FREE PAPER SESSION - Comparison of platelet rich plasma with steroids in OA knee - Dr Arjun MN
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Transcript of FREE PAPER SESSION - Comparison of platelet rich plasma with steroids in OA knee - Dr Arjun MN
IRACON 2016
Dr. Arjun MN, Dr Vivek VasdevDepartment of RheumatolgyArmy Hospital (Research & Referral), Delhi Cantt
Title
Comparative analysis of efficacy of intra articular autologous
platelet rich plasma (PRP) with steroids in osteoarthritis kneeA Prospective randomized comparative interventional study
Introduction
Osteoarthritis (OA) of the knee is one the most prevalent degenerative joint disease in the world affecting almost 13 % of patients aged >60 yrs
In India, the prevalence of OA knee ranges from 28.7-31.4 %
Main treatment option is surgery Cumbersome Associated with significant cost and potential morbidity.
Ref: Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013;21:1145–1153 Pal CP, Singh P, Chaturvedi S, Epidemiology of knee osteoarthritis in India and related factors. Indian J Orthop
2016;50:518-22
Background:
Evidence lacking regarding the amount and duration of efficacy of PRP
No consensus worldwide about standardization of PRP dosing or regimes
Weekly PRP injections require frequent visits to hospital and repeated
injections is inconvenient and have potential related side effects
Two 6 ml injection at 03 monthly intervals, represent an attractive
alternative to the current treatment regimen, reducing the number of
intra-articular injections and offers potential comfort and safety benefits
Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013; 41(2):356–364
Platelet Rich Plasma (PRP)
PRP is an autologous concentration of a high number of platelets in a small volume of plasma prepared by centrifugation of blood
PRP has been used in maxillofacial and plastic surgery > a decade. Presently, accepted in orthopaedics and sports medicine for treatment of tendinopathy and capsular relaxation in the shoulder.
Rationale for the use of PRP is to stimulate natural healing cascade and tissue regeneration by a “supraphysiologic” release of platelet-derived growth factors directly at the site of treatment
Ref: • Cerza F, Carni S, Carcangiu A, et al. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012; 40(12):2822–2827• Linda Mundy HealthPACT “ Brief Platelet-rich plasma for the treatment of knee osteoarthritis “ August 2013
Platelets structure and activation: Platelets contain significant amounts of cytokines and growth factors which are capable of stimulating cellular growth, vascularization, proliferation, tissue regeneration, and collagen synthesis.
Ref: Ryosuke Sakata, MD, and A. Hari Reddi, PhD REVIEW ARTICLE Platelet-Rich Plasma Modulates Actions on Articular Cartilage Lubrication and Regeneration TISSUE ENGINEERING: Part B Volume 22, Number 5, 2016
Aim of study
Primary Objective: To compare the efficacy of Intra Articular(IA)
autologous platelet rich plasma (PRP) and steroids in a subset of
patients with early OA of the knee
Secondary Objective: Assess the effect of PRP on pain, joint
stiffness, and physical function and to compare it with steroids
Materials & Method Study design
Open label Prospective Simple randomized Comparative interventional study with a follow up till 24 weeks
All patients gave their informed consent and the study was approved by the Institutional Ethical and Scientific Committee
Study population:
Comprised 60 adult patients, attending the Rheumatology/ Ortho OPD at
Army Hospital (R&R), Delhi Cantt, between Sep 2015 -Mar 2016
Symptomatic OA knee for at least 6 months with a prespecified pain of ≥ 40 mm on a 100 mm visual analogue scale (VAS) despite standard of care
Inclusion Criteria
Fulfilled the ACR clinical/radiographic criteria for OA knee
Symptomatic for atleast 6 months with a prespecified pain of ≥40 mm on a 100 mm visual analogue scale (VAS)
Contraindications to regular NSAIDS or weak opioids.
Patients gave informed consent
Exclusion criteria:
Received either oral, injectable (IM/ IV) or IA steroid during 3 months prior to the study.
Received an IA Hyaluronic Acid injection within the past 1 year prior to the study.
