Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT02717559
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-14
First Post:
2016-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint space width measured on weight-bearing radiographs', 'timeFrame': '10 years after ACL reconstruction surgery'}, {'measure': 'Pain subscale of the Knee Injury and Osteoarthritis Score (KOOS).', 'timeFrame': '10 years after ACL reconstruction surgery'}], 'secondaryOutcomes': [{'measure': 'Knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS)', 'timeFrame': '10 years after ACL reconstruction surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior cruciate ligament / injuries', 'Anterior cruciate ligament / surgery', 'knee injuries / surgery', 'outcomes research', 'prospective studies', 'osteoarthritis'], 'conditions': ['Osteoarthritis', 'Arthritis', 'Joint Diseases', 'Musculoskeletal Diseases', 'Rheumatic Diseases']}, 'referencesModule': {'references': [{'pmid': '33793363', 'type': 'DERIVED', 'citation': 'MOON Group; Everhart JS, Jones MH, Yalcin S, Reinke EK, Huston LJ, Andrish JT, Cox CL, Flanigan DC, Kaeding CC, Magnussen RA, Obuchowski N, Parker RD, Pedroza AD, Sanders RA, Winalski CS, Spindler KP. The Clinical Radiographic Incidence of Posttraumatic Osteoarthritis 10 Years After Anterior Cruciate Ligament Reconstruction: Data From the MOON Nested Cohort. Am J Sports Med. 2021 Apr;49(5):1251-1261. doi: 10.1177/0363546521995182.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators will examine patients who have undergone unilateral ACL reconstruction surgery to determine which structural and functional characteristics of the knee two and ten years post reconstruction surgery, aspects of the original injury and repair, and patient characteristics are risk factors for osteoarthritis after ACL reconstruction surgery.', 'detailedDescription': 'The purpose of this study is to identify risk factors for signs and symptoms of osteoarthritis two and ten year post ACL reconstruction from information available at the time of surgery. Hypothesis: Smoking status, older age, higher BMI, increased severity of cartilage injuries, increased meniscal resection, revision surgery, and incidence of additional arthroscopic procedures will result in more symptoms and signs of osteoarthritis at 10-year follow-up.\n\nPrimary outcome measures will be the joint space width measured on weight-bearing radiographs, as well as the pain subscale of the Knee Injury and Osteoarthritis Score (KOOS).\n\nSecondary outcome measures will include the knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants enrolled in the Multicenter Orthopaedic Outcomes Network cohort by one of study site surgeons and meeting eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had primary unilateral ACL reconstruction performed by Dr. Kurt Spindler (Vanderbilt University), Dr. Christopher Kaeding (The Ohio State University), Dr. Rick Parker (Cleveland Clinic), Dr. Jack Andrish (Cleveland Clinic), Dr. Rick Wright (Washington University, St. Louis), or Dr. Matthew Matava (Washington University, St. Louis).\n* Participated in the 2 yr onsite visit\n\nExclusion Criteria:\n\n* Unable to be consented\n* Unable to participate for health reasons\n* History of intra-articular knee infection\n* History of total knee arthroplasty on either knee'}, 'identificationModule': {'nctId': 'NCT02717559', 'briefTitle': 'Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up', 'orgStudyIdInfo': {'id': '160049'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kurt P Spindler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University / The Cleveland Clinic Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}, {'name': 'Ohio State University', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjoint Professor', 'investigatorFullName': 'Kurt P. Spindler', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}