Initial Graft Tension and ACL Surgery

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Publications: 28 to 29v23
  2. Re-verified, no change to tracked fieldsv22
  3. Notable Results first posted: Dec 18, 2024v21 Show 4 more changesShow less
    • Primary endpoints: 1 to 3
    • Secondary endpoints: 9 to 21
    • Publications: 27 to 28
    • Study description expanded, about 3 words
  4. Minor Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of May 2024 to Feb 29, 2024
    • Publications: 26 to 27
    v20
  5. Minor Publications: 25 to 26v19
Show 17 earlier versionsHide 17 earlier versions
  1. Minor Publications: 22 to 25v18
  2. Minor Publications: 21 to 22v17
  3. Notable Primary and study completion dates: May 2020 to May 2024
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description expanded, about 1 word
    v16
  4. Minor Publications: 20 to 21v15
  5. Minor Publications: 18 to 20v14
  6. Notable Primary endpoints: 3 to 1
    • Secondary endpoints: 5 to 9
    • Publications: details revised at 2 of 18 entries
    • Study arms: 2 to 3
    v13
  7. Re-verified, no change to tracked fieldsv12
  8. Notable Primary and study completion dates: May 2014 to May 2020
    • Secondary endpoints: details revised at 5 of 5 entries
    • Publications: 15 to 18
    • Study description expanded, about 1 word
    v11
  9. Minor Publications: details revised at 1 of 15 entriesv10
  10. Minor Publications: 12 to 15v9
  11. Notable Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to Rhode Island Hospitalv8 Show 5 more changesShow less
    • Primary endpoints: 4 to 3
    • Secondary endpoints: 4 to 5
    • Collaborators expanded, about 10 words
    • Publications: 10 to 12
    • Study description expanded, about 3 words
  12. Minor Publications: details revised at 7 of 10 entriesv7
  13. Notable Primary and study completion dates: May 2009 to May 2014
    • Publications: 3 to 10
    • Study description expanded, about 2 words
    v6
  14. Re-verified, no change to tracked fieldsv5
  15. Notable Primary endpoints revised (4)v4 Show 5 more changesShow less
    • Enrollment target: estimated 162 to confirmed 168
    • Primary and study completion dates: May 2009
    • Secondary endpoints revised (4)
    • Study title shortened, about 7 words
    • Study arms: 0 to 2
  16. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v3
  17. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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 anterior cruciate ligament (ACL) is one of four strong ligaments connecting the bones of the knee joint. If overstretched, the ACL can tear. Reconstruction of a torn ACL is now a common surgical procedure. The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time. The purpose of this study is to determine the effect of initial graft tension set during ACL reconstruction surgery on the progression of knee arthritis over at least a 15-year period.
Trial Details
NCT Number NCT00434837
Lead Sponsor Rhode Island Hospital
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions
(from sponsor)
Anterior Cruciate Ligament Rupture
Related terms Anterior Cruciate Ligament Injuries, Osteoarthritis
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov