Knee Injections for Obese Patients With Knee Arthritis

Conditions

• Osteoarthritis of Knee

Eligibility Criteria

Sex

ALL

Age

55 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• 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)

Study Details

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.

Key Dates

Start date

Jan 24, 2025

Status verified

Feb 2026

Primary completion

Jan 24, 2027

Completion

Jan 24, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Numerical Pain Scale (NPS) [ Time Frame: Baseline, 4 weeks, 12 weeks ]

Central Contacts

• Jeffrey P Nadwodny, DO
  904 953 6722
  [email protected]

Locations (1)

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