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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448407
• Other study ID #: EMH-PRP-2013
• Secondary ID: 2013-001303-36
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2015
• Last updated: May 15, 2015
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Platelet rich plasma
Three intraarticular injections of platelet-rich plasma, 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	All reported adverse events		Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration	Yes