Platelet Rich Plasma Injection for Knee Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seok-Jung Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01747018
First received: December 8, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

Platelet-rich plasma (PRP) has been used as an alternative to non-operative treatments for increasing the rate of cure in bone and soft-tissue regeneration, although there are very few clinical studies regarding the treatment of articular cartilage damage. Therefore, our study proposes non-surgical intervention for patients with articular cartilage damage and who are experiencing knee pain caused by this damage.

This study was conducted as a single medical center. It was an uncontrolled, prospective clinical trial, and the study subjects included 44 patients who were suffering from early osteoarthritis and degenerative chondropathy; they were between 18 and 65 years of age and were included in the study irregardless their sex. PRP was injected twice intraarticulary within an interval of four weeks. The pain scores and functional scores were compared two months, four months, and six months following the second injection was completed, using the VAS, the Lysholm knee scale, and the Cincinnati knee rating system.


Condition Intervention Phase
Degenerative Chondropathy
Early Osteoarthritis
Biological: Platelet-rich Plasma
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Intra-articular Injections of Platelet-rich Plasma in Patients With Knee Pain of Articular Cartilage Origin (Degenerative Chondropathy and Early OA).

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    The study subjects followed the instructions given by the doctors during the experiment and the second PRP injection was administered four weeks after the first injection. The pain score and the functional score were measured two months, four months, and six months after the second injection using the Visual Analogue Scale (VAS), the Cincinnati knee rating system (CKRS), and the Lysholm knee scale (LKS). The clinical score was calculated after determining the times of evaluation as level 1 (before the injection), level 2 (the second injection), level 3 (two months after the second injection), level 4 (in four months after the second injection), and level 5 (in six months after the second injection).


Secondary Outcome Measures:
  • Cincinnati knee rating system [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    The study subjects followed the instructions given by the doctors during the experiment and the second PRP injection was administered four weeks after the first injection. The pain score and the functional score were measured two months, four months, and six months after the second injection using the Visual Analogue Scale (VAS), the Cincinnati knee rating system (CKRS), and the Lysholm knee scale (LKS). The clinical score was calculated after determining the times of evaluation as level 1 (before the injection), level 2 (the second injection), level 3 (two months after the second injection), level 4 (in four months after the second injection), and level 5 (in six months after the second injection).


Enrollment: 44
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Platelet-rich Plasma
From all the patients who participated in the clinical trial, 27 ml of blood sample was collected with a 20-G needle from an antecubital vein so that the ratio of the blood and the anti-coagulant became 10:1. The collected blood samples were transferred to a prepared separation kit (Prosys PRP, Seoul, Korea) and underwent centrifugation at the speed of 3,000 RPM for three minutes. The buffy coat layer and the plasma of the upper portion of the layer were obtained and were transferred to a concentration kit (Prosys PRP, Seoul, Korea) using a 10-ml syringe. They again underwent centrifugation at the speed of 3,300 RPM for three minutes in order to obtain concentrated PRP. The injection area was sterilized aseptically and 3-4 cc of PRP were percutaneously injected into the knee joints.
Biological: Platelet-rich Plasma

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 18 and 65 years of age with early osteoarthritis and degenerative chondropathy who had previously taken medication for more than six months and without physical improvement

Exclusion Criteria:

  • advanced osteoarthritis (Kellgren-Lawrence Grading Scale > 2) and inflammatory arthritis with severe deformity exceeding the above range.
  • patellofemoral instability,
  • a history of drug abuse, and/or
  • psychological problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747018

Locations
Korea, Republic of
Uijeongbu St. Mary's Hospital
Uijeongbu, Gyeonggi-do, Korea, Republic of, 480-717
Sponsors and Collaborators
The Catholic University of Korea
  More Information

Additional Information:
No publications provided

Responsible Party: Seok-Jung Kim, Vice-dean , catholic medical college, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01747018     History of Changes
Other Study ID Numbers: UC 10EISI0140
Study First Received: December 8, 2012
Last Updated: December 10, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
Platelet-Rich Plasma
Knee pain
osteoarthritis
degenerative chondropathy
Intraarticular injection

Additional relevant MeSH terms:
Cartilage Diseases
Osteoarthritis
Musculoskeletal Diseases
Connective Tissue Diseases
Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014