Efficacy of intra-articular injection of a newly developed plasma rich in growth factors (PRGF) versus hyaluronic acid on pain and function of patients with knee osteoarthritis

• Register: IRCT
• Last refreshed on: 26 March 2018
• Main ID: IRCT20130523013442N23
• Date of registration: 2018-03-24
• Prospective Registration: No
• Primary sponsor: Vice chancellor for research, Shahid Beheshti University of Medical Sciences
• Public title: Efficacy of intra-articular injection of a newly developed plasma rich in growth factors (PRGF) versus hyaluronic acid on pain and function of patients with knee osteoarthritis
• Scientific title: Efficacy of intra-articular injection of a newly developed plasma rich in growth factors (PRGF) versus hyaluronic acid on pain and function of patients with knee osteoarthritis: A single-blinded randomized clinical trial
• Date of first enrolment: 2018-02-19
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/29336
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study a total of 60 patients with more than three months of chronic pain in the knee joints along with consistent imaging findings (Kellgren-Lawrence score of ?&?) would be enrolled and randomly allocated into two groups of plasma rich in growth factors (PRGF) versus hyaluronic acid, Blinding description: Random table number is used to randomize. This is a single blind study and patients are not aware of the type of injected drug.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Seyed Ahmad Raeissadat
• Affiliation: Shahid Beheshti Univeraity of Medical Sciences

• Name: Pegah Yavari
• Affiliation: Physical Medicine and Rehabilitation Department, Shahid Beheshti University of Medical Sciences, Sch

Key inclusion & exclusion criteria

Inclusion criteria: Age between 45-75 years
Symptomatic knee OA with the pain aggravated by weight bearing
Symptoms lasting for at least 6 months despite conservative treatment
Kellgren-Lawrance radiology scoring system scores ranging from 2-3
Exclusion criteria: History of trauma , surgery or any invasive procedure in the affected joint during the past 6 months
Mal-alignment in lower limbs and abnormal blood count or impared coagulation test
Pregnant women
Patients who were under immunosuppressant treatments
Those with an underlying systemic arthropathy (secondary OA)
Patients been treated with angiotensin converting enzyme inhibitors (ACE I) and significant deficiency in glucose 6 - phosphate dehydrogenase (G6PD) level

Age minimum: 45 years
Age maximum: 75 years
Gender: Both

Health Condition(s) or Problem(s) studied

Knee osteoarthritis.
Osteoarthritis of knee

Intervention(s)

Intervention 1: Intervention group 1: plasma rich in growth factor, knee intraarticular injection, 4 to 6 milliliter, 2 times, 3 weeks interval. Intervention 2: Intervention group 2 : Hyaluronic acid (500,000 to 730000 Daltons),3times, weekly.

Primary Outcome(s)

Knee Pain. Timepoint: Before intervention, 6 months & 12months after intervention. Method of measurement: Change of WOMAC questionnaire scores.

Source(s) of Monetary Support

Vice chancellor for research, Shahid Beheshti University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethic Committee of Shahid Beheshti University of Medical Sciences