The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee
|ClinicalTrials.gov Identifier: NCT01926327|
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : April 25, 2014
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:
- Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal anti-inflammatory drugs.
- Intra-articular injections of corticosteroids and hyaluronic acid.
- 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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||April 2014|
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.
- pain [ Time Frame: 3 months ]pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection
- 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.
- cartilage repair [ Time Frame: 12months ]The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.
- quality of life [ Time Frame: 3months ]Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.
- joint replacement [ Time Frame: 12months ]Evaluation the need for joint replacement 12months after injection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926327
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|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|