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Completed

NCT Number: NCT02448407

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma

Biological

Three intraarticular injections of platelet-rich plasma, one each fifteen days

Other names: PRP, Platelet Concentrate

Hyaluronic acid

Drug

Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)

Other names: Adant

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 19, 2015
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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