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

NCT01926327 | Completed Phase 3 DMC

• 1 other identifier: royan-Bone-011
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal anti-inflammatory drugs.
2. 2.Intra-articular injections of corticosteroids and hyaluronic acid.
3. 3.Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.

Conditions

Osteoarthritis

Keywords

PRP PRGF Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• pain

  pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection

  3 months

• 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

• cartilage repair

  The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.

  12months

Secondary Outcomes (2)

• quality of life

  3months

• joint replacement

  12months

Study Arms (2)

platelet reach plasma

ACTIVE COMPARATOR

The patients with osteoarthritis who underwent PRP injection.

Biological: PRP injection

placebo

PLACEBO COMPARATOR

The patients with osteoarthritis who underwent Normal Saline injection.

Biological: Placebo

Interventions

PRP injection BIOLOGICAL

Injection of PRP in patients with knee osteoarthritis.

platelet reach plasma

Placebo BIOLOGICAL

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Ali Mirazimi Bafghi, MD

  Regenerative Medicine Department of Royan Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2013
• First Posted: August 20, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 25, 2014

Record last verified: 2012-09

Locations

IR (1)