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Initial Graft Tension and ACL Surgery

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Publications: 28 to 29v23 See this version in full on ClinicalTrials.gov ↗
  2. Re-verified, no change to tracked fieldsv22
  3. Results first posted: Dec 18, 2024 Primary endpoints: 1 to 3 · Secondary endpoints: 9 to 21 · Publications: 27 to 28 · 1 morev21 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

    See this version in full on ClinicalTrials.gov ↗

  4. 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 27v20 Show 2 more changesShow less
    • Primary and study completion dates changed from estimate of May 2024 to Feb 29, 2024
    • Publications: 26 to 27

    See this version in full on ClinicalTrials.gov ↗

  5. Publications: 25 to 26v19 See this version in full on ClinicalTrials.gov ↗
Show 17 earlier versionsHide 17 earlier versions
  1. Publications: 22 to 25v18 See this version in full on ClinicalTrials.gov ↗
  2. Publications: 21 to 22v17 See this version in full on ClinicalTrials.gov ↗
  3. Primary and study completion dates: May 2020 to May 2024 Secondary endpoints: details revised at 9 of 9 entries · Study description expanded, about 1 wordv16 Show 2 more changesShow less
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Publications: 20 to 21v15 See this version in full on ClinicalTrials.gov ↗
  5. Publications: 18 to 20v14 See this version in full on ClinicalTrials.gov ↗
  6. Primary endpoints: 3 to 1 Secondary endpoints: 5 to 9 · Publications: details revised at 2 of 18 entries · Study arms: 2 to 3v13 Show 3 more changesShow less
    • Secondary endpoints: 5 to 9
    • Publications: details revised at 2 of 18 entries
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  7. Re-verified, no change to tracked fieldsv12
  8. 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 wordv11 Show 3 more changesShow less
    • Secondary endpoints: details revised at 5 of 5 entries
    • Publications: 15 to 18
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Publications: details revised at 1 of 15 entriesv10
  10. Publications: 12 to 15v9 See this version in full on ClinicalTrials.gov ↗
  11. Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to Rhode Island Hospital Primary endpoints: 4 to 3 · Secondary endpoints: 4 to 5 · Collaborators expanded, about 10 words · 2 morev8 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

    See this version in full on ClinicalTrials.gov ↗

  12. Publications: details revised at 7 of 10 entriesv7
  13. Primary and study completion dates: May 2009 to May 2014 Publications: 3 to 10 · Study description expanded, about 2 wordsv6 Show 2 more changesShow less
    • Publications: 3 to 10
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  14. Re-verified, no change to tracked fieldsv5
  15. Primary endpoints revised (4) Enrollment target: estimated 162 to confirmed 168 · Primary and study completion dates: May 2009 · Secondary endpoints revised (4) · 2 morev4 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

    See this version in full on ClinicalTrials.gov ↗

  16. Trial status: Recruiting to Active, Not Recruiting Site details revised at 2 of 2 sitesv3 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  17. Re-verified, no change to tracked fieldsv2
  1. 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 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 Anterior Cruciate Ligament Rupture
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov