- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01926327
The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee
The Effects of Intraarticular Injection of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee (in a Clinical Trial Phase III)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Royan Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: platelet reach plasma
The patients with osteoarthritis who underwent PRP injection.
|
Injection of PRP in patients with knee osteoarthritis.
|
Placebo Comparator: placebo
The patients with osteoarthritis who underwent Normal Saline injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain
Time Frame: 3 months
|
pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection
|
3 months
|
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.
|
3months
|
cartilage repair
Time Frame: 12months
|
The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.
|
12months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life
Time Frame: 3months
|
Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.
|
3months
|
joint replacement
Time Frame: 12months
|
Evaluation the need for joint replacement 12months after injection.
|
12months
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- royan-Bone-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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