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NCT Number: NCT06782529

Knee Injections for Obese Patients With Knee Arthritis

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.

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Key information

Conditions

Osteoarthritis of Knee Arthritis Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Osteoarthritis, Knee Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Jeffrey P Nadwodny, DO

CONTACT

[email protected]

904 953 6722

Jeffrey P Nadwodny, DO

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Numerical Pain Scale (NPS)

    Time frame: 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"

  2. Knee Injury and Osteoarthritis Outcome score (KOOS)

    Time frame: 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 contacts

Contact information is provided by the study sponsor or research team.

Jeffrey P Nadwodny, DO

CONTACT

[email protected]

904 953 6722

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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