Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-20 @ 8:32 PM
Study NCT ID:
NCT00551668
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2007-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D031222', 'term': 'Patellar Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2000-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-30', 'studyFirstSubmitDate': '2007-10-30', 'studyFirstSubmitQcDate': '2007-10-30', 'lastUpdatePostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of redislocations', 'timeFrame': '7 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patellar Dislocation']}, 'descriptionModule': {'briefSummary': 'The objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation.', 'detailedDescription': 'There is no consensus about management of acute traumatic primary patellar dislocations in young physically active adults. Acute lateral patellar dislocation is a relatively common injury among young adults. Proper treatment for this condition has been researched for decades. However, there is a lack of prospective randomized studies to evaluate the different treatment options for traumatic primary patellar dislocations. Therefore a prospective, randomized study was designed with the aim to compare the outcome of operative versus nonoperative treatment of primary traumatic patellar dislocations in young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An acute primary traumatic patellar dislocation\n\nExclusion Criteria:\n\n* Previous dislocation or subluxation of the patella\n* Pre-existing ipsilateral or contralateral knee pathology\n* Previous knee trauma or patellar fracture.'}, 'identificationModule': {'nctId': 'NCT00551668', 'briefTitle': 'A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Finnish Defense Forces'}, 'officialTitle': 'A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation in Young Adults With a Median 7-Year Follow-Up', 'orgStudyIdInfo': {'id': 'R1199/8.1/D/II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Operative', 'interventionNames': ['Procedure: proximal patellar surgery']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Nonoperative', 'interventionNames': ['Procedure: Nonoperative']}], 'interventions': [{'name': 'proximal patellar surgery', 'type': 'PROCEDURE', 'description': 'Initial proximal patellar surgery', 'armGroupLabels': ['1']}, {'name': 'Nonoperative', 'type': 'PROCEDURE', 'description': 'Nonoperative without surgery', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Harri Pihlajamäki, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre for Military Medicine, Lahti, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Defense Forces', 'class': 'OTHER_GOV'}}}}