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Completed

NCT Number: NCT02211521

Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid 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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP

Biological

3ml of PRP

Other names: GPS III, Biomet Biologics, Warsaw, Ind, USA

Hyaluronic acid

Drug

3ml hyaluronic acid

Other names: LBSA0103, 60 mg/3ml, LG Life Sciences, Korea

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Number of Participants with Adverse Events

    Time frame: Week 6, Week 12, Week 24

    All adverse events included

  4. 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

  5. Patient global assessment

    Time frame: Week 6, Week 12, Week 24

    Patient global assessment was evaluated for improvement of symptoms using 100mm VAS.

  6. 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

Other outcomes

  1. 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

  2. Level of platelet of platelet rich plasma

    Time frame: baseline

    Assessment of level of platelet of platelet rich plasma

  3. 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)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2014
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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