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Multicenter Orthopaedics Outcomes Network for ACL Reconstructions

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v20

  2. Notable

    Primary completion date: Dec 2026 to Dec 2027

    Completion date: Dec 2027 to Dec 2028

    Study Statusv19

  3. Notable

    Primary completion date: May 2021 to Dec 2026

    Trial status: Completed to Active, Not Recruiting; Completion date: Dec 2021 to Dec 2027; Eligibility criteria shortened, about 36 words; and 2 more

    Show all 6 changes in this update
    • Notable Primary completion date: May 2021 to Dec 2026
    • Minor Trial status: Completed to Active, Not Recruiting
    • Minor Completion date: Dec 2021 to Dec 2027
    • Minor Eligibility criteria shortened, about 36 words
      Show what changed
      Inclusion Criteria: - All ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites. Between 10 and 33 years of age Injured while playing a sport Normal contralateral leg (no previous surgeries) Exclusion Criteria: Persons undergoing a simultaneous bilate [...] construction Patients less than 10 years old and older than 3380 years old patients not injured while playing a sport (e.g., MVA, ADL) Patients unwilling or unable to complete their repeatfollow-up questionnaire 2, 6, and 10 years after their initial visit.
    • Minor Secondary endpoints: details revised at 1 of 1 entry
    • Minor Study description revised
      Show what changed
      [...] M 1. To identify risk factors for reduced quality of life 2-1020 yrs post-ACLR, from information available at the time of su [...] ify risk factors for symptoms and signs of osteoarthritis 2-1020 years post-ACLR, from information available at the time of [...]

    Study Status, Study Description, Outcome Measures, Eligibilityv18

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v17

  5. Minor

    Study sites revised (8)

    Show what changed: Study sites
    Vanderbilt University Medical Center

    Study Status, Contacts/Locationsv16

Show 14 earlier versions

  1. Minor

    Trial status: Active, Not Recruiting to Completed

    Enrollment target: estimated 5000 to confirmed 3294; Primary completion date changed from estimate of Dec 2023 to May 2021; Study completion date changed from estimate of Dec 2024 to Dec 2021

    Study Status, Study Designv15

  2. Minor

    2 amendments

    2 re-verifications since 2020-04-23, no change to tracked fields

    v13-v14

  3. Minor

    Study sites: 10 to 8

    Study Status, Contacts/Locationsv12

  4. Notable

    Lead sponsor: Vanderbilt University to Vanderbilt University Medical Center

    Study sites: 9 to 10

    Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locationsv11

  5. Notable

    Primary completion date: Dec 2016 to Dec 2023

    Completion date: Dec 2017 to Dec 2024; Start date: Jan 2007 to Jan 2002

    Study Status, Sponsor/Collaborators, IPDSharingv10

  6. Minor

    Study description expanded, about 3 words

    Show what changed: Study description
    [...] including the characteristics of the patients (age, gender, BMIbody mass index, activity level, clinical knee alignment) and their injurie [...]

    Study Status, Study Description, Eligibilityv9

  7. Minor

    Trial status: Enrolling by Invitation to Active, Not Recruiting

    Study Statusv8

  8. Minor

    Primary completion date: Dec 2016

    Completion date: Dec 2016 to Dec 2017; Study description expanded, about 4 words

    Show what changed: Study description
    [...] nical outcomes (e.g.,OA and incidence of additional surgery)2 to 10 years after a patient's ACL reconstruction. AIM 1. To identify risk factors for reduced quality of life 2-10 yrs post-ACLR, from information available at the time of su [...] ctivity level, clinical knee alignment) and their injuries ("pop" heard at the time of injury, concurrent meniscus, articular cartilage, and collateral lig [...] treatment decisions made during the initial surgery (e.g., graft choice, meniscus and articular cartilage treatments). AIM 2. To iden [...] ify risk factors for symptoms and signs of osteoarthritis 2-yrs10 years pos [...]

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Outcome Measuresv7

  9. Minor

    Eligibility criteria expanded, about 21 words

    Show what changed: Eligibility criteria
    [...] tion at one of the participating MOON sites. Between 10 and 8533 years of age Injured while playing a sport Normal contralateral leg (no previous surgeries) Exclusion Criteria: Persons undergoing a simultaneous bilate [...] construction Patients less than 10 years old and older than 8533 years old patients not injured while playing a sport (e.g., MVA, ADL) Patients unwilling or unable to complete their repeat questionnaire 2,6, and 10 years after their initial visit.

    Study Identification, Study Status, Conditions, Eligibilityv6

  10. Minor

    Collaborators: 1 to 2

    Show what changed: Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    Study Identification, Study Status, Sponsor/Collaboratorsv5

  11. Minor

    Eligibility criteria shortened, about 14 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: All ACL-deficient candidates scheduled for either a unilateral, primary ACL reconstruction at one of the participating MOON sites or a revision ACL reconstruction at one of the participating MARS sites. Between 10 and 85 years of age Exclusion Criteria: Persons [...]

    Study Status, Eligibilityv4

  12. Minor

    Eligibility criteria shortened, about 9 words

    Study title shortened, about 1 word

    Show what changed: Eligibility criteria
    Inclusion Criteria: All ACL-deficient candidates scheduled for either a unilateral, primary ACL reconstruction at one of the participating MOON sites (Clevelandor Clinic,a Vanderbiltrevision University,ACL Ohioreconstruction Stateat University, Universityone of Iowa,the Washingtonparticipating UniversityMARS at Stsites. Louis, Hospital for Special Surgery, University of Colorado) Between 10 and 85 years of age Exclusion Criteria: Persons [...]
    Show what changed: Study title
    Multicenter Orthopaedics Outcomes Network (MOON) for ACL Reconstructions

    Study Identification, Study Status, Eligibilityv3

  13. Minor

    Trial status: Recruiting to Enrolling by Invitation

    Site details revised at 9 of 9 sites

    Study Status, Sponsor/Collaborators, Study Design, Eligibility, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to determine the effect of modifiable risk factors on knee function, osteoarthritis, and re-rupture of the anterior cruciate ligament (ACL) following ACL reconstruction.
Trial Details
NCT Number NCT00463099
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions Rupture of Anterior Cruciate Ligament
Enrollment 3,294 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov