Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid for the Treatment of Osteoarthritis of the Knee Joint

December 9, 2015 updated by: ChulWon Ha, Samsung Medical Center

Randomized, Double Blind, Comparison Clinical Trial to Test the Efficacy and Safety of Intraarticular Injection of Autologous Platelet-rich Plasma (PRP) for the Treatment of Osteoarthritis of the Knee Joint

The purpose of this study is to compare the efficacy of platelet-rich plasma versus hyaluronic acid intra-articular injections for the treatment of osteoarthritis of knee joint.

The hypothesis is that PRP intra-articular injection is comparable or even better than hyaluronic acid injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis (OA) has a significant impact on our society. The limited regenerative capacity of cartilage is part of this problem. Existing degenerative lesions lead to accelerated deterioration of the articular (joint) surface leading to end-stage arthritis. In particular, the most recent knowledge regarding tissue biology highlights a complex regulation of growth factors (GFs) for the normal tissue structure and the reaction to tissue damage. The influence of GFs on cartilage repair is now widely investigated in vitro and in vivo. Platelet Rich Plasma (PRP) is a simple, low- cost and minimally- invasive method that allows one to obtain a natural concentrate of autologous GFs from the blood, and it is increasingly applied in the clinical practice to treat knee degenerative pathology, such as chondropathy and early OA. The biological rational of PRP is that platelets contain storage pools of GFs, cytokines, chemokines and many other mediators.Although its widespread application, there are little high level studies in the literature to demonstrate the real efficacy of PRP.

The investigators hypothesized that intra-articular injections of PRP to treat knee osteoarthritis could determine pain relief and recovery of knee function with overall clinical outcome comparable or even better than viscosupplementation, which is a common injective approach applied in this kind of pathology. To this purpose the investigators designed a double blind randomized controlled trial comparing PRP vs viscosupplementation.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with osteoarthritis of knee (by American College of Rheumatology Criteria) and Kellgren-Lawrence grade I ~ III
  • More than 40 out of 100-mm VAS scale for pain at screening and baseline
  • Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

  • Patients with Hb values < 10 g/dl and platelet values < 100,000/ul
  • Patients with a current or medical history of autoimmune disease
  • Recent fever ( within 2 weeks) or serious illness
  • Local infection at the site of the procedure
  • Corticosteroid injection at treatment site within 1 month
  • Systematic use of corticosteroids within 2 weeks
  • Female participants who are pregnant, lactating or planning pregnancy during the course of the study
  • Patients who have been administered with immunosuppressants within the past 6 weeks
  • Patients who are enrolled in any other clinical trials within 4 weeks
  • Patients who the principal investigator considers inappropriate for participation in the clinical trial for reasons other than those listed above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP group
Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of autologous Platelet-Rich Plasma (3ml).
Biological: PRP
3ml of PRP
Other Names:
  • GPS III, Biomet Biologics, Warsaw, Ind, USA
Active Comparator: Hyaloronan group
Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of hyaluronic acid (3ml)
Drug: Hyaluronic acid
3ml hyaluronic acid
Other Names:
  • LBSA0103, 60 mg/3ml, LG Life Sciences, Korea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in International Knee Documentation Committee subjective score at week 24
Time Frame: Baseline, Week 24
International Knee Documentation Committee subjective score for both groups
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in VAS (Visual Analogue scale) for pain during walking
Time Frame: Baseline, Week 6, Week 12, Week 24
VAS (Visual Analogue scale) for pain during walking for both groups of treatment
Baseline, Week 6, Week 12, Week 24
Change from baseline in Western Ontario and McMaster Universities Arthritis Index
Time Frame: Baseline, Week 6, Week 12, Week 24

Western Ontario and McMaster Universities Arthritis Index variation for both groups

Subscale analysis of pain, stiffness, function also contain
Baseline, Week 6, Week 12, Week 24
Number of Participants with Adverse Events
Time Frame: Week 6, Week 12, Week 24
All adverse events included
Week 6, Week 12, Week 24
Change from baseline in Samsung Medical Center Patellofemoral score (SMC patellofemoral score)
Time Frame: Baseline, Week 6, Week 12, Week 24
Samsung Medical Center Patellofemoral score for both groups of treatment
Baseline, Week 6, Week 12, Week 24
Patient global assessment
Time Frame: Week 6, Week 12, Week 24
Patient global assessment was evaluated for improvement of symptoms using 100mm VAS.
Week 6, Week 12, Week 24
Change from baseline in International Knee Documentation Committee subjective score at week 6, week 12
Time Frame: Baseline, Week 6, Week 12
International Knee Documentation Committee subjective score for both groups
Baseline, Week 6, Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of white blood cell count of platelet rich plasma
Time Frame: baseline
Assessment of level of WBC, platelet and several growth factors of platelet rich plasma Assessment of level of white blood cell count of platelet rich plasma
baseline
Level of platelet of platelet rich plasma
Time Frame: baseline
Assessment of level of platelet of platelet rich plasma
baseline
Level of growth factors of platelet rich plasma
Time Frame: baseline
Assessment of level several growth factors of platelet rich plasma (platelet derived growth factor, transforming growth factor -b1, vascular endothelial growth factor, epidermal growth factor, fibroblast growth factor etc)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Chul-WOn Ha, MD, PhD, Samsung Medical Center, Sungkyunkwan University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-12-056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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