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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
PRP injection
Placebo
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring PRP PRGF Osteoarthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

platelet reach plasma

placebo

Arm Description

The patients with osteoarthritis who underwent PRP injection.

The patients with osteoarthritis who underwent Normal Saline injection.

Outcomes

Primary Outcome Measures

pain
pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection
physical activity
physical activity of patients which is measured by WOMAC scoring , before injection of PRP& 3,6 and 12 months after last injection.
cartilage repair
The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.

Secondary Outcome Measures

quality of life
Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.
joint replacement
Evaluation the need for joint replacement 12months after injection.

Full Information

First Posted
August 17, 2013
Last Updated
April 24, 2014
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01926327
Brief Title
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

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
PRP PRGF Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
platelet reach plasma
Arm Type
Active Comparator
Arm Description
The patients with osteoarthritis who underwent PRP injection.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The patients with osteoarthritis who underwent Normal Saline injection.
Intervention Type
Biological
Intervention Name(s)
PRP injection
Intervention Description
Injection of PRP in patients with knee osteoarthritis.
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
pain
Description
pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection
Time Frame
3 months
Title
physical activity
Description
physical activity of patients which is measured by WOMAC scoring , before injection of PRP& 3,6 and 12 months after last injection.
Time Frame
3months
Title
cartilage repair
Description
The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.
Time Frame
12months
Secondary Outcome Measure Information:
Title
quality of life
Description
Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.
Time Frame
3months
Title
joint replacement
Description
Evaluation the need for joint replacement 12months after injection.
Time Frame
12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Department of Regenerative Medicine Of Royan Institute & cell therapy center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohsen Emadedin, MD
Organizational Affiliation
Orthoped scientist in Royan Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ali Mirazimi Bafghi, MD
Organizational Affiliation
Regenerative Medicine Department of Royan Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://royaninstitute.org
Description
Related Info

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

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