NCT05823727 · University of Arkansas
Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing After Total Knee Arthroplasty (TKA)
What this study 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/reasons someone cannot join 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and Females, 50 to 75 years old
- With a body mass index of 20.0 to 39.9 kg/m2
- Diagnosed with primary osteoarthritis
- Scheduled for a TKA at UAMS (two months prior to surgery) at UAMS
- Live near Little Rock and scheduled to attend physical therapy in Little Rock
- COVID-19 negative and/or asymptomatic.
Exclusion criteria
- Previously sustained serious knee injury or surgery to ACL in TKA knee
- Females not postmenopausal
- Having undergone hormone replacement therapy in the last 12 months.
- Active diagnosis of blood borne infectious disease
Where
- Little Rock, Arkansas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations