Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-08 @ 9:48 PM
Study NCT ID:
NCT00533234
Status:
TERMINATED
Last Update Posted:
2017-06-21
First Post:
2007-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ExploR® Modular Radial Head Data Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092482', 'term': 'Elbow Fractures'}, {'id': 'D000092467', 'term': 'Radial Head and Neck Fractures'}], 'ancestors': [{'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D011885', 'term': 'Radius Fractures'}, {'id': 'D005543', 'term': 'Forearm Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'There was a lack of business need to continue this data collection.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2007-09-20', 'studyFirstSubmitQcDate': '2007-09-20', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Revisions, Complications, Adverse Events', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Elbow fracture', 'Elbow dislocation', 'Radial head fracture', 'Radial neck fracture'], 'conditions': ['Degenerative Conditions of the Radial Head/Neck', 'Post-traumatic Conditions of the Radial Head/Neck']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR® Modular Radial Head. This data collection effort will document the clinical outcomes of the radial head.', 'detailedDescription': 'Data collection intervals are:\n\nPre-operative, Operative, 3 Months Post-op, 1 Year Post-op, 3 Years Post-op, and 5 Years Post-op.\n\nData collected includes:\n\nHistorical data, Operative record, Mayo Clinic Performance Index for the Elbow, Quick DASH Outcome Measure, Complications, Lost to Follow-up, Protocol Deviations, and Radiographic evaluation of elbow and wrist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be implanted with the ExploR® Modular Radial Head.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe inclusion criteria will be the same as the indications stated in the FDA cleared (510(k) K040611) and (510(k) K051385) labeling for the device.\n\n1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:\n\n 1. Joint destruction and/or subluxation visible on x-ray\n 2. Resistance to conservative treatment\n2. Primary replacement after fracture of the radial head\n3. Symptomatic sequelae after radial head resection\n4. Revision following failed radial head arthroplasty\n\nThe device is intended for single use with or without bone cement.\n\nModular Radial Head replacement prostheses have received FDA clearance for cemented and non-cemented application.\n\nPatient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity.\n\nExclusion Criteria:\n\nThe exclusion criteria will be the same as the contraindications stated in the FDA cleared labeling (510(k) K040611) and (510(k) K051385) for the device. These contraindications include:\n\nAbsolute contraindications:\n\n1. Infection\n2. Sepsis\n3. Osteomyelitis\n\nRelative contraindications:\n\n1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions\n2. Osteoporosis\n3. Metabolic disorders which may impair bone function\n4. Osteomalacia\n5. Distant foci of infections which may spread to the implant site\n6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.'}, 'identificationModule': {'nctId': 'NCT00533234', 'briefTitle': 'ExploR® Modular Radial Head Data Collection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'ExploR® Modular Radial Head Data Collection', 'orgStudyIdInfo': {'id': '116-U-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ExploR® Modular Radial Head', 'type': 'DEVICE', 'description': 'The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46581', 'city': 'Warsaw', 'state': 'Indiana', 'country': 'United States', 'facility': 'Biomet Orthopedics, LLC', 'geoPoint': {'lat': 41.2381, 'lon': -85.85305}}], 'overallOfficials': [{'name': 'Ken Beres, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biomet Orthopedics, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomet Orthopedics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}