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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01381081

Enrollment

Registered

2011-06-27

Start date

2011-07-31

Completion date

2014-01-31

Last updated

2015-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis, comparing platelet-rich plasma, intra-articular knee injections

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.

Interventions

BIOLOGICALplatelet-rich plasma

a single intra-articular injection

DRUGCorticosteroid

A single betamethasone and bupivacaine intra-articular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026