Comparing Treatment of Knee Osteoarthritis With Triamcinolone Injections Using 40mg With Landmark Guidance and 20mg With Ultrasound Guidance

NCT07544576 | Enrolling By Invitation Phase 4 FDA Drug FDA Device

• 1 other identifier: 1402691
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine whether a lower dose of corticosteroid injection with ultrasound-guidance for the treatment of knee osteoarthritis can be as effective as a higher dose that is landmark-guided. With landmark-guided dosing, it may be reasonable to use a higher amount of corticosteroid in order to ensure a sufficient amount of the medication is administered, however these injections carry the risk of side effects. Alternatively, with the use of ultrasound, it may be reasonable to use less corticosteroid, possibly decreasing the risk of side effects and increasing patient satisfaction.

Conditions

Knee Arthritis Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Western Ontario and McMaster Universities Index

  Scores are on a scale of 0 through 96, with a higher score indicating a worse function level.

  From enrollment to 3 months

• Pain Visual Analog Scale

  scale of 0 through 10, with 10 being the highest pain level.

  From enrollment to 3 months

Secondary Outcomes (1)

• Immediate change in pVAS (Pain Visual Analog Scale)

  From enrollment to immediately after intervention

Other Outcomes (2)

• relationship of Kellgren-Lawrence (KL) score to primary and secondary outcomes

  From enrollment to 3 months

• Patients' ratings of the physician's confidence obtained through a multiple choice question.

  From enrollment to immediately after the intervention

Study Arms (2)

40mg landmark-guided triamcinolone knee joint injection

ACTIVE COMPARATOR

Drug: Triamcinolone knee injection without ultrasound guidance

20mg ultrasound-guided triamcinolone knee injection

EXPERIMENTAL

Combination Product: Triamcinolone knee injection with ultrasound guidance

Interventions

Triamcinolone knee injection without ultrasound guidance DRUG

3mL lidocaine (without epinephrine) 1% solution combined with 1mL triamcinolone acetonide injectable solution, USP (40mg per mL)

40mg landmark-guided triamcinolone knee joint injection

Triamcinolone knee injection with ultrasound guidance COMBINATION_PRODUCT

3mL lidocaine (without epinephrine) 1% solution combined with 0.5mL triamcinolone acetonide injectable solution, USP (40mg per mL)

20mg ultrasound-guided triamcinolone knee injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have already been evaluated within at least one of the 4 study clinics with any of the 3 providers who will be administering the treatment
• Males or females age 50 and older
• Already had completion of imaging of the affected knee(s) via radiography and/or MRI
• Imaging demonstrates osteoarthritis of any severity
• Diagnosis of primary osteoarthritis of one or both knees
• One or more symptoms associated with the osteoarthritis of at least one knee
• Patients able to provide informed consent in English and/or Spanish

You may not qualify if:

• Skin infection at or near area of injection site
• Recent fracture of the same knee joint within past 6 months
• Uncontrolled bleeding disorder
• Intra-articular corticosteroid injection within past 3 months
• Intra-articular HA injection within the past 3 months
• Intra-articular PRP injection within the past 3 months
• Presence of prosthetic knee joint in symptomatic knee
• Inability to report symptoms due to cognitive impairment
• Complete inability to ambulate, even with assistive device
• Any person who is pregnant or less than 1 year post-menopause

Sponsors & Collaborators

• Sosi Dzhugarian: lead

Study Sites (4)

Community Memorial Health Center - North Brent Street, 168 North Brent Street, Suite 302, Orthopedic Surgery Clinic, Ventura, California 93003

Ventura, California, 93003, United States

Location

Community Memorial Health Center - North Brent Street, 168 North Brent Street, Suite 302, Sports Medicine Clinic, Ventura, California 93003

Ventura, California, 93003, United States

Location

Community Memorial Health Center - Pirie Road, 117 Pirie Road, Orthopedic Surgery Clinic, Ojai, California 93023

Ventura, California, 93003, United States

Location

Community Memorial Health Center, 1320 Maricopa Highway, Ojai, California 93023

Ventura, California, 93003, United States

Location

Study Officials

• Griffin Elbert, DO

  Community Memorial Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Internal Medicine Physician

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 22, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (4)