In Vivo and in Vitro Evaluation of PRP Therapy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||In Vivo and in Vitro Evaluation of the Platelet-rich Plasma Treatment in Osteoarthritis.|
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 0, 6, 12, 24 weeks ] [ Designated as safety issue: No ]The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished.
- Change in Visual Analog Scale (VAS) [ Time Frame: 0, 6, 12, 24 weeks ] [ Designated as safety issue: No ]The VAS evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished.
- Change in SF-12v2 Health Survey [ Time Frame: 0, 6, 12, 24 weeks ] [ Designated as safety issue: No ]The SF-12v2 Health Survey will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
No Intervention: Acetaminophen
Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts.
Experimental: Intra-articular injection of PRP
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks
Procedure: Intra-articular injection of PRP
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks.
This is a randomized controled study. Patients enroled in the study will be divided into two groups (calcuated n=30 per group). One group will be treated with acetaminophen (500 mg/8 h) for 6 weeks, the experimental group will recieve a total of 3 intra-articular injections of PRP, one injection every 2 weeks. The intake of any other analgesic or anti-inflammarory drug will be prohibited in patients from two groups.
For those who recieved the infiltrations, the procedure consist of a 27-mL venous blood sample in 6 vacutainer tubes with sodium citrate 0.109 M for each injection. Samples are gently agitated to ensure mixing the anticoagulant with the blood. An extra tube with anticoagulated EDTA blood is obtained for initial platelet count. Blood samples are centrifuged for 10 minutes at 1800 rpm to separate the erithrocyte layer. The upper plasma layer is carefully collected in a new sterile propylene tube trying not to remove the leukocyte layer. Plasma from all tubes is centrifuged again for 12 minutes at 3400 rpm to obtain a two-part plasma: the upper part consisting on platelet-poor plasma and lower part consisting of platelet-rich plasma (PRP). The platelet-poor plasma is discarded to obtain a final volume of 3 mL. This volume, consisting of PRP, is mixed carefully through pipetting to resuspend platelets and it was then transferred to a new sterile glass tube. An aliquot of the final PRP is sent to the laboratory for platelet count. All open handling sample procedures are performed within a high-efficiency particulate air-filtered laminar flow hood.
Application of injections is carry out after disinfection of skin in the knee joint area. After local anesthesia with lidocaine chlorohydrate, platelets are activated using 10% calcium gluconate solution and the liquid PRP is injected in a sterile condition using a 22 G needle. The needle is inserted using the superolateral approach in an angle of approximately 45°.
Patients from PRP group will be asked to flex and extend their knees immediately after injection so that PRP could distribute adequately across the joint space. After 5-10 minutes of observation the patients are sent home with written indications including to have relative rest 24 to 48 hours after the injection, the use of cold therapy for 15 minutes three times a day and 500 mg of acetaminophen in case of pain and inflammation.
The use of NSAIDs or any steroids is prohibited. All the patients will be evaluated before the beginning of their respective treatment and at 6, 12 and 24 weeks after. Three different scales are used to evaluate clinical outcome, the VAS (Visual Analog Scale) that scores pain level, the WOMAC (Western Ontario and McMaster Universities Arthritis Index) which assesses pain, articular stiffness and functional limitation, and the Spanish (México) version of the SF-12 (Short Form-12) for assessment of quality of life.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782885
|Contact: Felix Vilchez, PhD||+52 (81) 8346 firstname.lastname@example.org|
|Hospital Universitario Dr. José E. González||Recruiting|
|Monterrey, Nuevo León, Mexico, 64460|
|Contact: Mario A. Simental, MSc email@example.com|
|Contact: Felix Vilchez, PhD firstname.lastname@example.org|
|Principal Investigator: Mario A. Simental, MSc|
|Principal Investigator: Felix Vilchez, PhD|
|Principal Investigator:||Mario A. Simental, MSc||Universidad Autónoma de Nuevo León, Facultad de Medicina|
|Study Director:||Felix Vilchez, PhD||Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José E. González|
|Study Director:||Herminia G Martínez, PhD||Universidad Autónoma de Nuevo León, Facultad de Medicina|