Osteo Arthritis Knee Clinical Trial
Official title:
Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis: A Randomized Controlled Pilot Trial
The overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin K supplementation on knee osteoarthritis progression and related functional decline. To address critical parameters required to design this larger RCT, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee OA and low baseline vitamin K status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. Specifically, we will: (1) compare the effects of 1 mg/day phylloquinone vs. placebo on the non-functional circulating form of MGP; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the Osteoarthritis Research Society International (OARSI)-recommended performance-based tests of physical function in adults with low vitamin K status and mild to moderate knee osteoarthritis. We will also obtain preliminary data on the distribution of MGP genotype at two clinical sites for effect size generation.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04040985 -
Legion Primary Safety and Efficacy
|
N/A | |
| Active, not recruiting |
NCT04525950 -
Robotized Navigation Compared to Conventional Technique in Total Knee Replacement
|
N/A | |
| Recruiting |
NCT04320914 -
High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis
|
N/A | |
| Completed |
NCT03886142 -
Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis
|
N/A | |
| Terminated |
NCT04072055 -
MOTO Post-marketing Surveillance Study
|
||
| Not yet recruiting |
NCT06385275 -
The Role of Vitamin K on Knee Osteoarthritis Outcomes
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05290818 -
Total Versus Robotic Assisted Unicompartmental Knee Replacement
|
N/A | |
| Withdrawn |
NCT03271229 -
Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee
|
Phase 2 | |
| Recruiting |
NCT05992038 -
Use of a Putty as Gap Filler in Open-wedge Osteotomy
|
N/A | |
| Recruiting |
NCT06066684 -
Pain Phenotyping in Knee OA: a Pilot Trial
|
||
| Completed |
NCT03847324 -
Physiotherapy and Therapeutic Education on Patients With Pain Catastrophism Scheduled for a Total Knee Arthroplasty
|
N/A | |
| Recruiting |
NCT05126485 -
Biofeedback Retention in Individuals With AKA
|
Early Phase 1 | |
| Completed |
NCT04956393 -
The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study
|
N/A | |
| Recruiting |
NCT04541342 -
Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy
|
N/A | |
| Completed |
NCT04391842 -
Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis
|
Phase 1 | |
| Completed |
NCT03680807 -
Power Production in Older Adults With Knee Osteoarthritis
|
||
| Completed |
NCT03783455 -
Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis
|
N/A | |
| Not yet recruiting |
NCT06264362 -
Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
|
N/A | |
| Completed |
NCT05089253 -
Effect of Physical Therapy Modalities in Osteoarthritis
|
N/A | |
| Completed |
NCT04536519 -
Foot Wear Modification Along With Physical Therapy in Knee Osteoarthritis
|
N/A |