Early Osteoarthritis Clinical Trial
Official title:
Intra-articular Injections of Platelet-rich Plasma in Patients With Knee Pain of Articular Cartilage Origin (Degenerative Chondropathy and Early OA).
Verified date | December 2012 |
Source | The Catholic University of Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | September 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Uijeongbu St. Mary's Hospital | Uijeongbu | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
The Catholic University of Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Cincinnati knee rating system | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04267510 -
Clinical and Molecular Aspects of Early Osteoarthritis
|