Podium Presentation Platelet Rich Plasma and Growth factors

12.4.4 - Duration effects of a single intra-articular injection of Autologous Protein Solution (APS) in patients with knee osteoarthritis (OA)

Presentation Number
12.4.4
Presentation Topic
Platelet Rich Plasma and Growth factors
Lecture Time
17:27 - 17:36
Session Name
Session Type
Free Papers
Corresponding Author
  • E. Kon (Milano, IT)
Authors
  • E. Kon (Milano, IT)
  • P. Verdonk (Gent-Zwijnaarde, BE)
  • L. Engebretsen (Oslo, NO)
  • S. Nehrer (Krems, AT)
  • A. Di Martino (Bologna, IT)
  • G. Filardo (Bologna, IT)
Disclosure
L.E, Arthrex, Biomet, Smith & Nephew, research support; Arthrex, consultant; iBalance, shareholder G.F, Cartiheal, Finceramica, GreenBone, presenter; IGEA, BIOMET, Kensey Nash, Finceramica, Fidia, Cartiheal, EON, research support E.K, Biomet, Fidia, Fince

Abstract

Purpose

Autologous anti-inflammatories (AAI) are a class of blood-derived products with high concentrations of anti-inflammatory cytokines that are currently being investigated for the treatment of mild to moderate knee osteoarthritis (OA) to determine if they can ameliorate symptoms longer or better than traditional intra-articular injections such as hyaluronic acid (HA) and steroids. The purpose of this evaluation is to determine the duration of effect from a single injection of APS before patients elect a new treatment course.

Methods and Materials

Forty-six patients underwent a 2:1 randomization process to either one single injection of APS (n=31) or saline (n=15) (NCT02138890). APS was prepared with the nSTRIDE APS Kit (Zimmer Biomet). The 12 month double-blind outcomes of the double-blind portion of the trial were previously published. The APS cohort was asked to participate in unblinded long-term follow-up. Efficacy endpoints of pain and function over time (WOMAC LK 3.1, KOOS, and VAS) were measured as a change from baseline to each time point. Quality of life (SF-36), OMERACT-OARSI responder criteria, rescue medication usage, as well as yearly x-rays and 24 month MRI imaging were completed.

Results

Survivorship of the APS cohort that agreed to long-term follow-up was 71% at 3 years. At 36 months, the mean WOMAC Pain improvement was 70%(Figure 2)(7.8 ± 4.0) in the APS cohort, which was a significant improvement compared to the baseline score(p<0.0001). APS cohort patients also showed a statistically significant improvement in their KOOS pain score (114%,33.3 ± 22.0; p<0.0001) and VAS pain score (42.7%, 2.0 ± 3.3; p=0.0012).

Conclusion

Intra-articular injections of APS for mild to moderate knee OA was safe and a portion of patients continue to have pain relief 3 years after a single injection. Clinical investigation (NCT03182374) to determine the long-term efficacy compared to a single injection hyaluronic acid is currently ongoing.

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