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Comparison of Acetaminophen and PRP Therapy for Knee OA

NCT01782885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 543

Last updated 2015-11-20

Study results available
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Summary

The purpose of this study is to test whether the platelet-rich plasma (PRP) intra-articular injection therapy is effective as an alternative treatment option in patients with mild knee osteoarthritis within a controlled randomized study compared to first line treatment acetaminophen. The investigators will evaluate patients outcome in level of pain, knee function and quality of life before the treatment and at 6, 12 and 24 weeks follow up.

The study will be complemented with in vitro experiments of human osteoarthritic cartilage explants culture (treated with PRP) for histological and gene expression assays.

PRP intra-articular injections therapy is effective in patients with mild knee osteoarthritis by modifying the biochemical joint environment and cartilage regeneration capability.

Conditions

Interventions

PROCEDURE

Intra-articular injection of PRP

Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks total).

DRUG

Acetaminophen

Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts (6 weeks total).

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

  • Mario A. Simental, MSc · Universidad Autónoma de Nuevo León, Facultad de Medicina

  • Felix Vilchez, PhD · Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José E. González

  • Herminia G Martínez, PhD · Universidad Autónoma de Nuevo León, Facultad de Medicina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Mexico

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01782885 on ClinicalTrials.gov