Effect of Steroid Injections in a Knee With Osteoarthritis

Tufts University

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis (OA) of the Knee

Treatments

Drug: Triamcinolone Acetonide

Drug: 0.9% Sodium Chloride Injection as Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01230424

NIH NIAMS R01-AR057802

Tufts MC IRB Protocol # 9417 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This study was a two-year stratified and block-randomized double-blind, placebo controlled clinical trial of the effect of intra-articular triamcinolone 40 mg injectable suspension, administered every 3 months over two years (for a total of 8 doses). The randomization was stratified by the baseline radiographic severity of knee OA (Kellgren and Lawrence grade of 2 or 3) and gender. An interim analysis would have been conducted after the first half of participants has completed the trial. This interim analysis would have allowed the trial to be stopped early for either success or futility, or allow the trial to continue if neither success nor futility has been established. However, the plan for interim analysis was eliminated with the support of the DSMB because of feasibility issues for completing cartilage measurements contemporaneously and because early trial cessation would preclude analysis of informative secondary outcomes. The primary structural outcome objective in this study was cartilage volume loss; secondary structural outcomes included peri-articular bone marrow lesions (BML), tibial peri-articular bone density ratio (paBMD). The primary clinical outcome objective was the pain domain of the WOMAC© LK3.1; secondary clinical outcomes included WOMAC© LK3.1 stiffness and function scores and physical function tests.

Enrollment

140 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female or Male, Age ≥ 45 years
Chronic knee discomfort based on affirmative response to the question "During the past 12 months, have you had any pain, aching, or stiffness in or around your knee(s) on most days for at least one month?"
Baseline (Month 0) Pain score >2 on at least one of the WOMAC weight-bearing pain questions; and total weight-bearing pain score <8
Tibiofemoral or patellofemoral OA on posterior-anterior weight-bearing semi-flexed or lateral knee radiographs with severity equivalent to Kellgren and Lawrence grade 2 or 3
Evidence of synovitis on ultrasound at screening
Clinical examination confirming knee pain or discomfort referable to the knee joint
Prepared to discontinue NSAID(s)/analgesic(s) for 2 days prior to each assessment

Exclusion criteria

Prior septic (study) knee joint
Prior reconstructive surgery in the study knee
Prior osteonecrosis (avascular necrosis of bone)
Chronic use of oral corticosteroids; knee intra-articular corticosteroid injection within 3 months of Month 0 (baseline) visit
Ongoing use of doxycycline, indomethacin, glucosamine and/or chondroitin; or use of these within 2 months of Screening visit
Evidence of other inflammatory joint disease (e.g., gout, CPPD)
Serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial such as uncontrolled diabetes, uncontrolled hypertension, opiate dependency
Plan to permanently relocate from the region, or take an extended vacation for greater than 3 months during the trial period
Planned arthroscopy and/or arthroplasty in the study knee.
Any contra-indication to having an MRI
Inability to speak or comprehend English