Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-05 @ 2:31 PM
Study NCT ID:
NCT00478894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): Onsite Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 432}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2007-05-24', 'studyFirstSubmitQcDate': '2007-05-24', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Side to side knee joint space difference as seen on x-ray', 'timeFrame': '2-20 years post surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anterior cruciate ligament / injuries', 'Anterior cruciate ligament / surgery', 'knee injuries / surgery', 'outcomes research', 'prospective studies', 'osteoarthritis'], 'conditions': ['Rupture of Anterior Cruciate Ligament', 'Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '21445595', 'type': 'RESULT', 'citation': 'Reinke EK, Spindler KP, Lorring D, Jones MH, Schmitz L, Flanigan DC, An AQ, Quiram AR, Preston E, Martin M, Schroeder B, Parker RD, Kaeding CC, Borzi L, Pedroza A, Huston LJ, Harrell FE Jr, Dunn WR. Hop tests correlate with IKDC and KOOS at minimum of 2 years after primary ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1806-16. doi: 10.1007/s00167-011-1473-5. Epub 2011 Mar 29.'}, {'pmid': '31589465', 'type': 'DERIVED', 'citation': 'Ramkumar PN, Tariq MB; MOON Knee Group; Amendola A, Andrish JT, Brophy RH, Dunn WR, Flanigan DC, Huston LJ, Jones MH, Kaeding CC, Kattan MW, Marx RG, Matava MJ, McCarty EC, Parker RD, Vidal AF, Wolcott ML, Wolf BR, Wright RW, Spindler KP. Risk Factors for Loss to Follow-up in 3202 Patients at 2 Years After Anterior Cruciate Ligament Reconstruction: Implications for Identifying Health Disparities in the MOON Prospective Cohort Study. Am J Sports Med. 2019 Nov;47(13):3173-3180. doi: 10.1177/0363546519876925. Epub 2019 Oct 7.'}, {'pmid': '30074823', 'type': 'DERIVED', 'citation': 'Jacobs CA, Peabody MR, Lattermann C, Vega JF, Huston LJ, Spindler KP; MOON Knee Group; Amendola A, Andrish JT, Brophy RH, Dunn WR, Flanigan DC, Jones MH, Kaeding CC, Marx RG, Matava MJ, McCarty EC, Parker RD, Reinke EK, Wolcott ML, Wolf BR, Wright RW, Vidal AF. Development of the KOOSglobal Platform to Measure Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2018 Oct;46(12):2915-2921. doi: 10.1177/0363546518789619. Epub 2018 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'In this study we 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 identify risk factors for signs and symptoms of osteoarthritis two and ten year post ACL reconstruction from information available at the time of surgery; including patient characteristics (age, gender, body mass index (BMI), activity level, clinical knee alignment), their injuries ("pop" heard at the time of injury, concurrent meniscus, articular cartilage, and collateral ligament injuries), and treatment decisions made during the initial surgery (e.g. meniscus and articular cartilage treatments.)\n\nPrimary outcome measures will be the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and stiffness subscales and joint space width measured on weight-bearing radiographs.\n\nSecondary outcome measures will include the knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS) and Kellgren-Lawrence grading from weight-bearing radiographs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants enrolled in the Multicenter Orthopaedic Outcomes Network cohort by one of three 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 in St. Louis), or Dr. Matthew Matava (Washington University in St. Louis)\n* 14-55 years of age at the time of follow-up\n\nExclusion Criteria:\n\n* less than 14 years or greater than 55 years\n* non-active or unable to participate for health reasons'}, 'identificationModule': {'nctId': 'NCT00478894', 'acronym': 'MOON-Onsite', 'briefTitle': 'Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): Onsite Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Multicenter Orthopaedic Outcomes Network (MOON) Anterior Cruciate Ligament (ACL) Reconstruction (ACLR): Onsite Follow-up', 'orgStudyIdInfo': {'id': '070264'}, 'secondaryIdInfos': [{'id': '5R01AR053684', 'link': 'https://reporter.nih.gov/quickSearch/5R01AR053684', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Kurt P Spindler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic / Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kurt P. Spindler', 'investigatorAffiliation': 'Vanderbilt University'}}}}