Knee Osteoarthritis Clinical Trial
Official title:
Comparison of Acetaminophen and Platelet-rich Plasma Therapy for the Treatment of Knee Osteoarthritis.
Verified date | October 2015 |
Source | Hospital Universitario Dr. Jose E. Gonzalez |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ethics Committee |
Study type | Interventional |
The purpose of this study is to test whether the platelet-rich plasma (PRP) intra-articular
injection therapy is effective as an alternative treatment option in patients with mild knee
osteoarthritis within a controlled randomized study compared to first line treatment
acetaminophen. The investigators will evaluate patients outcome in level of pain, knee
function and quality of life before the treatment and at 6, 12 and 24 weeks follow up.
The study will be complemented with in vitro experiments of human osteoarthritic cartilage
explants culture (treated with PRP) for histological and gene expression assays.
PRP intra-articular injections therapy is effective in patients with mild knee
osteoarthritis by modifying the biochemical joint environment and cartilage regeneration
capability.
Status | Completed |
Enrollment | 543 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Older than 18 years old - Patients who haven't received steroids injection or medical treatment 1 month before the study - Patients with knee osteoarthritis grade I and II (Kellgren-Lawrence scale) - Indistinct gender - Patients who accept to participate in the study with previous signed informed consent Exclusion Criteria: - Patients with knee osteoarthritis grade III and IV (Kellgren-Lawrence scale) - Patients with prosthesis - Pregnancy - Patients with rheumatic diseases - Patients with diabetes, hepatic diseases, coagulopathy, cardiovascular diseases, immunosuppression, infections - Patients taking anticoagulants - Patients with concentrations of hemoglobin under 11 g/dL and platelets under 150,000/uL |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Universitario Dr. José E. González | Monterrey | Nuevo León |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Dr. Jose E. Gonzalez |
Mexico,
Filardo G, Kon E, Pereira Ruiz MT, Vaccaro F, Guitaldi R, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma intra-articular injections for cartilage degeneration and osteoarthritis: single- versus double-spinning approach. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):2082-91. Epub 2011 Dec 28. — View Citation
Spaková T, Rosocha J, Lacko M, Harvanová D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72. — View Citation
van Buul GM, Koevoet WL, Kops N, Bos PK, Verhaar JA, Weinans H, Bernsen MR, van Osch GJ. Platelet-rich plasma releasate inhibits inflammatory processes in osteoarthritic chondrocytes. Am J Sports Med. 2011 Nov;39(11):2362-70. doi: 10.1177/0363546511419278. Epub 2011 Aug 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in SF-12v2 Health Survey | The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 0 weeks | No |
Other | Change in SF-12v2 Health Survey | The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 6 weeks | No |
Other | Change in SF-12v2 Health Survey | The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 12 weeks | No |
Other | Change in SF-12v2 Health Survey | The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 24 weeks | No |
Primary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) | The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | 0 weeks | No |
Primary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) | The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | 6 weeks | No |
Primary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) | The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | 12 weeks | No |
Primary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) | The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | 24 weeks | No |
Secondary | Change in Visual Analog Scale (VAS) | The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain? | 0-24 weeks | No |
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