Knee Injections for Obese Patients with Knee Arthritis

Phase 4

Recruiting

• Conditions: Osteoarthritis of Knee
• Interventions: Drug: Triamcinolone Acetonide Standard Dose; Drug: Triamcinolone Acetonide Low Dose

• Registration Number: NCT06782529
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-20
• Study Start: 2025-01-24
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-01-24
• Study Completion: 2026-03-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dose Group	Triamcinolone Acetonide Standard Dose	Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.
Lower Dose Group	Triamcinolone Acetonide Low Dose	Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States