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Enrolling by Invitation

NCT Number: NCT07544576

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

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.

Enrolling by Invitation

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Key information

Conditions

Knee Arthritis Osteoarthritis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone knee injection without ultrasound guidance

Drug

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

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)

Primary outcomes

  1. Western Ontario and McMaster Universities Index

    Time frame: From enrollment to 3 months

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

  2. Pain Visual Analog Scale

    Time frame: From enrollment to 3 months

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

Secondary outcomes

  1. Immediate change in pVAS (Pain Visual Analog Scale)

    Time frame: From enrollment to immediately after intervention

    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.

Other outcomes

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

    Time frame: From enrollment to 3 months

    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.

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

    Time frame: From enrollment to immediately after the intervention

    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

Sponsors and collaborators

Lead sponsor

Sosi Dzhugarian

Other

Registry information

Official study title

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)

Acronym: PRECISION-Knee

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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