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Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing After Total Knee Arthroplasty (TKA)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion pushed from Jan 1, 2027 to Jun 1, 2027
    • Start date changed from estimate of Apr 1, 2026 to May 1, 2026
    v20
  2. Notable Recruitment opened
    • Start date: Feb 1, 2026 to Apr 1, 2026
    • Study sites: 0 to 1
    v19
  3. Notable Primary completion date: Jun 1, 2026 to Jan 1, 2027
    • Start date: Jan 1, 2026 to Feb 1, 2026
    • Study completion date: Jun 1, 2026 to Jun 1, 2027
    v18
  4. Notable Start date: Sep 1, 2025 to Jan 1, 2026v17
  5. Notable Start date: Jul 20, 2025 to Sep 1, 2025v16
Show 14 earlier versionsHide 14 earlier versions
  1. Notable Primary and study completion dates: Jun 1, 2025 to Jun 1, 2026
    • Start date: Jun 1, 2025 to Jul 20, 2025
    v15
  2. Notable Start date: Apr 1, 2025 to Jun 1, 2025v14
  3. Notable Start date: Feb 1, 2025 to Apr 1, 2025v13
  4. Notable Start date: Dec 1, 2024 to Feb 1, 2025v12
  5. Notable Start date: Oct 1, 2024 to Dec 1, 2024v11
  6. Minor Study Status, Oversight, Contacts/Locationsv10
  7. Notable Start date: Aug 1, 2024 to Oct 1, 2024v9
  8. Notable Start date: Jun 1, 2024 to Aug 1, 2024v8
  9. Notable Primary completion date: Jun 1, 2024 to Jun 1, 2025
    • Start date: Feb 1, 2024 to Jun 1, 2024
    v7
  10. Notable Start date: Dec 1, 2023 to Feb 1, 2024v6
  11. Notable Start date: Sep 1, 2023 to Dec 1, 2023v5
  12. Notable Start date: Jun 1, 2023 to Sep 1, 2023v4
  13. Minor 2 versions Re-verified since Apr 25, 2023, no change to tracked fieldsv2-v3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Recruiting will be performed via checking the calendar for scheduled TKA procedures in the \> 8 weeks by clinical staff in the UAMS orthopedic clinic. Clinic staff will look for basic inclusion/exclusion criteria in the EMR for those patients. Clinic staff will either contact directly or send contact information to the PI of this study to contact for recruitment purposes. During the initial phone call, study staff will review inclusion/exclusion criteria to verify eligibility and will discuss study specifics and send a link to the current informed consent form located on the UAMS REDCap server. If the subject wishes to enroll, they will do so via electronic consent through REDCap. REDCap will notify study staff that the consent was signed, then study staff will schedule initial baseline study visit. Visit 1 and Visit 2 will take place at the RIOA at week 0 and week 24, respectively. Participants will report having fasted overnight, and having abstained from alcohol for 24 hours, vigorous exercise for 24 hours, and caffeine for 12 hours. A blood sample will be drawn upon arrival, followed by a DXA scan to measured bone mineral density (BMD) in both hips and lumbar spine, and for body composition, using CTRAL equipment. Participants will also undergo a body water assessment using BIA to determine deuterium dose. Bilateral handgrip strength will be measured via Dynamometer. Participants will fill out a 3-Day food log, physical activity questionnaire, pain scale, KOOS, VR-12, and the POMS. Participants will be given an 8-week supply of their respective treatment supplement, with instructions and a compliance log (to be filled out monthly). Participants will also be given their dose of deuterium oxide (D2O) to be ingested according to instruction at week 2\&3, prior to TKA (week 4). Tissue samples for ACL, bone fragments, and synovial fluid will be collected by the PI during TKA surgery. All other assessments will be taken during clinical visits with the participant's physical therapists and their orthopedic doctors. The PI will attend some of these visits to assess wound healing, administer handgrip strength assessment, and to replenish participant treatment supply.
Trial Details
NCT Number NCT05823727
Lead Sponsor University of Arkansas
Collaborators: Tessenderlo Group
Conditions
(from sponsor)
Knee Osteoarthritis
Related terms Osteoarthritis, Osteoarthritis, Knee
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov