MedTrace Logo

Effect of Steroid Injections in a Knee With Osteoarthritis

NCT01230424 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2017-07-31

Study results available
· View outcomes & findings →

Summary

A steroid (triamcinolone) 40 mg will be compared to placebo in a randomized placebo-controlled clinical trial testing the effect of this steroid versus placebo given into the study knee joint that has osteoarthritis (OA). The knee injection will be given once every 12 weeks over two years for a total of eight knee injections. How well each participant tolerates each injection and all the injections over time will be assessed. The safety of getting a knee injection every 12 weeks will be assessed by collecting reported adverse effects, knee examinations, and clinical laboratory tests. Participants will complete questionnaires, X-ray, MRIs, and bone density tests as part of this study.

Conditions

  • Osteoarthritis (OA) of the Knee

Interventions

DRUG

Triamcinolone Acetonide

40 mg into the study knee joint every 12 weeks for a total of 8 injections.

DRUG

0.9% Sodium Chloride Injection as Placebo

Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.

Sponsors & Collaborators

  • Boston University

    collaborator OTHER

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Timothy E. McAlindon, MD, MPH · Tufts Medical Center / Division of Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01230424 on ClinicalTrials.gov