Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT05476692
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome of Surgical Treatment for Osteochondral Lesions of the Talus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical outcome of the various surgical techniques for treatment of osteochondral lesions of the talus', 'timeFrame': '1 year', 'description': 'clinical outcome of the various surgical techniques for treatment of osteochondral lesions of the talus , Clinical outcome by the AOFAS score ( American Orthopaedic Foot and Ankle Society), the higher score means the better outcome and the lower score means the worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteochondral Lesion of Talus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/28979588/', 'label': 'Management of Osteochondral Lesions of the Talar Dome'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/25606554/', 'label': 'Osteochondritis dissecans of the talus'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/33719632/', 'label': 'Long-term Outcomes of Microfracture for Treatment of Osteochondral Lesions of the Talus'}]}, 'descriptionModule': {'briefSummary': 'Assess clinical and radiological outcome of the various surgical techniques for treatment of osteochondral lesions of the talus', 'detailedDescription': 'Osteochondritis dissecans (OCD) of the talus is a subchondral bone pathology that presents as an osteochondral lesion of the talar dome with consequent articular cartilage abnormalities. Osteochondral lesions of the talus (OLT) are frequent after acute ankle trauma. The natural history of the OLT remains unclear due to paucity of longitudinal follow-up studies. Various treatment strategies have been described for OLT, including conservative treatment and operative treatment However, the current literature does not allow firm evidence-based recommendations concerning the treatment to be established ; Microfracture is the most common reparative surgery for osteochondral lesions of the talus (OLTs). While shown to be effective in short- to midterm outcomes, the fibrocartilage that microfracture produces is both biomechanically and biologically inferior to that of native hyaline cartilage and is susceptible to possible deterioration over time following repair . Arthroscopic debridement (AD) for the osteochondral lesions of the talar dome (OLT) was widely documented in the nineties with satisfactory results. However, in modern treatment algorithms, its role is not described. A frequently used instrument for assessing outcome after ankle and hindfoot injuries is the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the study is a descriptive case series study. The sample will be included from the admitted 40 patients during 12 months from the start of the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 15 to 60 years old.\n* Traumatic and degenerative etiology.\n* without ankle deformity.\n* No inflammatory arthritis.\n* Absent or corrected ligamentous instability\n\nExclusion Criteria:\n\n* Older than 60 years old and younger than 15 years old.\n* Charcot ankle.\n* Vascular injury.'}, 'identificationModule': {'nctId': 'NCT05476692', 'briefTitle': 'Clinical Outcome of Surgical Treatment for Osteochondral Lesions of the Talus', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinical Outcome of Surgical Treatment for Osteochondral Lesions of the Talus', 'orgStudyIdInfo': {'id': 'OCD of the talus'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AOFAS score and VAS', 'type': 'OTHER', 'description': 'Clinical outcome by the Visual analogue scale (VAS) and the American Orthopaedic Foot and Ankle (AOFAS) score.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mena Magdy', 'role': 'CONTACT', 'email': 'menamagdy2353794@gmail.com', 'phone': '01272640608'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mena Magdy Fahmy Dawood', 'investigatorAffiliation': 'Assiut University'}}}}