Prof. FABIO CERZA A.Carcangiu, S.Carnì, A. Pecora, I. Di Vavo, V. Schiavilla

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1 Department of Orthopaedics and Traumatology P.Colombo Hospital Velletri(ROME) Prof. FABIO CERZA A.Carcangiu, S.Carnì, A. Pecora, I. Di Vavo, V. Schiavilla

2 4 million Italians suffer from arthrosis Most cases of arthrosisare located in the knee which can be quite debilitating In many cases drugs not give any benefit And surgery is not indicated Many of this cases are treated by intra-articular injection

3 Primary component of synovial fluid 1) lubrication of the articular surface 2) reduction of surface stress extending the load zone 3) transportation of chondro-nutritive substances from the synovia. Literature has described the synovial fluid within an arthritic joint to have a noticeably diminished HA concentration

4 1) Viscosupplementation: restores the mechanical and viscoelasticproperties of the synovial fluid WORKS in two ways 2) Viscoinduction: stimulates the endogenous production of HA by synoviocytes and chondrocytes

5 A new type treatment: is the result of autologous whole blood centrifugation to obtain plasma with an increased platelet concentration Platelets contain growth factors (such as IGF-1, bfgf, PDGF, EGF, VEGF, and TGf β) within their alpha granules

6 The use of growth factors has become increasingly popular to modulate the healing time of injured and damaged tissues PRPhas been used in maxillofacial and plastic surgery for over a decade

7 Platelets contain growth factors which are involved in the process of inflammation reduction, necrotic cell removal, and tissue repair In orthopaedic practice was used for arthritis, synovitis, tendinous inflammation, and lesions of the meniscus and articular cartilage

8 Very few studies analyzing the clinical results of infiltrative application of PRP in OA of the knee. In our best knowledge any study compare HA and PRP in OA of the knee Knee Surg Sports Traumatol Arthrosc Platelet-rich plasma: intra-articularknee injections produced favorable results on degenerative cartilage lesions. KonE, Etal Clin Exp Rheumatol Sep-Oct;26(5): Intra-articular injection of an autologous preparation rich in growth factors for the treatment of knee OA: a retrospective cohort study. Sanchez M, etal.

9 1) Avaluationofclinicalresultsin intra-articularinjectionwith platelet-richplasma in gonarthrosis 2) ComparisonbetweenHA and PRP

10 A protocol of treatment was approved by the Health Department The study was authorized by the local ethical committee All Patients gave their informed consent

11 ACP The specific PRP used in this study was AutologousConditioned Plasma (Arthrex). 1. high amount of growth factors 2. significantly decreased amount of white blood cells (WBCs) Sampson S, Gerhardt M, MandelbaumB. Platelet rich plasma injection grafts for musculoskeletal injuries: a review Curr Rev Musculoskelet Med 2008;1:

12 In HA preparation the fermentation method has proved to be safe as it is not of animal origin and susceptible to viral infections. The CD44 receptor for HA on the membrane of synoviocytes seems to have a higher affinity for substances with medium to low molecular weight (between 500,000 and 4,000,000 D), due to stoichiometric reasons. Hylaganthe type of HA used in this study, is a fermentative HA with a low molecular weight (500, ,000 D)

13 The infiltration technique used for both groups was the lateral approach Intra-articularpenetration of the drug in up to 93 % of the cases (Jackson DW et.al. Accuracy of needle placement into the intra-articularspace of the knee. J BoneJoint SurgAm The patient was laid down in a supine position, the knee slightly bent with the help of a poplitealcushion. The medial, lateral and superior edges of the patella were always marked. After local anaesthesia with lidocainechlorhydrate, a lateral approach was used with the needle at an angle of about 45 toward the medial joint line of the knee into the soft spot between the patella and the femur

14 GROUP A 60 Patients Treated with PRP infiltration 25 males and 35 females with an average age of 66.5 (minimum 31, maximum 90) GROUP B 60 Patients Treated with HA infiltration 28 males and 32 females with an average age of 69.2 (minimum 36, maximum 87)

15 EXCLUSION CRITERIA NOT UNDERGONE PREVIOUS KNEE OPERATIONS AND DID NOT PRESENT ANY DOCUMENTED RHEUMATIC OR AUTOIMMUNE PATHOLOGIES INCLUSION CRITERIA PATIENTS AFFECTED BY CLINICALLY AND RADIOGRAPHICALLY DOCUMENTED GONARTHROSISIN PHASE 1, 2 OR 3 ACCORDING TO THE KELLGREN-LAWRENCE RADIOGRAPHIC CLASSIFICATION SCALE

