Knee Osteoarthritis: Platelet Rich Plasma or Hyaluronic Acid

Summary

PURPOSE: To compare the effect of hyaluronic acid (HA) or platelet-rich plasma (PRP) on pain, physical function, quality of life and knee joint morphology in patients with knee osteoarthritis severity II-III.

BACKGROUND: Knee osteoarthritis affects quality of life significantly because it is the most common joint disease and causes considerable disability. Pathogenesis is multifactorial, nevertheless reduced cartilage production, increased destruction, and synovial inflammation are important factors in the osteoarthritis process. Today, symptomatic drugs are commonly used in the treatment of osteoarthritis, but these treatments have limited effects on cartilage degeneration. Intraarticularly, hyaluronic acid (HA) and platelet-rich plasma (PRP) treatments have been used for osteoarthritis due to pain and functional effects. HA has been shown to reduce the levels of collagen degradation products and maintain normal cartilage metabolism. PRP is thought to have positive effects on clinical and tissue healing due to the numerous growth factors involved. However there is no research to prove definitively that one of the two applications in knee osteoarthritis is superior to the other.

METHOD: 120 patients between the ages of 50-70, OA severity II-III will be included in the study. Patients will be stratified according to the severity and age of OA, and two groups will be randomly assigned as HA and PRP. HA and PRP injections will be performed two times and one month apart. Outcome measures are pain, physical function, quality of life, muscle strength, WORMS, and patient satisfaction. Each patient will be examined at baseline, first, third, sixth, ninth and twelfth months.

Conditions

• Knee Osteoarthritis

Interventions

DEVICE

Platelet Rich Plasma Treatment Group (PRP)

EASY PRP is in category IIa and manufactured by Neotec Biotechnology Industry and Foreign Trade Company. (Item No. 8680976403603; UNSPSC 42295470; GMDN 46923; certificate no: M.2016.106.7294).

DEVICE

Hyaluronic Acid Treatment Group (HA)

REGENFLEX STARTER is a class III intraarticular viscosupplementation device (Art. No. 8681065100076; UNSPSC 42295509). Sodium hyaluronate is obtained by bacterial fermentation (STREPTOCOCCUS EQUI) method. The product is in disposable packages, sterile and contained in a 2 ml pyrogen-free syringe.

Sponsors & Collaborators

• The Scientific and Technological Research Council of Turkey

  collaborator OTHER

• Antalya Training and Research Hospital

  lead OTHER_GOV

Principal Investigators

• NFusun Toraman, Prof · Ministry of Health Antalya Training and Research Hospital

• Meral Bilgilisoy Filiz, MD,PM&R · Ministry of Health Antalya Training and Research Hospital

• Yasemin Karaman, MD,Radiology · Ministry of Health Antalya Training and Research Hospital

• Sevim Yildiz, MD,Radiology · Ministry of Health Sancaktepe Training and Research Hospital

• Asli Karadag Ozdemir, MD,Res.Ass. · Health Sciences University Antalya Training and Research Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-07

Primary Completion

2020-01-07

Completion

2020-03-07

Countries

• Turkey (Türkiye)

Study Locations