Recruiting

Knee Injections

Sponsor:

Mayo Clinic

Code:

NCT06782529

Conditions

Osteoarthritis of Knee

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Triamcinolone Acetonide Low Dose

Triamcinolone Acetonide Standard Dose

Study Details

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.

Conditions

Osteoarthritis of Knee

Study ID

NCT06782529

Start date

Jan 24, 2025

Status verified date

Feb, 2026

Completion date

Jan 24, 2027

Anticipated

Primary completion date

Jan 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Dose Group

Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.

experimental: Lower Dose Group

Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.

Interventions

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)

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jeffrey P Nadwodny, DO

904 953 6722nadwodny.jeffrey@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Jeffrey P Nadwodny, DO

904 953 6722nadwodny.jeffrey@mayo.edu

Principal Investigator:

Jeffrey P Nadwodny, DO

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 10, 2026

Last verified

Feb, 2026

Keywords

  • Knee Osteoarthritis
  • Corticosteroid Injection
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-10.