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

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ClinicalTrials.gov Identifier: NCT02211521
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
ChulWon Ha, Samsung Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: PRP Drug: Hyaluronic acid Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211521


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Chul-WOn Ha, MD, PhD Samsung Medical Center, Sungkyunkwan University School of Medicine

Publications:
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Responsible Party: ChulWon Ha, Professor of Department of Orthopaedic Surgery, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02211521     History of Changes
Other Study ID Numbers: 2013-12-056
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015

Keywords provided by ChulWon Ha, Samsung Medical Center:
Osteoarthritis, platelet-rich plasma, hyaluronic acid

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents