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Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717559
Recruitment Status : Enrolling by invitation
First Posted : March 23, 2016
Last Update Posted : April 27, 2020
Sponsor:
Collaborators:
The Cleveland Clinic
Ohio State University
Information provided by (Responsible Party):
Kurt P. Spindler, Vanderbilt University Medical Center

Brief Summary:
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.

Condition or disease
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Detailed Description:

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.

Primary 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).

Secondary outcome measures will include the knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS).

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Study Type : Observational
Estimated Enrollment : 434 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up
Study Start Date : March 2016
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Joint space width measured on weight-bearing radiographs [ Time Frame: 10 years after ACL reconstruction surgery ]
  2. Pain subscale of the Knee Injury and Osteoarthritis Score (KOOS). [ Time Frame: 10 years after ACL reconstruction surgery ]

Secondary Outcome Measures :
  1. Knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS) [ Time Frame: 10 years after ACL reconstruction surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants enrolled in the Multicenter Orthopaedic Outcomes Network cohort by one of study site surgeons and meeting eligibility criteria
Criteria

Inclusion Criteria:

  • Had primary unilateral ACL reconstruction performed by Dr. Kurt Spindler (Vanderbilt University), Dr. Christopher Kaeding (The Ohio State University), Dr. Rick Parker (Cleveland Clinic), or Dr. Jack Andrish (Cleveland Clinic).
  • Participated in the 2 yr onsite visit

Exclusion Criteria:

  • Non-active or unable to participate for health reasons
  • Cannot return to the original site of testing
  • Unable to be consented
  • Insufficient initial documentation
  • Cannot be contacted by phone
  • History of total knee arthroplasty on either knee
  • History of revision ACLR on the knee for which the patient was originally enrolled
  • History of intra-articular knee infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717559


Sponsors and Collaborators
Vanderbilt University Medical Center
The Cleveland Clinic
Ohio State University
Investigators
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Principal Investigator: Kurt P Spindler, MD Vanderbilt University / The Cleveland Clinic Foundation
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Responsible Party: Kurt P. Spindler, Adjoint Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02717559    
Other Study ID Numbers: 160049
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kurt P. Spindler, Vanderbilt University Medical Center:
Anterior cruciate ligament / injuries
Anterior cruciate ligament / surgery
knee injuries / surgery
outcomes research
prospective studies
osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Collagen Diseases
Arthritis
Connective Tissue Diseases