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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: Platelet rich plasma; Drug: Hyaluronic acid

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Adant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline Visual Analogue Scale (VAS) value	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	Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value	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	Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
Effects on quality of life	EUROQOL (European Quality of Life) for the evaluation of function and quality of life	Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
All reported adverse events		Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Investigators: Principal Investigator: Elvira Montañez Heredia, MD, PhD, Hospital Universitario Virgen de la Victoria. Málaga

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Estimate): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 15, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Knee osteoarthritis; Platelet-rich plasma; Pain's treatment
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: EMH-PRP-2013; 2013-001303-36 (EudraCT Number)