Clinical trial

Knee Injections for Obese Patients With Knee Arthritis

Recruiting now · Phase 4 · 1 countries · Registry ID NCT06782529

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age55 Years to 85 Years

SexAll

Healthy volunteersNot accepted

ConditionOsteoarthritis of Knee

Full registry 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.

Treatments and study arms

Triamcinolone Acetonide Low Dose

Drug

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)

Triamcinolone Acetonide Standard Dose

Drug

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 outcomes

Numerical Pain Scale (NPS)Baseline, 4 weeks, 12 weeks

The Numerical Pain Scale (NPS) uses a 0-10 point rating system in which the patient selects the number that describes their current pain level, where "0" represents "no pain" and "10" represents "the worst pain imaginable"

Knee Injury and Osteoarthritis Outcome score (KOOS)Baseline, 4 weeks, 12 weeks

The Knee Injury and Osteoarthritis Outcome is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Mayo Clinic in Florida🇺🇸 Jacksonville, Florida, United States

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Jeffrey P Nadwodny, DOContact

Email · Call 904 953 6722

Jeffrey P Nadwodny, DOPrincipal Investigator