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)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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
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Ventura, California, United States, 93003
- Community Memorial Health Center - North Brent Street, 168 North Brent Street, Suite 302, Sports Medicine Clinic, Ventura, California 93003
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Ventura, California, United States, 93003
- Community Memorial Health Center - Pirie Road, 117 Pirie Road, Orthopedic Surgery Clinic, Ojai, California 93023
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Ventura, California, United States, 93003
- Community Memorial Health Center, 1320 Maricopa Highway, Ojai, California 93023
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: 40mg landmark-guided triamcinolone knee joint injection
|
3mL lidocaine (without epinephrine) 1% solution combined with 1mL triamcinolone acetonide injectable solution, USP (40mg per mL)
|
|
Experimental: 20mg ultrasound-guided triamcinolone knee injection
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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
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to 3 months
|
|
Pain Visual Analog Scale
Time Frame: From enrollment to 3 months
|
scale of 0 through 10, with 10 being the highest pain level.
|
From enrollment to 3 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to immediately after intervention
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to 3 months
|
|
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
|
From enrollment to immediately after the intervention
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Griffin Elbert, DO, Community Memorial Healthcare
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 1402691
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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