CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 140 enrolled
Drug / intervention
Triamcinolone Acetonide +1 moredrug
Likely dose
Triamcinolone Acetonide 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01230424
NCT01230424Phase 4Completed

Effect of Intra-articular Steroids on Structural Progression of Knee OA: A Randomized Controlled Trial

Tufts Medical Center·interventional·Posted Oct 29, 2010·Updated Jul 31, 2017

In Brief

A Phase 4 clinical trial evaluating Triamcinolone Acetonide and 0.9% Sodium Chloride Injection as Placebo for Osteoarthritis (OA) of the Knee. Completed, enrolled 140 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsBoston University

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2010
Enrollment StartMar 1, 2011
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.7 years ago

Interventions

Triamcinolone Acetonidedrug

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

0.9% Sodium Chloride Injection as Placebodrug

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