Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823727
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-04-10
Brief Title:
Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling Functional Outcomes and Wound Healing After Total Knee Arthroplasty TKA
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling Functional Outcomes and Wound Healing After Total Knee Arthroplasty TKA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 inclusionexclusion 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 inclusionexclusion 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 23 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 participants 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
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 23 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 participants 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
Detailed Description:
UAMS Orthopedic Clinic personnel will monitor the clinic logs for prospective participants meeting the inclusionexclusion criteria of the study notifying the study Principal Investigator PI of potential study participants The PI will meet with the with interested participant to obtain consent virtually via REDCap prior to scheduling baseline visit week 0 at the UAMS Reynolds Institute on Aging RIOA The potential study participant will be allowed as much time as needed to be comfortable in their decision to participate in the study
For tissue specimen collection during TKA the PI will attend the surgery collecting samples of the ACL synovial fluid and bone fragments as they are removed and would otherwise be discarded by the surgeon Blood will also be collected by the anesthesiologist after line placement in the operating room Tissue samples will be prepared as described in the Specimen Handling and Storage Section and taken to the PIs laboratory the Center for Translational Research in Aging and Longevity CTRAL located on the 7th floor of the UAMS RIOA a secured access floor
Study Visits Week 0 Baseline
Informed Consent executed electronically
Randomization Excel Randomization Function
Baseline assessments CTRAL Knee Injury and Osteoarthritis Outcome Score KOOS Veterans RAND 12 VR-12 Profile of Mood States POMS Physical Activity Pain Dietary Intake 3-Day Food Log Dual-energy X-ray absorptiometry DXA scan - bone density both hips and lumbar spine Dual-energy X-ray absorptiometry DXA scan - body composition Bioelectrical impedance analysis BIA Scan - body water Hand grip strength Collecting blood sample 4 mL x 1 for serum and 4 mL x 1 for plasma
Treatment 10 g Collagen Peptides or Placebo Weeks 0 - 24 Deuterated water D2O Weeks 6 - 8 Week 4
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance Week 8
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance
Total Knee Arthroplasty Collect Anterior Cruciate Ligament Collect Synovial Fluid Collect blood sample 4 mL x 1 for serum and 4 mL x 1 for plasma
Physical Therapy three times weekly Weeks 8 - 24 Pain Range of Motion ROM for flexion and extension of surgery knee KOOS Jr Week 10
Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 12
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance Week 14
Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 16
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance
Physical Therapy Follow Up Pain ROM KOOS Jr Functional Measures Battery Week 20
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance
Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 24 Final Assessments - Stop Treatment
CTRAL Knee Injury and Osteoarthritis Outcome Score KOOS Veterans RAND 12 VR-12 Profile of Mood States POMS Pain Activity DXA - bone mineral density both hips and lumbar spine DXA - body composition Grip Strength Compliance 3-Day Food Log
For tissue specimen collection during TKA the PI will attend the surgery collecting samples of the ACL synovial fluid and bone fragments as they are removed and would otherwise be discarded by the surgeon Blood will also be collected by the anesthesiologist after line placement in the operating room Tissue samples will be prepared as described in the Specimen Handling and Storage Section and taken to the PIs laboratory the Center for Translational Research in Aging and Longevity CTRAL located on the 7th floor of the UAMS RIOA a secured access floor
Study Visits Week 0 Baseline
Informed Consent executed electronically
Randomization Excel Randomization Function
Baseline assessments CTRAL Knee Injury and Osteoarthritis Outcome Score KOOS Veterans RAND 12 VR-12 Profile of Mood States POMS Physical Activity Pain Dietary Intake 3-Day Food Log Dual-energy X-ray absorptiometry DXA scan - bone density both hips and lumbar spine Dual-energy X-ray absorptiometry DXA scan - body composition Bioelectrical impedance analysis BIA Scan - body water Hand grip strength Collecting blood sample 4 mL x 1 for serum and 4 mL x 1 for plasma
Treatment 10 g Collagen Peptides or Placebo Weeks 0 - 24 Deuterated water D2O Weeks 6 - 8 Week 4
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance Week 8
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance
Total Knee Arthroplasty Collect Anterior Cruciate Ligament Collect Synovial Fluid Collect blood sample 4 mL x 1 for serum and 4 mL x 1 for plasma
Physical Therapy three times weekly Weeks 8 - 24 Pain Range of Motion ROM for flexion and extension of surgery knee KOOS Jr Week 10
Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 12
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance Week 14
Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 16
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance
Physical Therapy Follow Up Pain ROM KOOS Jr Functional Measures Battery Week 20
Virtual
Knee Injury and Osteoarthritis Outcome Score KOOS
Veterans RAND 12 VR-12
Profile of Mood States POMS
Physical Activity
Pain 3-day food log Compliance
Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 24 Final Assessments - Stop Treatment
CTRAL Knee Injury and Osteoarthritis Outcome Score KOOS Veterans RAND 12 VR-12 Profile of Mood States POMS Pain Activity DXA - bone mineral density both hips and lumbar spine DXA - body composition Grip Strength Compliance 3-Day Food Log
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None