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Enrolling by invitation NCT07544576

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

Phase IV Interventional Knee Arthritis Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Triamcinolone knee injection without ultrasound guidance, Triamcinolone knee injection with ultrasound guidance.
Who it may be relevant to
Registry conditions: Knee Arthritis Osteoarthritis. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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.

Interventions

  • Drug Triamcinolone knee injection without ultrasound guidance
    3mL lidocaine (without epinephrine) 1% solution combined with 1mL triamcinolone acetonide injectable solution, USP (40mg per mL)
  • 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)

Primary outcome measures

  • Western Ontario and McMaster Universities Index [Time frame: From enrollment to 3 months]
  • Pain Visual Analog Scale [Time frame: From enrollment to 3 months]
Secondary outcome measures (1)
  • Immediate change in pVAS (Pain Visual Analog Scale) [Time frame: From enrollment to immediately after intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Community Memorial Health Center - North Brent Street, 168 North Brent Street, Suite 302, — Ventura
  • Community Memorial Health Center - North Brent Street, 168 North Brent Street, Suite 302, — Ventura
  • Community Memorial Health Center - Pirie Road, 117 Pirie Road, Orthopedic Surgery Clinic, — Ventura
  • Community Memorial Health Center, 1320 Maricopa Highway, Ojai, California 93023 — Ventura

Identifiers

NCT: NCT07544576 · 1402691

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