16 120 Patients 28; 24% 46; 38% 46; 38% grade I grade II Grade III

17 ACP GROUP right knee 43 left knee 17 cases. HA GROUP right knee 48 left knee 12 cases 15; 25% 24; 40% 21; 35% grade I grade II grade III 13; 25; 22% grade I 41% grade II 22; 37% grade III No statistical differences between the two groups

18 PRP Blood withdrawal using the ArthrexACP Double Syringe System 4 intra-articularinfiltrations of ACP, performed once a week for 4 weeks The average volume of ACP injected in our series is 5.5 ml HA 4 intra-articular infiltrations of HA, performed once a week for 4 weeks The average volume of HA injected is 2 ml

19 All patients were evaluated before infiltration and at 4, 12 and 24 weeks following the first infiltration 1) Pain 2) Articular stiffnes 3) Functional limitation Western Ontario and McMaster osteoarthritis index questionnaire (WOMAC) (The minimum score of this evaluation questionnaire was equal to zero, whereas the maximum, most debilitating score was equal to 96)

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21 At the 4 weektime period, both groups showed a significant reduction in the overall WOMAC score compared to the initial score (p< 0.001) However the recorded difference between groups was statistically significant at this time point.

22 At the 12 week time period, a reversal trend was observed with a continuous improvement of the patients treated with ACP and a slight worsening in patients treated with HA At the 24 week time period, a continuous improvement in subjects treated with ACP was observed, whereas the subjects treated with HA showed a sharp worsening (p< 0.001)

23 ACP Group Pre- Post 4 Treatment weeks Post 12 weeks Post 24 weeks Average 76,9 49,6 39,1 36,5 Std Dev 9,6 17,7 17,8 17,9 Min Max HA Group Pre- Post 4 Treatment weeks Post 12 weeks Post 24 weeks Average 75,4 55,2 57,0 65,1 Std Dev 10,9 12,3 11,7 10,6 Min Max WOMAC scores for ACP Group and HA Group

24 In the ACP group there were significant differences between Pretreatment and all follow up time points (4weeksp <.001,12weeksp<.001,and24weeksp<.001). In addition, there were significant differences between 4 and 12 weeks (p<.001)and between 4 and24weeks (p<.001). There was no difference between weeks 12 and 24(p=.007).

25 In the HA group there were significant differences between Pre-treatment and all follow up time points (4weeksp<.001,12weeksp<.001,and24weeksp<.001). In addition, there were significant differences between 4 and 24 weeks (p <.001)and 12 and 24weeks (p<.001) There was no difference between 4 and 12 weeks (p=.196)

26 At 24th week: Only one patient in the ACP had no improvement of his symptomatologywith an unvaried WOMAC score in the three follow-ups two patients had an overall improvement of their symptomatologywith a reduction of the score to 5 WOMAC points. In the HA group: One patient with an unvaried WOMAC score in the three follow-ups was observed.

27 Mean WOMAC scores for Group A (ACP) and B (HA)

28 In ACP group there are no statistical differences between different grade of OA in relation to WOMAC score improvement In the HA group at 12 and 24 weeks a worse result was observed in grade III (p=0,03)

29 ACP seems to have a prolonged improvement at 12 and 24 weeks in grade III compared to HA Grade I Grade II 20 0 pre 4 w 12 w 24 w Grade III Grade I Grade III ACP GROUP

30 In grade III excellent response at 4 weeks, worst result at 12 and 24 weeks pre 4 w 12 w 24 w grade III grade I grade I grade II grade III HA GROUP

31 The conservative treatment of gonarthrosishas been well documented in the literature over the last fifty years. Treatment with HA restores the natural rheological and metabolic homeostasis of the joints affected by the arthroticprocess.

32 This new therapeutic approach with PRP can be easily performed and provides a therapy option without any severe side effects for the patient. A treated patient can then return to normal daily activities of living without any difficulties immediately after the infiltration.

33 Treatment with local infiltration of ACP has a significant effect shortly after the last infiltration and a continually improving sustained effect up to 24 weeks the clinical outcomes are better compared to the results with HA. Particularly in grade III 4 week: Ha=PRP 12 week PRP>HA 24 week PRP>HA

34 Treatment with PRP could potentially have an anti-inflammatory effect on soft tissues by releasing vital growth factors, both in acute and chronic cases. Reduction of negative effects from the reactive oxygen species, proteolytic enzymes, and matrix metalloproteinases (MMPs) released by WBCs with ACP system

35 The ArthrexACP Double Syringe System proved to be very comfortable and rapid in the treatment of gonarthrosisusing autologousblood while maintaining sterility of the end-product

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