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

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ClinicalTrials.gov Identifier: NCT01926327
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : April 25, 2014
Information provided by (Responsible Party):
Royan Institute

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: PRP injection Biological: Placebo Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Intraarticular Injection of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee (in a Clinical Trial Phase III)
Study Start Date : January 2013
Primary Completion Date : March 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: platelet reach plasma
The patients with osteoarthritis who underwent PRP injection.
Biological: PRP injection
Injection of PRP in patients with knee osteoarthritis.
Placebo Comparator: placebo
The patients with osteoarthritis who underwent Normal Saline injection.
Biological: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT01926327

Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of Department of Regenerative Medicine Of Royan Institute & cell therapy center
Study Director: Mohsen Emadedin, MD Orthoped scientist in Royan Institute
Principal Investigator: Ali Mirazimi Bafghi, MD Regenerative Medicine Department of Royan Institute

Additional Information:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01926327     History of Changes
Other Study ID Numbers: royan-Bone-011
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: September 2012

Keywords provided by Royan Institute:
PRP PRGF Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases