Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT06571227
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2024-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishing the Clinical Significance Values of the Lysholm Knee Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059549', 'term': 'Anterior Cruciate Ligament Reconstruction'}], 'ancestors': [{'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional level', 'timeFrame': 'before the surgery and after 3 months from the surgery', 'description': 'Lysholm Knee Score (total score between 0-100) (higher values indicate higher functional level)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lsholm knee score', 'Anterior cruciate ligament injury', 'Minimal important change', 'Substantial clinical benefit', 'Clinical significance', 'Patient reported outcome'], 'conditions': ['Knee Injuries']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about patients who will undergo anterior cruciate ligament reconstruction. The main questions it aims to answer are:\n\n* What is the minimal clinically important difference value of the Lysholm Knee Score?\n* What is the substantial clinical benefit value of the Lysholm Knee Score?\n* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the minimal clinically important difference value?\n* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the substantial clinical benefit value?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted with people undergoing anterior cruciate ligament reconstruction at Gazi University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to be over 18 years old\n* to undergo surgery for a ruptured anterior cruciate ligament\n\nExclusion Criteria:\n\n* to have metabolic or autoimmune diseases\n* to undergo revision anterior cruciate ligament surgery or anterior cruciate ligament repair\n* to have cognitive issues that will hinder the completion of the study forms\n* to lack sufficient proficiency in Turkish'}, 'identificationModule': {'nctId': 'NCT06571227', 'briefTitle': 'Establishing the Clinical Significance Values of the Lysholm Knee Score', 'organization': {'class': 'OTHER', 'fullName': 'Kırklareli University'}, 'officialTitle': 'Establishing the Clinical Significance Values of the Lysholm Knee Score in Patients Undergoing Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': '2024 - 1202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anterior Cruciate Ligament Reconstruction Patients', 'description': 'Patients who will undergo anterior cruciate ligament reconstruction because of anterior cruciate ligament rupture', 'interventionNames': ['Procedure: Anterior cruciate ligament reconstruction']}], 'interventions': [{'name': 'Anterior cruciate ligament reconstruction', 'type': 'PROCEDURE', 'description': 'Patients with anterior cruciate ligament rupture will undergo anterior cruciate ligament reconstruction surgery.', 'armGroupLabels': ['Anterior Cruciate Ligament Reconstruction Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi Üniversitesi Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ozan Gür, MSc', 'role': 'CONTACT', 'email': 'ozan.gur94@gmail.com', 'phone': '+90 506 338 38 49'}], 'overallOfficials': [{'name': 'Ozan Gür, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kırklareli University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırklareli University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gazi University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Ozan Gür, PT', 'investigatorAffiliation': 'Kırklareli University'}}}}