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Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee

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: NCT02448407
Recruitment Status : Completed
First Posted : May 19, 2015
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary:

Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees

This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Platelet rich plasma Drug: Hyaluronic acid Phase 3

Detailed Description:
This is the first clinical trial developed following the report of the Spanish Competent Authority on May 23, 2013, considering the PRP as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. It has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the PRP on the premises of a Regional Centre for Transfusions, all belonging to the Public Health System and therefore without commercial interests.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Platelet rich plasma
Three intraarticular injection, one each fifteen days
Biological: Platelet rich plasma
Three intraarticular injections of platelet-rich plasma, one each fifteen days
Other Name: PRP, Platelet Concentrate

Active Comparator: Hyaluronic acid
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days)
Drug: Hyaluronic acid
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)
Other Name: Adant




Primary Outcome Measures :
  1. Changes from baseline Visual Analogue Scale (VAS) value [ Time Frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration ]
    The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees


Secondary Outcome Measures :
  1. Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value [ Time Frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration ]
    KOOS is an instrument to assess the patient's opinion about their knee and associated problems. It includes 5 subscales which measure respectively the pain, symptoms, activities of daily living, sporting activity and quality of life

  2. Effects on quality of life [ Time Frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration ]
    EUROQOL (European Quality of Life) for the evaluation of function and quality of life

  3. All reported adverse events [ Time Frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale)
  • VAS greater than 5
  • Between 40and 80 years of age

Exclusion Criteria:

  • Level IV arthritis of the knee
  • Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months
  • Frontal deformity greater than 10 degrees
  • Ipsilateral pathology of the knee or ankle
  • Range of motion or flexibility of the knee less than 90 degrees
  • Deficit of knee extension greater than 15 degrees
  • Anticoagulation treatment, antiplatelet treatment
  • Hepatopathy
  • Hematological neoplastic pathology
  • Active infection
  • Fibromyalgia
  • Chronic fatigue syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448407


Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
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Principal Investigator: Elvira Montañez Heredia, MD, PhD Hospital Universitario Virgen de la Victoria. Málaga
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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT02448407    
Other Study ID Numbers: EMH-PRP-2013
2013-001303-36 ( EudraCT Number )
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: February 2015
Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
Knee osteoarthritis
Platelet-rich plasma
Pain's treatment
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents