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

NCT ID: NCT02448407

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-11-30

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.

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet rich plasma

Three intraarticular injection, one each fifteen days

Group Type: EXPERIMENTAL

Platelet rich plasma

Intervention Type: BIOLOGICAL

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

Hyaluronic acid

Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days)

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type: DRUG

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

Interventions

Platelet rich plasma

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

Intervention Type: BIOLOGICAL

Hyaluronic acid

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

Intervention Type: DRUG

Other Intervention Names

PRP, Platelet Concentrate; Adant

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elvira Montañez Heredia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Victoria. Málaga

Other Identifiers

2013-001303-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EMH-PRP-2013

Identifier Type: -

Identifier Source: org_study_id