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Osteoarthritis, KneePhase 3NCT02211521

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

A Phase 3 study testing PRP and Hyaluronic acid in people with Osteoarthritis, Knee, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
PRP and Hyaluronic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteSouth Korea
Study dates
Aug 2014to Oct 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
PRP, Hyaluronic acid
Keywords
Osteoarthritis, platelet-rich plasma, hyaluronic acid
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRPBiological

    Also called GPS III, Biomet Biologics, Warsaw, Ind, USA

    3ml of PRP

  • Hyaluronic acidDrug

    Also called LBSA0103, 60 mg/3ml, LG Life Sciences, Korea

    3ml hyaluronic acid

Study groups in NCT02211521
Study groupRoleWhat they receive
PRP groupExperimentalPatients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of autologous Platelet-Rich Plasma (3ml).
Receives: Biological: PRP
Hyaloronan groupActive comparatorPatients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of hyaluronic acid (3ml)
Receives: Drug: Hyaluronic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in International Knee Documentation Committee subjective score at week 24

    International Knee Documentation Committee subjective score for both groups

    Measured: Baseline, Week 24

Secondary outcomes (6)

  1. Change from baseline in VAS (Visual Analogue scale) for pain during walking

    VAS (Visual Analogue scale) for pain during walking for both groups of treatment

    Measured: Baseline, Week 6, Week 12, Week 24

  2. Change from baseline in Western Ontario and McMaster Universities Arthritis Index

    Western Ontario and McMaster Universities Arthritis Index variation for both groups

    Subscale analysis of pain, stiffness, function also contain

    Measured: Baseline, Week 6, Week 12, Week 24

  3. Number of Participants with Adverse Events

    All adverse events included

    Measured: Week 6, Week 12, Week 24

  4. Change from baseline in Samsung Medical Center Patellofemoral score (SMC patellofemoral score)

    Samsung Medical Center Patellofemoral score for both groups of treatment

    Measured: Baseline, Week 6, Week 12, Week 24

  5. Patient global assessment

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

    Measured: Week 6, Week 12, Week 24

  6. Change from baseline in International Knee Documentation Committee subjective score at week 6, week 12

    International Knee Documentation Committee subjective score for both groups

    Measured: Baseline, Week 6, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02211521
Sponsor's protocol ID
2013-12-056
Status last verified
Dec 2015
First submitted
18 Jul 2014
Last updated
10 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25.

    PubMed 23104611

  • Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.

    PubMed 22513879

  • Kon E, Mandelbaum B, Buda R, Filardo G, Delcogliano M, Timoncini A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular injection versus hyaluronic acid viscosupplementation as treatments for cartilage pathology: from early degeneration to osteoarthritis. Arthroscopy. 2011 Nov;27(11):1490-501. doi: 10.1016/j.arthro.2011.05.011. Epub 2011 Aug 10.

    PubMed 21831567

  • Sundman EA, Cole BJ, Karas V, Della Valle C, Tetreault MW, Mohammed HO, Fortier LA. The anti-inflammatory and matrix restorative mechanisms of platelet-rich plasma in osteoarthritis. Am J Sports Med. 2014 Jan;42(1):35-41. doi: 10.1177/0363546513507766. Epub 2013 Nov 5.

    PubMed 24192391

  • Park YB, Kim JH, Ha CW, Lee DH. Clinical Efficacy of Platelet-Rich Plasma Injection and Its Association With Growth Factors in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial As Compared With Hyaluronic Acid. Am J Sports Med. 2021 Feb;49(2):487-496. doi: 10.1177/0363546520986867.

    PubMed 33523756

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PRP and Hyaluronic acid in people with Osteoarthritis, Knee, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in International Knee Documentation Committee subjective score at week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02211521, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.

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