Nctid:
NCT06236204
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000004213", "term"=>"Dissociative Disorders"}], "ancestors"=>[{"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M12307", "name"=>"Neoplasm Metastasis", "relevance"=>"LOW"}, {"id"=>"M7394", "name"=>"Dissociative Disorders", "asFound"=>"Dissociation", "relevance"=>"HIGH"}, {"id"=>"M6515", "name"=>"Conversion Disorder", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"T1568", "name"=>"Conversion Disorder", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"prospective single center - single surgeon"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2023-01-25", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"passive and active range of motion (degrees) operated and contralateral side", "timeFrame"=>"preop", "description"=>"flexion, extension, ulnar and radial deviation"}, {"measure"=>"passive and active range of motion (degrees) operated and contralateral side", "timeFrame"=>"postoperative 3 months", "description"=>"flexion, extension, ulnar and radial deviation"}, {"measure"=>"passive and active range of motion (degrees) operated and contralateral side", "timeFrame"=>"postoperative 6 months", "description"=>"flexion, extension, ulnar and radial deviation"}, {"measure"=>"passive and active range of motion (degrees) operated and contralateral side", "timeFrame"=>"postoperative 12 months", "description"=>"flexion, extension, ulnar and radial deviation"}, {"measure"=>"grip strength (kg) operated and contralateral side", "timeFrame"=>"preop", "description"=>"dynamometer (kg)"}, {"measure"=>"grip strength (kg) operated and contralateral side", "timeFrame"=>"postoperative 3 months", "description"=>"dynamometer (kg)"}, {"measure"=>"grip strength (kg) operated and contralateral side", "timeFrame"=>"postoperative 6 months", "description"=>"dynamometer (kg)"}, {"measure"=>"grip strength (kg) operated and contralateral side", "timeFrame"=>"postoperative 12 months", "description"=>"dynamometer (kg)"}, {"measure"=>"pain (visual analogue scale)", "timeFrame"=>"preop", "description"=>"Visual analogue Scale (0 no pain -10 cm worst pain)"}, {"measure"=>"pain (visual analogue scale)", "timeFrame"=>"postoperative 3 months", "description"=>"Visual analogue Scale Scale (0 no pain -10 cm worst pain)"}, {"measure"=>"pain (visual analogue scale)", "timeFrame"=>"postoperative 6 months", "description"=>"Visual analogue Scale Scale (0 no pain -10 cm worst pain)"}, {"measure"=>"pain (visual analogue scale)", "timeFrame"=>"postoperative 12 months", "description"=>"Visual analogue Scale (0 no pain -10 cm worst pain)"}, {"measure"=>"Disabilities of the Arm, Shoulder and Hand score", "timeFrame"=>"preop", "description"=>"function score (0 is best -100 is worst)"}, {"measure"=>"Disabilities of the Arm, Shoulder and Hand score", "timeFrame"=>"postoperative 3 months", "description"=>"function score (0 is best -100 is worst)"}, {"measure"=>"Disabilities of the Arm, Shoulder and Hand score", "timeFrame"=>"postoperative 6 months", "description"=>"function score (0 is best -100 is worst)"}, {"measure"=>"Disabilities of the Arm, Shoulder and Hand score", "timeFrame"=>"postoperative 12 months", "description"=>"function score (0 is best -100 is worst)"}], "secondaryOutcomes"=>[{"measure"=>"patient satisfaction after treatment", "timeFrame"=>"postoperative 12 months", "description"=>"visual analogue scale (0 is worst -10 cm is best)"}, {"measure"=>"complications", "timeFrame"=>"postoperative 12 months", "description"=>"descriptive"}, {"measure"=>"arthroscopical assessment of the scapholunate stability", "timeFrame"=>"intraoperative", "description"=>"according to European Wrist Arthroscopy Society classification (EWAS1 best -5 worst)"}, {"measure"=>"scapholunate distance, carpal angles", "timeFrame"=>"preop", "description"=>"radiological follow-up (distance in mm or angles in degrees)"}, {"measure"=>"scapholunate distance, carpal angles", "timeFrame"=>"postoperative 12 months", "description"=>"radiological follow-up (distance in mm or angles in degrees)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["scapholunate instability", "reconstruction"], "conditions"=>["Scapholunate Dissociation"]}, "descriptionModule"=>{"briefSummary"=>"Arthroscopical reconstruction of the volar and dorsal part of the scapholunate ligament as treatment for complete scapholunate ligament injury, but reducible carpal malalignment.\n\nThis prospective study aims to evaluate the clinical and functional outcome of this technique on the short and middle term", "detailedDescription"=>"Classical arthroscopic techniques for scapholunate instability consist of debridement, thermal shrinkage, and percutaneous pinning. Good results are obtained in acute lesions or in chronic partial tears, but they are less predictable when the lesion is complete, because of the poor healing capacity of the scapholunate ligament and because it is not possible to perform an anatomic ligamentous reconstruction with these techniques. Open techniques are thus required for reconstruction, but they damage the soft tissues. Corella et al. published a description and cadaver study of an arthroscopic ligamentoplasty, trying to combine the advantages of arthroscopic techniques (minimally invasive surgery) and open techniques (reconstruction of the ligament). With this approach, it is possible to reconstruct the dorsal scapholunate ligament and the secondary stabilizers while causing minimal damage to the soft tissues and avoiding injury to the posterior interosseous nerve and detachment of the dorsal intercarpal ligament. Arthroscopic scapholunate volar and dorsal ligament reconstruction achieves an anatomic reconstruction to provide a strong construct for early mobilization."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Scapholunate dysfunction, complete irrepairable lesion of the SL ligament and the secondary stabilizers (RSC-LRL-SRL) EWAS stage 4-5, no arthritis, with reducible malalignment\n* 18 - 65 years\n\nExclusion Criteria:\n\n* - associated lesions, fractures\n* neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist"}, "identificationModule"=>{"nctId"=>"NCT06236204", "briefTitle"=>"Arthroscopic Scapholunate Ligament Reconstruction", "organization"=>{"class"=>"OTHER", "fullName"=>"Regionaal Ziekenhuis Heilig Hart Tienen"}, "officialTitle"=>"Arthroscopic Scapholunate Ligament Reconstruction, Volar and Dorsal Reconstruction, as Treatment for Dysfunction of the Scapholunate Joint With Insufficiency of the Scapholunate Ligament and Secondary Stabilizers", "orgStudyIdInfo"=>{"id"=>"RZ Tienen EC 109"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Arthroscopic Scapholunate Ligament Reconstruction", "description"=>"Experimental: patients with dynamic scapholunate instability wrist arthroscopy: bone-tendon reconstruction of the volar and dorsal part of the scapholunate complex", "interventionNames"=>["Procedure: Arthroscopic Scapholunate Ligament Reconstruction"]}], "interventions"=>[{"name"=>"Arthroscopic Scapholunate Ligament Reconstruction", "type"=>"PROCEDURE", "description"=>"reconstruction of the SL ligament with palmaris tendon graft tunneled through the scaphoid and lunate as described by Corella et al.", "armGroupLabels"=>["Arthroscopic Scapholunate Ligament Reconstruction"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"3300", "city"=>"Tienen", "country"=>"Belgium", "facility"=>"Department of orthopaedics RZ Tienen", "geoPoint"=>{"lat"=>50.80745, "lon"=>4.9378}}], "centralContacts"=>[{"name"=>"chul ki goorens, MD", "role"=>"CONTACT", "email"=>"cgoorens@msn.com", "phone"=>"0032478907124"}], "overallOfficials"=>[{"name"=>"Kjell Van Royen, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Universitair Ziekenhuis Brussel"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Regionaal Ziekenhuis Heilig Hart Tienen", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"orthopaedic surgeon, principal investigator", "investigatorFullName"=>"Goorens Chul Ki", "investigatorAffiliation"=>"Regionaal Ziekenhuis Heilig Hart Tienen"}}}}
