Clinical trial NCT01926327: The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: PRP PRGF Osteoarthritis
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2013-08-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain
timeFrame: 3 months
measure: physical activity
timeFrame: 3months
measure: cartilage repair
timeFrame: 12months
Secondary outcomes:
measure: quality of life
timeFrame: 3months
measure: joint replacement
timeFrame: 12months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Department of Regenerative Medicine Of Royan Institute & cell therapy center
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Orthoped scientist in Royan Institute
name: Mohsen Emadedin, MD
role: STUDY_DIRECTOR
affiliation: Regenerative Medicine Department of Royan Institute
name: Ali Mirazimi Bafghi, MD
role: PRINCIPAL_INVESTIGATOR
References: