term': 'Hemiarthroplasty'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2011-01-31', 'studyFirstSubmitQcDate': '2011-02-01', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Constant score assessment of shoulder function and pain', 'timeFrame': 'Baseline to 5 years postsurgery', 'description': 'The primary outcome measure is the difference between the Constant score assessment of shoulder function and pain at baseline and 5 years after surgery. This difference is assessed for each individual patient.'}], 'secondaryOutcomes': [{'measure': 'Constant score', 'timeFrame': '6 months, 1 year, 3 years'}, {'measure': 'Shoulder Pain and Disability Index (SPADI)', 'timeFrame': '6 months, 1 year, 3 years, 5 years'}, {'measure': 'Duration of surgery', 'timeFrame': '1-2 days'}, {'measure': 'Numbers of adverse events', 'timeFrame': 'Baseline to 5 years follow-up'}, {'measure': 'Survivorship of implants', 'timeFrame': 'Baseline to 5 years follow-up'}, {'measure': 'Quality of life related to health', 'timeFrame': 'Baseline, 6 months, 1 year, 3 years, 5 years', 'description': 'Quality of life is assessed using the Euroqol - 5 Dimensions (EQ-5D) questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Shoulder', 'Total arthroplasty', 'Hemiarthroplasty', 'Resurfacing', 'Glenoid', 'Constant score'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power. In this study, patients are randomly allocated to a treatment with a hemi- or total shoulder arthroplasty using implants of the Epoca system. The primary objective is the comparison of pain and function between the treatment groups after 5 years using the Constant score.', 'detailedDescription': 'Shoulder arthroplasty is accepted as the treatment of choice for improved function with minimum pain in well-selected patients. A persistent discussion remains as to whether replacement of the glenoid (ie, total arthroplasty) should be performed. Possible advantages of glenoid replacement include decreased pain compared to hemiarthroplasty with a metal-on-bone articulation, increased stability due to the conforming glenoid component, and lateralization of the joint center providing improved range of motion and abduction strength. Potential complications of glenoid replacement are implant loosening and loss of glenoid bone stock.\n\nIf a hemiarthroplasty is performed, glenoid replacement and related complications are avoided. In addition, hemiarthroplasty requires less surgical time and is less expensive than total shoulder arthroplasty.\n\nTo date, there is no evidence to answer the clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease. In this study, both the stemmed Epoca humeral component (Epoca Stem) and the Epoca Resurfacing Head (Epoca RH) are included. While the stemmed prosthesis was developed both for nonreconstructable fractures and omarthroses, the humeral resurfacing head implant was designed specifically for use in degenerative diseases of the shoulder joint.\n\nThis randomized multicenter study aims to compare the efficacy of hemi versus total shoulder arthroplasty using Epoca RH or Epoca Stem in patients with degenerative joint diseases. The primary aim of the present study is to demonstrate that the Constant score assessing shoulder function and pain is higher in the patient group treated with total arthroplasty compared to the hemiarthroplasty group after 5 years. The secondary aims of the study are to assess differences in the Shoulder Pain and Disability Index (SPADI), duration of surgery, rates of local and general adverse events and relationship to the device or treatment under investigation, survivorship of the implants, and quality of life after 6 months, 1, 3 and 5 years between the treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Primary or secondary omarthrosis (eg, rheumatoid arthritis, avascular head necrosis)\n* Glenoid morphologic type A1, A2 or B1 according to Walch\n* Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation\n* Written informed consent\n\nExclusion Criteria:\n\nPreoperative:\n\n* Posttraumatic omarthrosis\n* Biconcave aspect of glenoid (Walch type B2)\n* Retroversion of glenoid more than 25° (Walch type C)\n* "Epoca Reko" prosthesis\n* Humerus fractures\n* Patients with a severe systemic disease: class III-IV according to the American Society of Anaesthesiologists physical status classification (ASA)\n* Substance abuse that would preclude reliable assessment\n* Pregnancy\n* Prisoners\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study\n\nIntraoperative:\n\n* Full thickness tear of rotator cuff\n* Indication for hemiarthroplasty only\n* Indication for total arthroplasty only\n* Intraoperative decision to use implants other than Epoca'}, 'identificationModule': {'nctId': 'NCT01288066', 'acronym': 'Epoca H vs T', 'briefTitle': 'Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'A Randomized Multicenter Study Comparing the Effectiveness of Hemi Versus Total Shoulder Arthroplasty in Patients With a Degenerative Joint Disease', 'orgStudyIdInfo': {'id': 'Epoca Hemi vs. Total 2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hemiarthroplasty', 'description': 'Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system.', 'interventionNames': ['Procedure: Hemiarthroplasty']}, {'type': 'OTHER', 'label': 'Total arthroplasty', 'description': 'Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system.', 'interventionNames': ['Procedure: Total arthroplasty']}], 'interventions': [{'name': 'Hemiarthroplasty', 'type': 'PROCEDURE', 'description': 'Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.', 'armGroupLabels': ['Hemiarthroplasty']}, {'name': 'Total arthroplasty', 'type': 'PROCEDURE', 'description': 'Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.', 'armGroupLabels': ['Total arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medizinische Universität', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '30880', 'city': 'Laatzen', 'country': 'Germany', 'facility': 'Klinikum Region Hannover GmbH, Klinikum Agnes-Karll Laatzen', 'geoPoint': {'lat': 52.31506, 'lon': 9.79739}}, {'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Universitetssjukhuset Ortopedicentrum i Östergötland', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Norbert Suedkamp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Freiburg, Deutschland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Innovation Translation Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Synthes GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}