Knee Injections for Obese Patients With Knee Arthritis

Comparison of Varying Doses of Steroid for Intra-articular Knee Injections

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06782529

Enrollment

Registered

2025-01-20

Start date

2025-01-24

Completion date

2027-01-24

Last updated

2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of Knee

Keywords

Knee Osteoarthritis, Corticosteroid Injection, Obesity

Brief summary

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

DRUGTriamcinolone 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)

DRUGTriamcinolone 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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTJeffrey P Nadwodny, DO

nadwodny.jeffrey@mayo.edu904 953 6722

PRINCIPAL_INVESTIGATORJeffrey P Nadwodny, DO

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026