Skip to main content
OpenTrials
Completed

NCT Number: NCT01926327

The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee

Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the knee has significantly elevated in the elderly population and youth due to age and sport activities respectively. Our aims to treat the knee osteoarthritis are including; reduce knee pain and improve its function; return patients to normal daily activities and reduce health care costs.

The current treatments which are already being used for osteoarthritis of the knee patients include:

1. Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal anti-inflammatory drugs. 2. Intra-articular injections of corticosteroids and hyaluronic acid. 3. Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.

As the low mitotic activity and lack of blood supply cause little ability for the articular cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received much more attention due to its capacity to do self-healing in treatment of osteoarthritis of the knee.

PRP consists of several concentrated growth factors in platelets of autologous blood that are applied to the different parts of medicine such as reconstruction of damaged tissue. Although platelets are well-known to involve in the blood clots formation, but current studies have shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells and osteoblasts to remove necrotic tissue in addition to participate in healing procedure.

This study is a prospective, randomized, controlled trial to assess The positive effects of platelet-rich plasma injection in 244 patients with osteoarthritis of the knee

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royan Institute

Tehran, Iran

About this study

In this study all eligible patients (Based on the inclusion and exclusion criteria) were randomly allocated into two study groups by a Stratified Permuted Block randomization method: group A received platelet rich plasma, group B (control group) received only placebo.

All of the patients underwent a standard long protocol for knee osteoarthritis. All patients with grade II,III and IV of radiographic knee OA are selected. On average, in each instance, the amount of platelets in the peripheral blood is 4 to 6 times the baseline level.

Group A: 1-3 cc injection of placebo Group B: 1-3 cc injection of PRP All patients received monthly injection for 3 times.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 to 65 years
  • Body mass index (BMI) ≤33 kg/m2
  • Grade 2And above imaging of osteoarthritis
  • History of knee pain or swelling should have at least 4 months

Exclusion criteria

  • treated with steroids and Anti-coagulant or anti-platelet aggregation
  • history of infectious, systemic diseases, Immune deficiency and coagulation disorders
  • Patients with Hb ≤11, Plt ≤ 150000
  • Varus > 10 , valgus > 10

Treatment and study plan

PRP injection

Biological

Injection of PRP in patients with knee osteoarthritis.

Placebo

Biological

Primary outcomes

  1. pain

    Time frame: 3 months

    pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection

  2. physical activity

    Time frame: 3months

    physical activity of patients which is measured by WOMAC scoring , before injection of PRP& 3,6 and 12 months after last injection.

  3. cartilage repair

    Time frame: 12months

    The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.

Secondary outcomes

  1. quality of life

    Time frame: 3months

    Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.

  2. joint replacement

    Time frame: 12months

    Evaluation the need for joint replacement 12months after injection.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

The Effects of Intraarticular Injection of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee (in a Clinical Trial Phase III)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2013
Registry last updated
Apr 25, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.