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Randomized, Double-blind, 12-month, placebo-controlled study was conducted on 100 outpatients . Intervention platelet rich plasma( PRP) prepared from 60 ml of blood by adding novel step of filtration to manual centrifuge step to achieve 7 times concentration. the efficacy was compared with administration of hyaluronic acid. Subjective Womac scores ,6 min pain free walking distance as well objective assessments MRI ,synovial fluid assessments were made out .Absolute counts of platelets as dose was evaluated to be effective in alleviating symptoms in early knee OA.
Osteoarthritis (OA) causes substantial physical disability that limits a person ability to indulge in daily activities. OA related disability has been affecting millions of older adults throughout the world, and the number has almost doubled in 2019.
Though the process of OA could not be reversed, efficient management strategies could help in minimizing primary pain with physical exercises, surgical procedures, and medications.
Prolonged use of nonsteroidal anti-inflammatory drugs (NSAIDs) has been dramatically associated with mild to severe side effects, limiting its continuous use. Chondro-protective agents (CPAs) have been proven to provide only minimal symptomatic benefit. Platelet-rich plasma (PRP) has emerged as a supreme therapy in OA knee however exact dose ,preparation and duration of benefit still remains unclear.
Study was undertaken to demonstrate the potential of leukocyte depleted PRP in cartilage repair of knee OA using WOMAC scores as subjective assessment tool.
Our research also evaluated objective criteria ing joint space width (JSW),cartilage thickness on MRI, Ultrasound that would improve knee joint function in patients with knee OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP (100billion platelets) | Experimental | platelet rich plasma having 100 billion platelets in 10 ml plasma prepared from 60 ml blood |
|
| hyaluronic acid | Placebo Comparator | Four ml of high-molecular-weight hyaluronic acid (HMWHA) with a concentration of 22mg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma | Biological | Platelet rich plasma : 100 billion platelets in 10 ml of plasma(PRP) administered intra-articular |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in womac score | WOMAC, a widely used measure to assess patients' pain, joint mobility, and physical disability evaluates three dimensions, pain, stiffness, and physical function, with 5, 2, and 17 questions, respectively. The total maximum score is 96 and minimum, 0 | baseline,1 month,3 months,6 months, and 1year |
| changes in cartilage thickness as assessed on 1.5 T MRI | Using the 1.5-T field strength with standard MRI acquisition protocols, MRI was performed of each joint individually in coronal, sagittal, and transverse planes. The maximum thickness of the cartilage at posterior,meniscal and patellar level measured at the midsagittal plane through the medial condyle was considered. The medial femoral cartilage of the affected knee was chosen for measurement. | baseline and at one year |
| Measure | Description | Time Frame |
|---|---|---|
| changes in joint space width | Patients were radiographed in a weight-bearing position, joints fully extended, standing at 1 m from the X-ray source20. The width was measured at the narrowest point of the Joint (JSW) | baseline and at 12months |
| changes in cartilage thickness as assessed by ultrasonically. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| himanshu bansal, ms | anupam hospital rudrapur uttrakhand | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25925602 | Result | Riboh JC, Saltzman BM, Yanke AB, Fortier L, Cole BJ. Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. Am J Sports Med. 2016 Mar;44(3):792-800. doi: 10.1177/0363546515580787. Epub 2015 Apr 29. | |
| 26861957 | Result | Paterson KL, Nicholls M, Bennell KL, Bates D. Intra-articular injection of photo-activated platelet-rich plasma in patients with knee osteoarthritis: a double-blind, randomized controlled pilot study. BMC Musculoskelet Disord. 2016 Feb 9;17:67. doi: 10.1186/s12891-016-0920-3. |
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Anyone interested, Researcher ,Patient or Institute can contact and we would gladly assist him with all information. Nothing is hidden
Data will be always available to anyone interested
Anyone interested, Researcher ,Patient or Institute can access data anytime.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| C049816 | hylan |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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182 patients screened, 100 were considered eligible for the study and were randomized. The most common reason for exclusion was either the lack of radio graphic evidence of knee OA or the presence of severe disease with JSW less than 2 mm at the narrowest point.
Out of the 100 randomized patients, roughly equal numbers, six patients in PRP and 7 in placebo, did not complete the study. Reasons for withdrawal were personal,inefficacy, or adverse event as an increase in pain.
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Hyaluronic acid as placebo both patient and investigator blinded
| Hyaluronic Acid | Drug | Hyaluronic acid :Four ml of high-molecular-weight hyaluronic acid with a concentration of 22mg/ml injected intra-articular |
|
|
Having the patients sit with flexed knees,The articular cartilage of the medial femoral condyle was evaluated with a starting point at the level of intercondylar notch to the medial border of the medial condyle by an ultrasound. |
| baseline ,6 months and at 12 months |
| 28146403 | Result | Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21. |
| D012216 |
| Rheumatic Diseases |