Clinical Trial Radar

Name: Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.
Creator: Foundation for Orthopaedic Research and Education
Published: 2023-06-15
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT05906433 (Injections) for Knee Osteoarthritis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis Phase 1 75

Recruiting

Clinical Trial NCT05906433 (Injections) is designed to study Treatment for Knee Osteoarthritis. It is a Phase 1 interventional study that is recruiting, having started on 1 June 2023, with plans to enroll 75 participants. Led by Foundation for Orthopaedic Research and Education, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 9 December 2024.

Brief Summary

To evaluate pain relief from corticosteroid injection with and without anesthetic as well as with variable volume of anesthetic. Pain relief will be measured using the VAS pain score at the time of the injection as well as several time points following the injection to capture pain relief longevity. The investigators intend to evaluate how well the patients tolerate corticosteroid mixtures without anesthetic as well ...Show More

Detailed Description

Primary objective is to evaluate pain relief from corticosteroids, Kenalog without anesthetic as well as with different volumes of anesthetic. The investigators will measure the VAS pain score at the time of the injection as well as several time points following the injection. Additionally, the investigators will evaluate how long the injection provided pain relief for the patient.

The secondary intend is to evaluat...

Official Title

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.

Conditions

Knee Osteoarthritis

Publications

Bedard NA, Dowdle SB, Anthony CA, DeMik DE, McHugh MA, Bozic KJ, Callaghan JJ. Response to Letter to the Editor on "The AAHKS Clinical Research Award: What Are the Costs of Knee Osteoarthritis in the Year Prior to Total Knee Arthroplasty?". J Arthroplasty. 2018 Jan;33(1):307. doi: 10.1016/j.ar...

Other Study IDs

Injections
PI_ PAL_V3_ 8

NCT ID Number

NCT05906433

Start Date (Actual)

2023-06-01

Last Update Posted

2024-12-09

Completion Date (Estimated)

2025-12-01

Enrollment (Estimated)

Study Type

Interventional

PHASE

Phase 1

Status

Recruiting

Keywords

knee injection
Knee osteoarthritis
corticosteroid

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

Single

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalKenalog with 0ml bupivacaine 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.	Kenalog with bupivacaine Injection Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.
ExperimentalKenalog with 4ml bupivacaine 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.	Kenalog with bupivacaine Injection Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.
ExperimentalKenalog with 0.25% bupivacaine 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.	Kenalog with bupivacaine Injection Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection for Knee Pain	Visual Analogue Scale (VAS)	Prior to procedure (in office)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Immediate post procedure (in office)
Injection for Knee Pain	Visual Analogue Scale (VAS)	2 minutes post procedure (in office)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 1 post procedure (phone interview)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 14 post procedure (through EDC)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 42 post procedure (in office)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 84 post procedure (through EDC)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Knee Pain	Global Perceived Improvement	Immediate Post-op (in office)
Assessment of Knee Pain	Global Perceived Improvement	Day 1 post procedure (phone interview)
Assessment of Knee Pain	Global Perceived Improvement	Day 42 post procedure (in office)
Assessment of Knee Pain	Global Perceived Improvement	Day 84 post procedure (through EDC)

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

Accepts Healthy Volunteers

Yes

Patients must be 18 years of age and be able to consent for themselves.
OA grade Kellgren Lawrence Stage II or III.
Diagnosis of primary osteoarthritis.

Patients with other forms of arthritis such as inflammatory arthritis.
History of narcotic use for the past 6 months.
Kellgren Lawrence arthritis grade 1 or 4.
Pregnant women and prisoners.

Foundation for Orthopaedic Research and Education

Florida Orthopaedic Institute

Study Central Contact

Contact: Anne Meredith Baldy, CCRC, (813)978-9700, [email protected]

Contact: Debbi Warren, RN, (813)978-9700, [email protected]

1 Study Locations in 1 Countries

United States

Florida

Florida Orthopaedic Institute, Tampa, Florida, 33637, United States

Brian T Palumbo, MD, Contact, 813-978-9700, [email protected]

Thomas T Bernasek, MD, Contact, (813)978-9700, [email protected]

Recruiting

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis Phase 1 75

Inclusion Criteria

Exclusion Criteria