Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04313556
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lysholm Knee Score', 'timeFrame': '12 months', 'description': 'Eight sections are assessed to produce an overall score on a scale of 0 to 100. Then an assignment is given as "excellent" for 95 to 100 points; "good" for 85 to 94 points, "fair" for 65 to 84 points, or "poor" for less than 65 points'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lateral patellar compression syndrome', 'Arthroscopic lateral release', 'Lysholm score'], 'conditions': ['Knee Pain Chronic']}, 'descriptionModule': {'briefSummary': 'We performed a prospective case series study of 48 patients who suffered Lateral patellar compression syndrome who were diagnosed by clinical examination and confirmed by M.R.I. and failed conservative management and underwent isolated arthroscopic lateral patellar retinaculum release in Erbil Teaching Hospital, PAR Private Hospital and Hawler Private Hospital between December 2016 and August 2019.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lateral patellar compression syndrome proved by clinical,MRI and Arthroscopic examination\n\nExclusion Criteria:\n\n1. Dislocated or history of dislocation.\n2. Patellar instability.\n3. Bony abnormality (trochlear groove hypoplasia or flat).\n4. Osteoarthritis of the knee 3rd and 4th grades.\n5. Infected knee.\n6. Varus and valgus knee.\n7. Rotational deformity of the lower extremity.\n8. Miserable malalignment triad.\n9. Anterior cruciate ligament, posterior cruciate ligament and medial collateral ligament rupture.\n10. History of fracture around knee.\n11. Focal Osteoarthritis of the lateral facet joint.\n12. Chondral lesion (Outerbridge 3 and 4).'}, 'identificationModule': {'nctId': 'NCT04313556', 'briefTitle': 'Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hawler Medical University'}, 'officialTitle': 'Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome', 'orgStudyIdInfo': {'id': 'HMU/Sherwan8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lateral patellar release', 'description': 'Arthroscopic lateral patellar retinacular release', 'interventionNames': ['Procedure: Lateral patellar release']}], 'interventions': [{'name': 'Lateral patellar release', 'type': 'PROCEDURE', 'description': 'Arthroscopic lateral patellar reticular release', 'armGroupLabels': ['Lateral patellar release']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hawler Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of orthopedic surgery', 'investigatorFullName': 'Sherwan Ahmed Ali Hamawandi', 'investigatorAffiliation': 'Hawler Medical University'}}}}