Collagen Peptide Supplement for Knee Osteoarthritis
Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing After Total Knee Arthroplasty (TKA)
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At a Glance
Age
50 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
University of Arkansas · Other
Who this trial is looking for
This trial is looking for adults aged 50 to 75 who are scheduled for knee replacement surgery. Participants will provide blood samples and undergo tests to assess their health before and after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am 50 to 75 years old.
I have a body mass index between 20.0 and 39.9.
I have been diagnosed with primary osteoarthritis.
I am scheduled for knee replacement surgery at UAMS.
I live near Little Rock and will attend physical therapy there.
I am COVID-19 negative and/or not showing symptoms.
You may not be able to join if
I have had a serious knee injury or surgery on my knee in the past.
I am a woman who is not postmenopausal.
I have undergone hormone replacement therapy in the last 12 months.
I have an active blood borne infectious disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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 Locations
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Eligibility Criteria
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
* CO…
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
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