Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-06 @ 7:34 PM
Study NCT ID:
NCT06024850
Status:
RECRUITING
Last Update Posted:
2024-09-20
First Post:
2023-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D031221', 'term': 'Knee Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional score : International Knee Documentation Committee (IKDC)', 'timeFrame': 'Months : 0, 6 and 12', 'description': 'The International Knee Documentation Committee (IKDC) is a questionnaire that assigns patients an overall functional score. Three categories are examined by the questionnaire: symptoms, sports activity and knee function, on a scale of 0 to 100.'}], 'secondaryOutcomes': [{'measure': 'Functional score : Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Months : 0, 6 and 12', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is used to assess immediate and long-term patient outcomes after knee injury. Five outcomes are assessed by the self-administered KOOS: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life, on a scale of 0 to 100.'}, {'measure': 'Visual Analogue Scale (VAS) scale', 'timeFrame': 'Months: 0, 6 and 12', 'description': 'Analysis of the Visual Analogue Scale (VAS) scale (from 0 to 10, 10 = pain ++)'}, {'measure': 'Laxity', 'timeFrame': 'Month : 12', 'description': 'Laxity assessed by Magnetic Resonance Imaging (MRI)'}, {'measure': 'Joint amplitudes', 'timeFrame': 'Months: 0, 6 and 12', 'description': 'Joint amplitudes assessed by the iso-cinetic test'}, {'measure': 'Clinical data', 'timeFrame': 'Month : 0', 'description': 'Data collected at inclusion'}, {'measure': 'Recovery of muscle function', 'timeFrame': 'Month : 12', 'description': 'Recovery of muscle function measured by iso kinetic muscle assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiligamentar', 'injury', 'knee', 'magnetic resonance imaging (MRI)', 'knee reconstruction', 'knee dislocation'], 'conditions': ['Knee Ligament Injury']}, 'descriptionModule': {'briefSummary': 'Multiligamentar knee injury has consequences on knee function (instability, arthritis, life disagreement). Surgical reconstructions have known recent evolutions. The goal of this study is to evaluate functional and clinical results at one year of those new surgical technics. A clinical and functional follow up will be performed before the surgery, then at 6 months and one year.', 'detailedDescription': 'Patients will also benefit of a Magnetic Resonance Imaging (MRI) and isokinetic evaluations at one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne\n\nExclusion Criteria:\n\n* Refusal'}, 'identificationModule': {'nctId': 'NCT06024850', 'briefTitle': 'Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)', 'orgStudyIdInfo': {'id': 'IRBN342022/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'multiligamentar knee reconstruction', 'description': 'Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included.\n\nDatas collected by medical record.', 'interventionNames': ['Other: Datas collected']}], 'interventions': [{'name': 'Datas collected', 'type': 'OTHER', 'description': 'Datas collected by medical record: medical data (weight, height, smoking status, history) and socio-demographic data (age, occupation, type of injury) information, assessment of knee function before surgery, at 6 months and 1 year after surgery, magnetic resonance imaging (MRI) and radiological imaging at 1 year after surgery, results of the Iso-kinetic Muscle Assessment Test at 1 year after surgery to objectively determine the recovery of muscle function\n\nThe data collected will be used to perform a statistical analysis to evaluate the factors predicting a good long-term post-surgical evolution', 'armGroupLabels': ['multiligamentar knee reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas NERI, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pierre-Henri VERMOREL, resident', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Thomas NERI, MD PhD', 'role': 'CONTACT', 'email': 'Thomas.Neri@chu-st-etienne.fr', 'phone': '(0)477127549', 'phoneExt': '+33'}, {'name': 'Pierre-Henri VERMOREL, resident', 'role': 'CONTACT', 'email': 'vermoph@hotmail.fr', 'phone': '(0)477127549', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Thomas NERI, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}