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

Non-Inferiority Study Comparing Treatment of Primary Knee Osteoarthritis With Intra-Articular Triamcinolone Injections Using 40mg With Landmark Guidance and 20mg With Ultrasound Guidance: The PRECISION-Knee Trial (PRospective Evaluation of the Clinical Impact of Steroid Injection Options iN Knee Osteoarthritis)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Knee Arthritis Osteoarthritis
• Intervention / Treatment: Drug: Triamcinolone knee injection without ultrasound guidance; Combination product: Triamcinolone knee injection with ultrasound guidance

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • Community Memorial Health Center - North Brent Street, 168 North Brent Street, Suite 302, Orthopedic Surgery Clinic, Ventura, California 93003
    • Ventura, California, United States, 93003
      • Community Memorial Health Center - North Brent Street, 168 North Brent Street, Suite 302, Sports Medicine Clinic, Ventura, California 93003
    • Ventura, California, United States, 93003
      • Community Memorial Health Center - Pirie Road, 117 Pirie Road, Orthopedic Surgery Clinic, Ojai, California 93023
    • Ventura, California, United States, 93003
      • Community Memorial Health Center, 1320 Maricopa Highway, Ojai, California 93023

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 40mg landmark-guided triamcinolone knee joint injection	Drug: Triamcinolone knee injection without ultrasound guidance; 3mL lidocaine (without epinephrine) 1% solution combined with 1mL triamcinolone acetonide injectable solution, USP (40mg per mL)
Experimental: 20mg ultrasound-guided triamcinolone knee injection	Combination product: Triamcinolone knee injection with ultrasound guidance; 3mL lidocaine (without epinephrine) 1% solution combined with 0.5mL triamcinolone acetonide injectable solution, USP (40mg per mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate change in pVAS (Pain Visual Analog Scale)	pVAS scores from baseline and immediately after injection will be compared. pVAS is on a scale of 0 through 10, with 10 being the highest pain level.	From enrollment to immediately after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
relationship of Kellgren-Lawrence (KL) score to primary and secondary outcomes	KL is a standard scoring system on a scale of 0 through 4, with 4 representing severe osteoarthritis, based on imaging for that knee joint.	From enrollment to 3 months
Patients' ratings of the physician's confidence obtained through a multiple choice question.	Comparison of the patients' ratings of the physician's confidence based on whether ultrasound guidance was utilized or not. Patient selects one choice from the following 5 options in response to the statement that the physician who injected their knee was confident: 1 - Strongly Disagree, 2 - Disagree, 3 - Neutral, 4 - Agree, 5 - Strongly Agree	From enrollment to immediately after the intervention

Collaborators and Investigators

• Sponsor: Sosi Dzhugarian
• Investigators: Principal Investigator: Griffin Elbert, DO, Community Memorial Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1402691

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes