MedDataX Logo

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

NCT ID: NCT02211521

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Osteoarthritis, platelet-rich plasma, hyaluronic acid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PRP group

Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of autologous Platelet-Rich Plasma (3ml).

Group Type EXPERIMENTAL

PRP

Intervention Type BIOLOGICAL

3ml of PRP

Hyaloronan group

Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of hyaluronic acid (3ml)

Group Type ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type DRUG

3ml hyaluronic acid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PRP

3ml of PRP

Intervention Type BIOLOGICAL

Hyaluronic acid

3ml hyaluronic acid

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GPS III, Biomet Biologics, Warsaw, Ind, USA LBSA0103, 60 mg/3ml, LG Life Sciences, Korea

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ChulWon Ha

Professor of Department of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chul-WOn Ha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23104611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22513879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21831567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24192391 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33523756 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-12-056

Identifier Type: -

Identifier Source: org_study_id