Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
Study NCT ID:
NCT00663468
Status:
TERMINATED
Last Update Posted:
2020-02-12
First Post:
2008-04-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Sub-capital Fractures of Hip Joint by Using TriboFit™ Acetabular Buffer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Lead surgeon retired.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2009-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2008-04-17', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09-16', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['determine changes in patient pain level', 'determine changes in patient functionality', 'determine changes in patient life quality'], 'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the performance and efficacy during 6 and 12 month post operation.\n\n1. determine changes in patient pain level\n2. determine changes in patient functionality\n3. determine changes in patient life quality'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male that is not younger than 60 years old.\n* Patient suffers from hip fracture that will need hip arthroplasty.\n* Patient that weight less than 150Kg\n* Patient femur head diameter between 40mm - 50mm\n* Mentally normal\n* Patient that could walk before suffering from hip fracture\n* Patient that willing to cooperate with the doctor\n* Patient that signed on the acceptance form\n\nExclusion Criteria:\n\n* Patient that does not willing to cooperate with the doctor\n* Patient that is legally rejected\n* Patient that suffer from cancer\n* Patient that had passed amputation in is limbs\n* Patient that is paralysis\n* Patient that passed CVA or TIA\n* Patient that still recovering from hard wounds or surgery\n* Patient that suffer from infection in the hip joint'}, 'identificationModule': {'nctId': 'NCT00663468', 'briefTitle': 'Treatment of Sub-capital Fractures of Hip Joint by Using TriboFit™ Acetabular Buffer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Active Implants'}, 'orgStudyIdInfo': {'id': 'TLV-0021-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Active Implants', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}