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

Phase 3

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Biological: platelet-rich plasma; Drug: Corticosteroid

• Registration Number: NCT01381081
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Study Start: 2011-07
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platelet-rich plasma intra-articular knee injections	platelet-rich plasma	a single intra-articular injection of PRP in knee osteoarthritis
Corticosteroid intra-articular knee injections	Corticosteroid	a betamethasone and bupivacaine intra-articular injection

Primary Outcome Measures

Name	Time	Method
The value of the visual analogue scale pain (VAS)	one month after the treatment	The difference between the baseline and the value of the scale one month after treatment

Secondary Outcome Measures

Name	Time	Method
the functional level of the knee KOOS	4 weeks, 3 and 6 months after treatment
Scale of the SF36 quality of life	4 weeks, 3 and 6 months after treatment
the value of pain visual analog scale according to	4 weeks, 3 and 6 months after treatment
All reported adverse events	4 weeks, 3 and 6 months after treatment

Trial Locations

Locations (1)

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain