Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT03887234
Status:
COMPLETED
Last Update Posted:
2022-12-27
First Post:
2019-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Either the two operation methods is chosen by opening a sealed envelope.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized follow-up study. Two groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-23', 'studyFirstSubmitDate': '2019-01-21', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of wound infections in the clavicular describing the safety of the used implant', 'timeFrame': 'two months', 'description': 'Clinical sign questionnaire, scale 0-1 (no-yes)'}], 'secondaryOutcomes': [{'measure': 'Constant score, scale 0-100, 100 denoting excellent', 'timeFrame': 'Score is taken postoperatively and after two years follow-up', 'description': 'General shoulder test; describes the general state of the shoulder'}, {'measure': 'Simple shoulder test, scale 0-12, 12 denoting excellent', 'timeFrame': 'Score is taken postoperatively and after two years follow-up', 'description': 'General shoulder test; describes the general state of the shoulder'}, {'measure': 'Nottingham clavicle score, scale 20-100, 100 denoting excellent', 'timeFrame': 'Score is taken postoperatively and after two years follow-up', 'description': 'AC joint specific test; describes the state of the AC joint and clavicle'}, {'measure': 'Clavicular tunnel diameter', 'timeFrame': 'The measure is taken postoperatively and after two years follow-up', 'description': 'Describes possible adverse expansion of the tunnel; millimeters'}, {'measure': 'Coracoclavicular distance', 'timeFrame': 'The measure is taken postoperatively and after two years follow-up', 'description': 'Describes possible adverse increase of the coracoclavicular distance; millimeters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AC Joint Dislocation']}, 'descriptionModule': {'briefSummary': 'This study follows early wound healing using knot hiding titanium implants in coracoclavicular ligament reconstruction. A further aim is to compare two techniques where the semitendinosus tendon graft either runs through the coracoid drill hole or goes around the coracoid.', 'detailedDescription': 'A modified arthroscopic technique for coracoclavicular ligament reconstruction was used based on a previous technique where the supportive device and the semi tendon graft share the clavicular and coracoid drill holes. A notable problem with the previous technique was large protruding suture knots on the washer and clavicle, which could predispose to wound infection. In this new modified technique, new implants were introduced. The new implant hides the suture knot and less foreign material is needed.\n\nThe purpose of this study is to follow the patients operated using the new implants with special attention to early clavicular wound healing. A further aim is to compare a technique where the semitendinosus graft runs through clavicular and coracoid drill holes versus a technique where the graft runs under the coracoid process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of chronic acromioclavicular luxation\n\nExclusion Criteria:\n\nSevere new trauma after the treatment'}, 'identificationModule': {'nctId': 'NCT03887234', 'briefTitle': 'Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Arthroscopic Coracoclavicular Ligament Reconstruction Using Knot Hiding Titanium Implants: a Prospective Randomized Two-year Follow up Study Comparing Two Techniques', 'orgStudyIdInfo': {'id': 'R18114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Through the coracoid', 'description': 'The semitendinosus tendon graft goes through the 4.5 mm coracoid drill hole.', 'interventionNames': ['Procedure: Coracoclavicular ligament reconstruction']}, {'type': 'EXPERIMENTAL', 'label': 'Around the coracoid', 'description': 'The semitendinosus tendon graft goes around the coracoid.', 'interventionNames': ['Procedure: Coracoclavicular ligament reconstruction']}], 'interventions': [{'name': 'Coracoclavicular ligament reconstruction', 'type': 'PROCEDURE', 'description': 'Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation', 'armGroupLabels': ['Around the coracoid', 'Through the coracoid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Paavo Nurmi Centre, University of Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Juha O Ranne, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Turku, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dr Juha Ranne', 'investigatorAffiliation': 'University of Turku'}}}}