Platelet counts < 1.5 lakhs/cumm
Uni-compartment knee OA/ Grade 4 OA /Concomitant symptomatic hip OA / secondary OA
Prosthetic joint or having had arthroscopy surgery
Inclusion and Exclusion Criteria
Sample size was calculated using PS software 3.1.2, 2014
Sample size was calculated out to be 23. With loss to follow up taking up to
20%, it was rounded off to 30
Sample size & sample technique:
PRP Preparation
Sampling and the centrifugation of the PRP preparation were performed
according to criteria established by the Authority Operational Office of
Armed Forces Transfusion Centre (AFTC), Delhi
Preparation of platelet Rich Plsma
Interventional Procedure:
Patient is placed in supine position with knee in full extension
Under aseptic conditions, 6 mL of either platelet concentrate or 2 ml of Depomedrol is injected through a supralateral approach with an 18- gauge needle under ultrasound guidance
In the PRP group, 0.5 mL of CaCl2 (M/40) is injected for every 6 mL of PRP to activate platelets
The knees immobilized for 10 minutes after injection. The patients were discharged after 30 minutes of observation
Statistical analysis-
Data was analyzed using SPSS version 19
Comparison of demographic variables were done with Chi square test
t- test was carried out to compare mean difference in VAS and WOMAC score at
baseline, 6 weeks, 12 weeks and at 24 weeks
A p value <0.05 was taken as statistically significant
EnrollmentAssessed for eligibility (n=70)
Randomized (n=60)
Excluded (n=10) ♦ Not meeting inclusion criteria (n=5) ♦ Declined to participate (n=2) ♦ Other reasons (n=3)
Allocated to receive PRP infiltration (n=30) ♦ Received allocated intervention (n=30) ♦ Did not receive allocated intervention (n=0)l
Lost to follow-up (n=0)Discontinued intervention (n=0)
Analyzed (n=30)Excluded from analysis (n=0)
Allocated to receive Depomed infiltration (n=30) ♦ Received allocated intervention (n=30) ♦ Did not receive allocated intervention (n=0)
Lost to follow-up (n=0) Discontinued intervention (n=0)
Analyzed (n=30)Excluded from analysis (n=0)
Follow-up
Allocation
Analysis
Flow diagram of the study
PRP (n=30)Mean (SD)
Steroid (n=30)
Mean SDp-value
Age 53.3 ± 7.9 57.0 ± 7.2 0.08
Male 9 11 0.584
Duration of OA in years 7.3 ± 4.0 8.0 ± 4.4 0.505
BMI in Kg/m2 26.0 ± 2.3 25.8 ± 2.4 0.748
Received previous IA Steroids/ HA n= 6 8 0.526
Bony swelling n= 16 11 0.518
Knee effusion n= 4 15 0.002
Demographic and baseline clinical characteristics of study patients (n=60)
PRP group(n= 30)
Steroid(n=30)
P value
Grade 1 0 0
0.677
Grade 2 5 6
Grade 3 25 24
Grade 4 0 0
Kellgren-Lawrence score
Baseline VAS Pain scores and WOMAC scores in study patients (N=60)
PRP (n=30)Mean ±SD)(Baseline)
Steroid (n=30)Mean ± SD(Baseline)
p-value
VAS score 78.4 ± 9.2 77.2± 8.8 0.598
Total WOMAC score 75.6± 9.1 76.6± 7.6 0.524
Pain 16.0± 2.03 16.3± 1.44 0.512
Physical function 53.8± 6.6 54.3± 6.2 0.73
Stiffness 5.8± 1.3 6.3± 0.8 0.1
Results(Contd)
• At final follow-up, mean total WOMAC scores showing significant improvement
from baseline in PRP group (75.6 ± 9.1 - 34.9 ± 17.9) and VAS score ( 78.4 ± 9.2 –
45.5 ± 14.6) ; p <0.001
• In steroid group WOMAC score 76.6 ± 7.6 – 69.1 ± 9.1 and VAS score 77.2 ± 8.8 –
64.3 ± 6.3 in PRP vs Steroid groups respectively; P <0.001)
Baseline 6 Weeks 12 Weeks 24 Weeks0
10
20
30
40
50
60
70
80
90
Changes in WOMAC score from base-line to 24 weeks n(60)
IA PRPIA Steroid
Duration
WO
MAC
Sco
re 48.754.3
34.9
69.1
0.0451
43.5
61.0
Mean Western Ontario and McMaster (WOMAC) /VAS scores for the autologous platelet rich plasma (PRP) and Depomedrol (Steroid) groups.
P <0.0001P < 0.0001
45.547.5
Baseline 6 Weeks 12 Weeks 24 Weeks0
10
20
30
40
50
60
70
80
90
Change in VAS from baseline to 24 weeks N(60)
IA PRPIA Steroid
DurationVA
S Sc
ore 44.7
54.0(p < 0.0004)
64.355.4
Discussion
Summary of studies using PRP for knee osteoarthritis
PRP (n=30)mean ± SD
Steroid (n=30)Mean ± SD
p-value
WOMAC scores
Pain 10.0 ± 3.4 2.2 ± 1.3 <0.0001
Physical function 27.6 ± 11.0 4.8 ± 4.6 <0.0001
stiffness 3.1 ± 1.3 0.7± 0.6 <0.0001
WOMAC total 40.7 ± 14.7 7.5 ± 5.5 <0.0001
VAS Score 32.9 ± 12.1 12.9 ± 5.9 <0.0001
Mean difference in VAS Pain scores at baseline and 24 weeks (N=60) follow up
Conclusion
Treatment with PRP showed significantly better clinical outcomes, with
sustained improvement lasting upto 24 weeks.
PRP is a safe and cost effective mode of therapy for improvement in functional
status in early knee osteoarthritis and a minimum of two injections are
appropriate
Further studies will be required with larger sample size and longer follow up
Thank You…..