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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926327
• Other study ID #: royan-Bone-011
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2013
• Last updated: April 24, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: September 2012
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• PRP injection
Injection of PRP in patients with knee osteoarthritis.
• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection	3 months	Yes
Primary	physical activity	physical activity of patients which is measured by WOMAC scoring , before injection of PRP& 3,6 and 12 months after last injection.	3months	Yes
Primary	cartilage repair	The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.	12months	Yes
Secondary	quality of life	Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.	3months	Yes
Secondary	joint replacement	Evaluation the need for joint replacement 12months after injection.	12months	Yes

External Links

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