Knee Injections for Obese Patients With Knee Arthritis

NCT ID: NCT06782529

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-24

Study Completion Date

2026-03-24

Brief Summary

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The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.

Detailed Description

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Conditions

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Osteoarthritis of Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Dose Group

Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide Standard Dose

Intervention Type DRUG

Subjects will receive the standard of care dose of 40mg triamcinolone acetonide

Total injection volume of 5ml, consisting of:

* 1ml triamcinolone acetonide (40mg)
* 4ml lidocaine (40mg)

Lower Dose Group

Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.

Group Type EXPERIMENTAL

Triamcinolone Acetonide Low Dose

Intervention Type DRUG

Subjects will receive a reduced dose of 20mg of triamcinolone acetonide.

Total injection volume of 5ml, consisting of:

* 0.5ml triamcinolone acetonide (20mg)
* 4.5ml lidocaine (45mg)

Interventions

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Triamcinolone Acetonide Low Dose

Subjects will receive a reduced dose of 20mg of triamcinolone acetonide.

Total injection volume of 5ml, consisting of:

* 0.5ml triamcinolone acetonide (20mg)
* 4.5ml lidocaine (45mg)

Intervention Type DRUG

Triamcinolone Acetonide Standard Dose

Subjects will receive the standard of care dose of 40mg triamcinolone acetonide

Total injection volume of 5ml, consisting of:

* 1ml triamcinolone acetonide (40mg)
* 4ml lidocaine (40mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Patients with BMI ≥30 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis.

Exclusion Criteria

* BMI \< 30 kg/m2
* Uncontrolled diabetics with a hemoglobin A1c \> 8%
* No other treatment within the time frame of the study.
* Patients that are undergoing physical therapy at the time of the study.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jeff P. Nadwodny

Assistant Professor of Family Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey P Nadwodny, DO

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeffrey P Nadwodny, DO

Role: CONTACT

904 953 6722

Facility Contacts

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Jeffrey P Nadwodny, DO

Role: primary

904 953 6722

Related Links

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Other Identifiers

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24-005200

Identifier Type: -

Identifier Source: org_study_id

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