Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT00604734
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2007-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Study On A Total Hip Resurfacing System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2007-12-23', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris Hip Score, Device Revision/Removal, Radiographic Evaluation', 'timeFrame': '2 years postoperative'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Anytime'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Arthritis', 'Avascular Necrosis']}, 'descriptionModule': {'briefSummary': 'This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.', 'detailedDescription': 'The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces.\n\nThe device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.\n\nThe objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.\n\nPerformance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.\n\nPrimary endpoints:\n\n* Total Harris hip score\n* Device revisions or removals\n\nSecondary endpoints:\n\n* Total Harris hip score\n* Radiographic changes as evidenced by:\n\nI. Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a preoperative Total Harris Hip Score of \\< 70\n2. Conservative treatment has proven unsuccessful\n3. Primary hip surgery\n4. Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:\n\n 1. Osteoarthritis\n 2. Avascular necrosis\n 3. Legg Perthes\n 4. Rheumatoid Arthritis\n 5. Juvenile Rheumatoid Arthritis\n 6. Systemic Lupus Erythematosus\n 7. Developmental Dysplasia, which does not prevent stable acetabular reconstruction\n 8. Post traumatic arthritis S. Patients at least 18 years of age\n\n6\\. Patients of all races and gender 7. Patients who are able to follow post-operative care instructions 8. Patients who are willing and able to return for scheduled follow-up evaluations 9. Patient has signed the IRB approved Informed Consent Form\n\nExclusion Criteria:\n\n1. Patients with a preoperative Total Harris Hip Score of \\> 70\n2. Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip\n3. Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures\n4. Developmental dysplasla, which prevents stable acetabular reconstruction\n5. Patients with previous Girdlestone procedures\n6. Patients with above knee amputation of the contralateral and/or ipsilateral leg\n7. Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s)\n8. Active or suspected systemic or localized Infection\n9. Parkinson\'s or Alzheimer\'s Disease\n10. Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis\n11. Patients less than 18 years of age\n12. Patients with condition(s) that may Interfere with the survival of the femoral resurfacing or acetabular replacements or their outcomes,including Paget\'s Disease, Charcot\'s Disease, Sickle Cell Anemia or traits Severe osteoporosis compromising bone stock (I.e.Dorr type C bone Lower extremity muscular atrophy Neuromuscular disease\n13. Patients with a clinical conditions that may limit follow-up,including: immunocompromised conditions, hepatitis, active tuberculosis, neoplastic disease, chronic renal failure, organ transplant recipients, known terminal disease process\n14. Patients with a "fused"hip\n15. Patients with metal allergy or hypersensitivity\n16. Participation in a study of any investigational product (drug or device) within the past 12 months\n17. Prisoners,known drug or alcohol abuser,or mentally incompetent individuals\n18. Systemic steroids within 6 months\n19. Patients with a known malignancy\n20. Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT00604734', 'briefTitle': 'A Prospective Clinical Study On A Total Hip Resurfacing System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective Clinical Study On A Total Hip Resurfacing System', 'orgStudyIdInfo': {'id': 'EU-8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ReCap', 'description': 'ReCap Total Hip Resurfacing System', 'interventionNames': ['Device: ReCap Total Hip Resurfacing System']}], 'interventions': [{'name': 'ReCap Total Hip Resurfacing System', 'type': 'DEVICE', 'otherNames': ['Total hip resurfacing', 'ReCap'], 'description': 'This is a hip resurfacing system.', 'armGroupLabels': ['ReCap']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sint-Niklaas', 'country': 'Belgium', 'facility': 'Az Nikolaas Campus Sint Niklaas', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}], 'overallOfficials': [{'name': 'Jo De Schepper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ Nikolaas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}