Knee Injections for Obese Patients With Knee Arthritis

NCT06782529 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-005200
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Knee Osteoarthritis; Corticosteroid Injection; Obesity

Outcome Measures

Primary Outcomes (2)

• Numerical Pain Scale (NPS)

  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"

  Baseline, 4 weeks, 12 weeks

• Knee Injury and Osteoarthritis Outcome score (KOOS)

  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.

  Baseline, 4 weeks, 12 weeks

Study Arms (2)

Standard Dose Group

ACTIVE COMPARATOR

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

Drug: Triamcinolone Acetonide Standard Dose

Lower Dose Group

EXPERIMENTAL

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

Drug: Triamcinolone Acetonide Low Dose

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)

Lower Dose Group

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)

Standard Dose Group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with BMI ≥30 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jeffrey P Nadwodny, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey P Nadwodny, DO

CONTACT

904 953 6722; nadwodny.jeffrey@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Family Medicine

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: January 24, 2025
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): January 24, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)