Foot & Ankle International - June 2017 - 597
Fukawa et al
597
Table 1. PRP Quality.
Author
Battaglia et al.6
Görmeli et al.18
Mei-Dan et al.26
Filardo et al.14
Kon et al.22
Our study
PRP system
Centrifugation
Plate
Concentration (fold)
WBC
Activationa
NR
Smart-PRePR2b
PRGF System IIc
Custom
Custom
Custom
Double spin
NR
Double spin
Double spin
Double spin
Double spin
6
5.2
2-3
5
6
5.1
Yes
NR
No
Yes
Yes
No
Yes
NR
Yes
NR
Yes
Yes
Abbreviations: PRP, platelet rich plasma; WBC, white blood cell; NR, not reported.
a
PRPs were activated by using calcium chloride in all reports.
b
Smart-PRePR2 system (Harvest Autologous Hemobiologics, Norwell, MA)
c
PRGF System II (BTI, Vitoria, Spain)
established.1 The development of an effective conservative
treatment that both preserves joint function and alleviates
pain would contribute to an improvement of patients' quality of life.
Platelet-rich plasma (PRP) is an autologous blood product obtained by centrifugation of autologous blood and contains a high concentration of platelets and numerous growth
factors in its alpha granules. Various growth factors and
cytokines are released from the degranulated platelets,
which play a crucial role in joint homeostasis and healing
processes.12 For example, TGF-β is widely considered as a
promoter for enhancing matrix production and the proliferation of chondrocytes. It downregulates the gene expression
of type I collagen and simultaneously upregulates the gene
expression of type II collagen and aggrecan.44 The concentration of platelets is a commonly used parameter to assess
PRP quality. The rates are quite varied among studies, ranging from 2- to 6-fold,15 and are dependent on the PRP preparation method, including the type of PRP preparation kit,
centrifugation system, and number of centrifugation steps
(Table 1). As a result, no consensus has been reached on the
optimal concentration and preparation method.2 Recently,
an intra-articular injection of PRP has become a treatment
option for OA. Intra-articular injections of PRP may have
beneficial effects in the treatment of mild to moderate knee
OA as compared with hyaluronic acid injections.20,21
Furthermore, the positive effect of PRP injections has been
shown in primary hip OA.6
Regarding intra-articular injections of PRP in the ankle
joint, an injection, of which the mean concentration rate of
platelets was 2- to 3-fold, in patients with osteochondral
lesions of the talus alleviated pain and improved joint
function.26 In addition, PRP injections in addition to
microfracture surgery improved the clinical outcomes of
osteochondral lesions of the talus as compared with microfracture alone.18 The concentration rate of platelets used in
this study was 5.2-fold. However, no studies have investigated the effect of intra-articular injections of PRP in
patients with ankle OA. The purpose of this study was to
assess the safety and efficacy of an intra-articular injection
of PRP in patients with primary varus ankle OA during a
6-month follow-up period.
Methods
Inclusion and Exclusion Criteria
The present study was conducted with the approval of the
ethics committee of Chiba University Hospital. Informed
consent was obtained from all patients. Patients with primary varus ankle OA who did not respond to at least 6
months of conservative therapy, including physical therapy, orthoses such as insoles and braces, shoe modification, and medication, were recruited between August
2013 and December 2014. The diagnosis of ankle OA
was made by 3 orthopaedic surgeons who were not
involved in the injection of PRP or clinical assessments.
The diagnostic criteria were a history of ankle pain or
swelling of the ankle for at least 6 months and OA
changes of the ankle on weightbearing anteroposterior
and lateral radiographs assessed in accordance with the
Tanaka/Takakura classification.5,33 We included patients
with primary varus OA of the ankle, and patients with a
history of ankle fractures were excluded. Although traumatic OA is reported to be the most common cause of
ankle OA,5 primary varus OA was the most frequent etiology in our clinic probably because of the varus tibial
plafond in the Japanese population.31,34 The inclusion
and exclusion criteria are described in Table 2.
Sample Size
The sample size was determined based on the study by MeiDan et al.25,26 In addition, the 2-point reduction in the visual
analog scale (VAS) score at 24 weeks was assumed as the
minimal clinically important difference.26 To achieve a
power of 80% with the level of significance at .05, the
required sample size was 16. With the assumption that the
dropout rate was 20%, the total sample size to be enrolled
was 20 patients.
Table of Contents for the Digital Edition of Foot & Ankle International - June 2017
Contents
Foot & Ankle International - June 2017 - Intro
Foot & Ankle International - June 2017 - Cover1
Foot & Ankle International - June 2017 - Cover2
Foot & Ankle International - June 2017 - i
Foot & Ankle International - June 2017 - ii
Foot & Ankle International - June 2017 - Contents
Foot & Ankle International - June 2017 - iv
Foot & Ankle International - June 2017 - v
Foot & Ankle International - June 2017 - vi
Foot & Ankle International - June 2017 - vii
Foot & Ankle International - June 2017 - viii
Foot & Ankle International - June 2017 - 1A
Foot & Ankle International - June 2017 - 1B
Foot & Ankle International - June 2017 - ix
Foot & Ankle International - June 2017 - x
Foot & Ankle International - June 2017 - xi
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Foot & Ankle International - June 2017 - 2A
Foot & Ankle International - June 2017 - 2B
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Foot & Ankle International - June 2017 - 3A
Foot & Ankle International - June 2017 - 3B
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Foot & Ankle International - June 2017 - CT1
Foot & Ankle International - June 2017 - CT2
Foot & Ankle International - June 2017 - 4A
Foot & Ankle International - June 2017 - 4B
Foot & Ankle International - June 2017 - Cover3
Foot & Ankle International - June 2017 - Cover4
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