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Corticosteroid
Corticosteroid + Anesthetic Injection for Knee Osteoarthritis (Injections Trial)
Phase 1
Recruiting
Research Sponsored by Foundation for Orthopaedic Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84 post procedure (through edc)
Awards & highlights
Injections Trial Summary
This trial will compare pain relief from corticosteroid injections with & without anesthetic & with varying anesthetic amounts. Pain relief and tolerance will be measured post-procedure.
Who is the study for?
This trial is for adults over 18 with moderate osteoarthritis (Kellgren Lawrence Stage II or III) who can give consent. It's not suitable for those outside this group.Check my eligibility
What is being tested?
The study tests pain relief from corticosteroid injections, both with and without anesthetic, in knee osteoarthritis patients. Pain levels are tracked over time to see how long relief lasts and how well different mixtures work.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site, potential allergic reactions to the medications used, and varying responses to pain relief.
Injections Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 84 post procedure (through edc)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84 post procedure (through edc)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Injection for Knee Pain
Secondary outcome measures
Assessment of Knee Pain
Other outcome measures
Medications
Review of Adverse Events
Injections Trial Design
3Treatment groups
Experimental Treatment
Group I: Kenalog with 4ml bupivacaineExperimental Treatment1 Intervention
The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,4ml of bupivacaine. The patients will be randomized into this group.
Group II: Kenalog with 0ml bupivacaineExperimental Treatment1 Intervention
The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0ml of bupivacaine. The patients will be randomized into this group.
Group III: Kenalog with 0.25% bupivacaineExperimental Treatment1 Intervention
The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0.25% of bupivacaine. The patients will be randomized into this group.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Foundation for Orthopaedic Research and EducationLead Sponsor
13 Previous Clinical Trials
1,007 Total Patients Enrolled
Florida Orthopaedic InstituteNETWORK
8 Previous Clinical Trials
400 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a type of arthritis that causes joint inflammation.My arthritis is either mild or very severe.My arthritis is moderate to severe.I have been diagnosed with primary osteoarthritis.I am 18 years or older and can make my own medical decisions.
Research Study Groups:
This trial has the following groups:- Group 1: Kenalog with 0ml bupivacaine
- Group 2: Kenalog with 4ml bupivacaine
- Group 3: Kenalog with 0.25% bupivacaine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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