Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT07068893
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-06', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Functional Assessment', 'timeFrame': 'From enrollment to 2-years postoperative', 'description': 'assessment to measure wrist flexion/extension (degrees), wrist flexion/extension arc (degrees), and composite wrist function'}, {'measure': 'Quick DASH Form', 'timeFrame': 'From enrollment to 2-years postoperative', 'description': 'Assessment of symptoms and ability to perform certain activities.'}], 'secondaryOutcomes': [{'measure': 'Specific types of complications and their incidence rates', 'timeFrame': 'From enrollment to 2-years postoperative', 'description': 'Determine the specific types of complications and their incidence rates with respect to internal brace technique and the gold standard Kirschner wires (K-wire) technique (e.g. range of motion losses, pain, paresthesias, weakness, etc.).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perilunate Dislocation']}, 'descriptionModule': {'briefSummary': 'The purpose of the research study is to determine the overall clinical and radiographic outcome differences between internal brace technique and the gold standard Kirschner wires (K-wire) technique for treatment of perilunate dislocations (e.g. nonunion, reoperation, infection, fixation failure, etc.). A secondary purpose is to determine the specific types of complications and their incidence rates with respect to internal brace technique and the gold standard Kirschner wires (K-wire) technique (e.g. range of motion losses, pain, numbness, weakness, etc).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients, 18 years of age and older, who undergo operative fixation for perilunate dislocations without fracture at the level one trauma center, Orlando Health Orlando Regional Medical Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skeletally mature patients who have undergone surgical fixation of perilunate dislocation\n\nExclusion Criteria:\n\n* Perilunate dislocations with concomitant carpal fracture(s)\n* Pediatric patients (Age \\< 18 years-old)\n* Patients whose age is greater than or equal to 89 years\n* History of previous perilunate dislocation on ipsilateral side'}, 'identificationModule': {'nctId': 'NCT07068893', 'briefTitle': 'A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations', 'organization': {'class': 'OTHER', 'fullName': 'Orlando Health, Inc.'}, 'officialTitle': 'A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations: A Prospective Study', 'orgStudyIdInfo': {'id': '25.007.01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who undergo traditional fixation'}, {'label': 'Patients who undergo fixation using a novel 4-anchor construct with internal bracing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bryan Brown, MD', 'role': 'CONTACT', 'email': 'Bryan.Brown@orlandohealth.com', 'phone': '321-890-7154'}], 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Bryan Brown, MD', 'role': 'CONTACT', 'email': 'Bryan.Brown@orlandohealth.com', 'phone': '321-890-7154'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bryan D Brown,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Hand, Elbow & Shoulder Surgeon', 'investigatorFullName': 'Bryan D Brown,MD', 'investigatorAffiliation': 'Orlando Health, Inc.'}}}}