To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Platelet rich plasma
Hyaluronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Platelet rich plasma
Eligibility Criteria
Inclusion Criteria:
- Outpatients who fulfilled the clinical and radiological criteria set by the American College of Rheumatology for the diagnosis of symptomatic primary knee OA, with pain Visual Analogue Scale (VAS) score of >3 in the previous month. In cases where both the knees were symptomatic, the knee which was comparatively more painful was considered.
Exclusion Criteria:
- Evidence of secondary knee OA because of injury, inflammatory or metabolic rheumatic disease, or osteonecrosis;
- Prior intra-articular injection of hyaluronic acid (HA), including lavage and corticosteroids within the previous three months;
- Severe knee OA, with JSW <1 mm, or surgery required on the evaluated knee in the year
- Patients with clinically significant systemic disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PRP (100billion platelets)
hyaluronic acid
Arm Description
platelet rich plasma having 100 billion platelets in 10 ml plasma prepared from 60 ml blood
Four ml of high-molecular-weight hyaluronic acid (HMWHA) with a concentration of 22mg/ml
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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)
changes in cartilage thickness as assessed by ultrasonically.
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.
Full Information
NCT ID
NCT04198467
First Posted
December 9, 2019
Last Updated
December 12, 2019
Sponsor
Dr. Himanshu Bansal Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04198467
Brief Title
To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid
Official Title
Randomized Controlled Study to Compare Safety and Efficacy of Intra Articular Administration of Platelet Rich Plasma Versus Hyaluronic Acid as Placebo in Patients With Osteoarthritis of Knee
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 21, 2014 (Actual)
Primary Completion Date
April 15, 2016 (Actual)
Study Completion Date
July 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Himanshu Bansal Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Platelet rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
Hyaluronic acid as placebo both patient and investigator blinded
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP (100billion platelets)
Arm Type
Experimental
Arm Description
platelet rich plasma having 100 billion platelets in 10 ml plasma prepared from 60 ml blood
Arm Title
hyaluronic acid
Arm Type
Placebo Comparator
Arm Description
Four ml of high-molecular-weight hyaluronic acid (HMWHA) with a concentration of 22mg/ml
Intervention Type
Biological
Intervention Name(s)
Platelet rich plasma
Other Intervention Name(s)
PRP
Intervention Description
Platelet rich plasma : 100 billion platelets in 10 ml of plasma(PRP) administered intra-articular
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
SYNVISC
Intervention Description
Hyaluronic acid :Four ml of high-molecular-weight hyaluronic acid with a concentration of 22mg/ml injected intra-articular
Primary Outcome Measure Information:
Title
changes in womac score
Description
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
Time Frame
baseline,1 month,3 months,6 months, and 1year
Title
changes in cartilage thickness as assessed on 1.5 T MRI
Description
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.
Time Frame
baseline and at one year
Secondary Outcome Measure Information:
Title
changes in joint space width
Description
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)
Time Frame
baseline and at 12months
Title
changes in cartilage thickness as assessed by ultrasonically.
Description
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.
Time Frame
baseline ,6 months and at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients who fulfilled the clinical and radiological criteria set by the American College of Rheumatology for the diagnosis of symptomatic primary knee OA, with pain Visual Analogue Scale (VAS) score of >3 in the previous month. In cases where both the knees were symptomatic, the knee which was comparatively more painful was considered.
Exclusion Criteria:
Evidence of secondary knee OA because of injury, inflammatory or metabolic rheumatic disease, or osteonecrosis;
Prior intra-articular injection of hyaluronic acid (HA), including lavage and corticosteroids within the previous three months;
Severe knee OA, with JSW <1 mm, or surgery required on the evaluated knee in the year
Patients with clinically significant systemic disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
himanshu bansal, ms
Organizational Affiliation
anupam hospital rudrapur uttrakhand
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anyone interested, Researcher ,Patient or Institute can contact and we would gladly assist him with all information. Nothing is hidden
IPD Sharing Time Frame
Data will be always available to anyone interested
IPD Sharing Access Criteria
Anyone interested, Researcher ,Patient or Institute can access data anytime.
IPD Sharing URL
http://www.drhbf.org
Citations:
PubMed Identifier
25925602
Citation
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.
Results Reference
result
PubMed Identifier
26861957
Citation
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.
Results Reference
result
PubMed Identifier
28146403
Citation
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. Erratum In: Am J Sports Med. 2017 Apr;45(5):NP10.
Results Reference
result
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To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid
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