Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
Healthy Volunteers
NCT05823727

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

Led by University of Arkansas · Updated on 2026-04-03

44

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

Sponsors

U

University of Arkansas

Lead Sponsor

T

Tessenderlo Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 50 to 75 years
  • Body mass index between 20.0 and 39.9 kg/m2
  • Diagnosed with primary osteoarthritis
  • Scheduled for total knee arthroplasty (TKA) at UAMS within two months
  • Live near Little Rock and plan to attend physical therapy in Little Rock
  • COVID-19 negative or asymptomatic
Not Eligible

You will not qualify if you...

  • Previous serious knee injury or surgery to the ACL in the knee planned for TKA
  • Females who are not postmenopausal
  • Hormone replacement therapy within the last 12 months
  • Active blood-borne infectious disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72201

Actively Recruiting

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Research Team

S

Shiloah Kviatkovsky

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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