Recruiting NCT06782529
Knee Injections for Obese Patients With Knee Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Triamcinolone Acetonide Low Dose, Triamcinolone Acetonide Standard Dose.
- Who it may be relevant to
- Registry conditions: Osteoarthritis of Knee. Basic parameters: 55 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Varying Doses of Steroid for Intra-articular Knee Injections
Overview
The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.
Interventions
- Drug Triamcinolone Acetonide Low Dose
Subjects will receive a reduced dose of 20mg of triamcinolone acetonide. Total injection volume of 5ml, consisting of: * 0.5ml triamcinolone acetonide (20mg) * 4.5ml lidocaine (45mg) - Drug Triamcinolone Acetonide Standard Dose
Subjects will receive the standard of care dose of 40mg triamcinolone acetonide Total injection volume of 5ml, consisting of: * 1ml triamcinolone acetonide (40mg) * 4ml lidocaine (40mg)
Primary outcome measures
- Numerical Pain Scale (NPS) [Time frame: Baseline, 4 weeks, 12 weeks]
- Knee Injury and Osteoarthritis Outcome score (KOOS) [Time frame: Baseline, 4 weeks, 12 weeks]
Eligibility criteria
Inclusion criteria
- Patients with BMI ≥30 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis.
Exclusion criteria
- BMI < 30 kg/m2
- Uncontrolled diabetics with a hemoglobin A1c > 8%
- No other treatment within the time frame of the study.
- Patients that are undergoing physical therapy at the time of the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT06782529 · 24-005200