Platelet Rich Plasma Injection for Knee Pain

NCT01747018 | Completed Phase 1 DMC

• 1 other identifier: UC 10EISI0140
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenerative Chondropathy; Early Osteoarthritis

Keywords

Platelet-Rich Plasma; Knee pain; osteoarthritis; degenerative chondropathy; Intraarticular injection

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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).

  6 month follow up

Secondary Outcomes (1)

• Cincinnati knee rating system

  6 month follow up

Study Arms (1)

Platelet-rich Plasma

EXPERIMENTAL

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

Interventions

Platelet-rich Plasma BIOLOGICAL

Platelet-rich Plasma

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Uijeongbu St. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, 480-717, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-dean , catholic medical college

Study Record Dates

• First Submitted: December 8, 2012
• First Posted: December 11, 2012
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

KR (1)