Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT06288867
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2024-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D057925', 'term': 'Femoracetabular Impingement'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2024-02-24', 'studyFirstSubmitQcDate': '2024-02-24', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS)', 'timeFrame': 'Baseline, 1 year', 'description': 'The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4). Scores for each subscale range from 0% (least function) to 100% (most function).The highest potential score is 68, a higher score represents a higher level of physical function for both the ADL and sports subscales'}, {'measure': 'Change from baseline in Hip Function, as measured by Harris Hip Score (HHS)', 'timeFrame': 'Baseline, 1 year', 'description': '\\<70 (poor result), 70-79 (fair result), 80-89 (good result) and \\>90 (excellent result)'}, {'measure': 'Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline, 1 year', 'description': 'Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 with 0 indicating no pain, and higher scores indicating greater pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip Arthroscopy', 'Labral Repair', 'Labral Debridement', 'Acetabular Labral Tear'], 'conditions': ['Hip Injuries', 'Acetabular Labral Tear', 'Femoro Acetabular Impingement']}, 'descriptionModule': {'briefSummary': 'This study aims to address hip labral tears and compare between arthroscopic labral repair versus debridement.', 'detailedDescription': "Hip arthroscopy will be performed with the patient under general anesthesia. The patient will be placed in supine position, and traction and joint access will be controlled by fluoroscopy. An anterolateral portal and an inferior mid-anterior portal will be used. Any labral, chondral, and/or bony pathology (cam or pincer) will be treated. Labral tears may be debrided or repaired. Labral repairs will be secured with suture anchors.\n\nPatient's functions will be evaluated preoperatively and postoperatively at 1, 3 and 6 months and 1 year and at the last follow-up using the Harris Hip Score (HHS), visual analog score (VAS), Hip Outcome Score Activities-Daily Living Subscale (HOS-ADL), and Sport-Specific Subscale (HOS-SSS)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: both sexes.\n* Age: 18 years - 60 years.\n* Femoroacetabular impingement (FAI) including all types (cam, pincer, and combined).\n* Traumatic Labral tears\n\nExclusion Criteria:\n\n* Previous hip surgery.\n* Hip joint dysplasia, defined by both center edge (CE) angles \\<25 degrees and Acetabular Index angle \\>10 degrees.\n* Osteoarthritis grade \\>2 according to Tönnis classification.'}, 'identificationModule': {'nctId': 'NCT06288867', 'briefTitle': 'A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Arthroscopic Labral Repair Versus Debridement In Hip Labral Tears: A Prospective Comparative Study', 'orgStudyIdInfo': {'id': 'FMASU MD28/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Labral Repair', 'description': 'Labral tears will be repaired with suture anchors.', 'interventionNames': ['Procedure: Arthroscopic Labral Repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Labral Debridement', 'description': 'Labral Debridement will be done by electrocautery', 'interventionNames': ['Procedure: Arthroscopic Labral Debridement']}], 'interventions': [{'name': 'Arthroscopic Labral Repair', 'type': 'PROCEDURE', 'description': 'Patients with Hip Labral tears will be treated with labral repair', 'armGroupLabels': ['Labral Repair']}, {'name': 'Arthroscopic Labral Debridement', 'type': 'PROCEDURE', 'description': 'Patients with Hip Labral tears will be treated with labral debridement', 'armGroupLabels': ['Labral Debridement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Karim A Salem, MD', 'role': 'CONTACT', 'email': 'karimatefsalem@gmail.com', 'phone': '1000017388', 'phoneExt': '+20'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Karim A Salem, MD', 'role': 'CONTACT', 'email': 'karimatefsalem@gmail.com', 'phone': '1000017388', 'phoneExt': '+20'}], 'overallOfficials': [{'name': 'Karim A Salem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karim Atef Salem', 'investigatorAffiliation': 'Ain Shams University'}}}}