Platelet-rich Plasma Intra-articular Knee Injections for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

A Prospective, Randomized, Double-blinded, Clinical Trial, Comparing Platelet-rich Plasma Intra-articular Knee Injections Versus Corticosteroid Intra-articular Knee Injections for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381081
• Other study ID #: PRP2010
• Secondary ID: 2010-023977-21
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2011
• Last updated: February 23, 2015
• Start date: July 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2015
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing effect on knee cartilage degenerative injuries are not conclusive to establish a standard of behavior, although PRP has shown to improve joint functionality and reduce pain.

Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to a more effective and lasting functional recovering than corticosteroid intra-articular injections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Degenerative osteoarthritis of the knee confirmed radiologically

• Degenerative osteoarthritis of the knee replacement candidate

• Walking ability in patients with or without external support

• Baseline in pain VAS greater than 60

Exclusion Criteria:

• Neoplastic disease

• Immunosuppressive States

• Patients who received intra-articular injections of steroids, anesthetic and / or hyaluronic acid in the last 3 months.

• Patients who have undergone arthroscopic surgery on the last 3 months

• Patients with involvement of bone metabolism except osteoporosis (Paget's disease, renal osteodystrophy, osteomalacia)

• Fibromyalgia or chronic fatigue syndrome

• Liver disease

• Deficit coagulation (blood dyscrasia)

• Thrombocytopenia

• Anticoagulant treatment

Study Design

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• platelet-rich plasma
a single intra-articular injection

Drug:
• Corticosteroid
A single betamethasone and bupivacaine intra-articular injection

Locations

Country	Name	City	State
Spain	Hospital Universitario Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The value of the visual analogue scale pain (VAS)	The difference between the baseline and the value of the scale one month after treatment	one month after the treatment	No
Secondary	the value of pain visual analog scale according to		4 weeks, 3 and 6 months after treatment	No
Secondary	the functional level of the knee KOOS		4 weeks, 3 and 6 months after treatment	No
Secondary	All reported adverse events		4 weeks, 3 and 6 months after treatment	Yes
Secondary	Scale of the SF36 quality of life		4 weeks, 3 and 6 months after treatment	No