Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT01740232
Status:
UNKNOWN
Last Update Posted:
2015-01-15
First Post:
2012-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can a Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012421', 'term': 'Rupture'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014207', 'term': 'Trephining'}], 'ancestors': [{'id': 'D003399', 'term': 'Craniotomy'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-14', 'studyFirstSubmitDate': '2012-10-12', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lysholm', 'timeFrame': '4 month', 'description': 'Lysholm questionnaire'}, {'measure': 'rearthroscopy', 'timeFrame': '6 month'}, {'measure': 'KOOS', 'timeFrame': '12 month', 'description': 'Differences between the to arms in the complete KOOS questionnaire.'}, {'measure': 'Lysholm', 'timeFrame': '12 month', 'description': 'Lysholm questionnaire'}, {'measure': 'IKDC', 'timeFrame': '12 month', 'description': 'IKDC questionnaire'}, {'measure': 'IKDC', 'timeFrame': '4 month', 'description': 'IKDC questionnaire'}, {'measure': 'KOOS', 'timeFrame': '4 month', 'description': 'Differences between the to arms in the complete KOOS questionnaire.'}], 'primaryOutcomes': [{'measure': 'KOOS Questionnaire', 'timeFrame': '4 month', 'description': 'Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.'}, {'measure': 'KOOS Questionnaire', 'timeFrame': '12 month', 'description': 'Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Clinical meniscus healing', 'timeFrame': '4 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rupture; Meniscus, Bucket Handle']}, 'descriptionModule': {'briefSummary': 'Meniscus does not always heal when sutured. The investigators will make small holes in the meniscus before repair to promote more bleeding. The investigators expect that will help the meniscus to heal better.', 'detailedDescription': 'RCT study to evaluate the effect on trephination together with meniscal repair on meniscus healing after repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults who have a meniscus repaired.\n\nExclusion Criteria:\n\n* Meniscus not fit for repair.\n* Patients not fit for the repair regime.\n* Arthrosis \\> stadie 2 (ICRS).\n* Prior attempt of repair of the meniscus.'}, 'identificationModule': {'nctId': 'NCT01740232', 'briefTitle': 'Can a Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone?', 'organization': {'class': 'OTHER', 'fullName': 'Amager Hospital'}, 'officialTitle': 'A Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone', 'orgStudyIdInfo': {'id': 'meniskprojekt'}, 'secondaryIdInfos': [{'id': 'H-4-2012-093', 'type': 'OTHER', 'domain': 'Committee on Health Research Ethics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trephination', 'description': 'A 1 x 10 mm pricker are used for the trephination of the meniscus before normal meniscal repair.', 'interventionNames': ['Procedure: trephination']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal meniscal repair', 'description': 'standard operation. Normal meniscalrepair.', 'interventionNames': ['Procedure: Normal meniscal repair']}], 'interventions': [{'name': 'trephination', 'type': 'PROCEDURE', 'description': 'Artroscopic meniskal repair with trephination.', 'armGroupLabels': ['Trephination']}, {'name': 'Normal meniscal repair', 'type': 'PROCEDURE', 'otherNames': ['Normal meniscal suture with FastFix device.'], 'description': 'Artroscopic meniskal repair without trephination.', 'armGroupLabels': ['Normal meniscal repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2300', 'city': 'Copenhagen S', 'state': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mikkel Attrup', 'role': 'CONTACT', 'email': 'mikkel.attrup@regionH.dk', 'phone': '+45 32 34 32 90'}, {'name': 'Mikkel Attrup', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Artroskopisk Center Amager'}, {'zip': '2300', 'city': 'Copenhagen', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mikkel Attrup', 'role': 'CONTACT', 'email': 'mikkel.attrup@regionh.dk', 'phone': '+45 31494239'}, {'name': 'Mikkel Attrup', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Artroskopisk Center Amager', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Mikkel Attrup', 'role': 'CONTACT', 'email': 'mikkel.attrup@regionh.dk', 'phone': '+4531494239'}], 'overallOfficials': [{'name': 'Mikkel Attrup', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Artroscopic Center Amager'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mikkel Lindegaard Attrup', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Staff Specialist 1', 'investigatorFullName': 'Mikkel Lindegaard Attrup', 'investigatorAffiliation': 'Amager Hospital'}}}}