Intra-articular platelet-rich plasma (PRP) injections for treating knee pain associated with osteoarthritis of the knee in the Japanese population: a phase I and IIa clinical trial

Yu Taniguchi, Tomokazu Yoshioka, Akihiro Kanamori, Katsuya Aoto, Hisashi Sugaya, Masashi Yamazaki, Yu Taniguchi, Tomokazu Yoshioka, Akihiro Kanamori, Katsuya Aoto, Hisashi Sugaya, Masashi Yamazaki

Abstract

Intra-articular platelet-rich plasma (PRP) injection has been found to be effective for treating osteoarthritis in patients from Western countries; however, the safety and efficacy of PRP have not been sufficiently investigated in Japanese patients. The present study aimed to evaluate the safety and feasibility of intra-articular PRP injection in Japanese patients with knee osteoarthritis. PRP without white blood cells was prepared using a single-spin centrifuge (PRGF-Endoret; BTI Biotechnology Institute, Vitoria, Spain). A 6-mL PRP volume was injected in the knee joint three times at 1 week intervals. All patients were prospectively evaluated before intervention and at 1, 3, and 6 months after the treatment. Adverse events, the Visual Analog Scale (VAS) pain score, Japanese Knee Osteoarthritis Measure (JKOM) score and Japanese Orthopedic Association score were evaluated. Ten patients (all women; average age, 60.6 years) were treated. Only minor adverse events after injection were noted, and symptoms resolved within 48 hours after the injection. The average VAS pain scores were 71.6 mm and 18.4 mm at baseline and the 6-month follow-up, respectively (P < 0.05). At the 6-month follow-up, 80% of patients had a decrease in the VAS pain score of 50% or more. The average JKOM scores were 35.2 and 14.3 at baseline and at the 1-month follow-up, respectively (P < 0.05). Intra-articular PRP injection likely represents a safe treatment option for Japanese patients with mild-to-moderate knee osteoarthritis, and has the potential to relieve pain for up to 6 months, but further study is needed to verify the efficacy.

Keywords: intra-articular injection; knee osteoarthritis; platelet-rich plasma; treatment safety.

Figures

Fig. 1
Fig. 1
Platelet-rich plasma (PRP) preparation workflow (a) Centrifugation at 2100 rpm for 8 minutes using the single-spin system (PRGF System IV; BTI Biotechnology Institute, Vitoria, Spain). (b) Photograph of the blood-collecting tube after centrifugation and scheme for fraction separation. The safety margin was set to exclude red blood cells and white blood cells. The lower half of the supernatant was defined as PRP, while the upper half was defined as platelet-poor plasma (PPP). (c) Aspirating PPP and PRP using an exclusive pipette in a clean bench. (d) Under aseptic conditions, 6 mL of PRP were injected into the suprapatellar pouch using the superolateral approach.
Fig. 2
Fig. 2
Trends in the mean Visual Analog Scale (VAS) scores for pain recorded over a follow-up of six months. Ten patients with knee osteoarthritis received intra-articular injections with platelet-rich plasma, administered once per week for three weeks. VAS scores were assessed at baseline (before injection) and during subsequent follow-up visits. *P < 0.05.
Fig. 3
Fig. 3
Trends in the mean Japanese Knee Osteoarthritis Measure (JKOM) scores over a 6-month follow-up. Ten patients with knee osteoarthritis received intra-articular injections with platelet-rich plasma, administered once per week for three weeks. JKOM scores were assessed at baseline (before injection) and during subsequent follow-up visits. *P < 0.05.
Fig. 4
Fig. 4
Mean Japanese Orthopedic Association (JOA) scores. The patients with knee osteoarthritis received intra-articular injections with platelet-rich plasma, administered once per week for three weeks. JOA scores were assessed at baseline (before injection) and at the 6-month follow-up visit. Different categories are represented by different filling patterns. *P < 0.05. ROM, range of motion.

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