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Comparison of Acetaminophen and PRP Therapy for Knee OA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01782885
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Mario Alberto Simental Mendia, M Sc, Principal Investigator, Hospital Universitario Dr. Jose E. Gonzalez

Tracking Information
First Submitted Date  ICMJE January 30, 2013
First Posted Date  ICMJE February 4, 2013
Results First Submitted Date  ICMJE September 21, 2015
Results First Posted Date  ICMJE November 20, 2015
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 0 weeks ]
    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.
  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 6 weeks ]
    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.
  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 12 weeks ]
    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.
  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 24 weeks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 3, 6, 12 months ]
The WOMAC evaluation will be performed on patients who received the treatment at 3,6 and 12 months after treatment finished.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
Change in Visual Analog Scale (VAS) [ Time Frame: 0-24 weeks ]
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?
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
Change in Visual Analog Scale (VAS) [ Time Frame: 3, 6, 12 months ]
The VAS evaluation will be performed on patients who received the treatment at 3,6 and 12 months after treatment finished.
Current Other Pre-specified Outcome Measures
 (submitted: October 19, 2015)
  • Change in SF-12v2 Health Survey [ Time Frame: 0 weeks ]
    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.
  • Change in SF-12v2 Health Survey [ Time Frame: 6 weeks ]
    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.
  • Change in SF-12v2 Health Survey [ Time Frame: 12 weeks ]
    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.
  • Change in SF-12v2 Health Survey [ Time Frame: 24 weeks ]
    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.
Original Other Pre-specified Outcome Measures
 (submitted: January 31, 2013)
Change in SF-12v2 Health Survey [ Time Frame: 3, 6, 12 months ]
The SF-12v2 Health Survey will be performed on patients who received the treatment at 3,6 and 12 months after treatment finished.
 
Descriptive Information
Brief Title  ICMJE Comparison of Acetaminophen and PRP Therapy for Knee OA
Official Title  ICMJE Comparison of Acetaminophen and Platelet-rich Plasma Therapy for the Treatment of Knee Osteoarthritis.
Brief Summary

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.

Detailed Description

This is a randomized controled study. Patients enroled in the study will be divided into two groups (calculated n=30 per group). One group will be treated with acetaminophen (500 mg/8 h) for 6 weeks, the experimental group will receive a total of 3 intra-articular injections of PRP, one injection every 2 weeks. The intake of any other analgesic or anti-inflammatory drug will be prohibited in patients from two groups.

For those who received 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 erythrocyte 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • 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 (6 weeks total).
  • Drug: Acetaminophen
    Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts (6 weeks total).
Study Arms  ICMJE
  • Active Comparator: Acetaminophen
    Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts.
    Intervention: Drug: Acetaminophen
  • 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
    Intervention: Procedure: Intra-articular injection of PRP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2015)
543
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2013)
60
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01782885
Other Study ID Numbers  ICMJE BI13-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mario Alberto Simental Mendia, M Sc, Principal Investigator, Hospital Universitario Dr. Jose E. Gonzalez
Study Sponsor  ICMJE Hospital Universitario Dr. Jose E. Gonzalez
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hospital Universitario Dr. Jose E. Gonzalez
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP