Phase 3
N=64
Effect of Different Injection Regimens of Autologous Conditioned Plasma for Knee Osteoarthritis
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03889925 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Western Ontario and McMaster University's Osteoarthritis Index (WOMAC) — 24.9; 22.4; 26.1; 22.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hyaluronan (Drug); Autologous conditioned plasma (Biological)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Andrews Research & Education Foundation
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario and McMaster University's Osteoarthritis Index (WOMAC) |
24.9; 22.4; 26.1; 22.3; 21.9; 22.5 | — |
| PRIMARY International Knee Documentation Committee Subjective Knee Evaluation Form |
50.1; 53.7; 50.4; 56.9; 53.1; 53.1 | — |
| PRIMARY Knee Injury and Osteoarthritis Outcome Score |
59.4; 62.7; 59; 62.9; 64.2; 62.5 | — |
Summary
The clinical efficacy of hyaluronic acid or corticosteroid injections has been reported, but effects are short lived. This has led to the development of additional injection options such as autologous derived blood products which have been documented to alleviate symptoms related to knee osteoarthritis, with recent comparative studies suggesting a greater, long-lasting effect with these blood derived products like platelet rich plasma (PRP) [2-8]. One clinically-developed preparation of platelet rich plasma, named autologous conditioned plasma (ACP), has randomized controlled trial data proving efficacy [4,9]. Clinical use of platelet rich plasma for knee arthritis typically involves a 3-injection series over 3 weeks, i.e. an injection once a week for three weeks. The main objective of this study is to determine if hyaluronic acid (HA) injected at the same time as autologous conditioned plasma (ACP), a leukocyte-poor platelet rich plasma product, will improve the performance of ACP in the treatment of symptomatic knee osteoarthritis. It is hypothesized that the injection of hyaluronic acid will improve the efficacy of ACP.
Eligibility Criteria
Inclusion Criteria
- Patients between the ages of 30 and 80
- Documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the involved knee (Kellgren-Lawrence grades 1-4)
- Patients must have a documented diagnosis of primary OA for at least 6 weeks.
Exclusion Criteria
- Patients who have had viscosupplementation in the involved knee in the past 6 months.
- Any patient who has had a corticosteroid injection in any joint within 3-months prior to screening will be excluded.
- Patients with gout or rheumatologic disease will be excluded. Patients who have had a previous negative experience with HA.
- Any patient who will have difficulty obtaining internet access, does not have an active e-mail address, or is unable to comprehend study documents or give informed consent will be excluded.
Data sourced from ClinicalTrials.gov (NCT03889925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.