Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis

University of Texas Southwestern Medical Center1 enrolled

Overview

The purpose of this trial is to determine if radiofrequency ablation plus steroid perineural injections at the knee or hip provide longer pain relief and better function to patients than the current standard of care, perineural steroid injections alone. This pilot study is a prospective two arm randomized trail, all participants will be recruited from the University of Texas Southwestern Medical Center (UTSW) outpatient orthopedic clinic. 40 participants (20 hip and 20 knee OA) will be enrolled into the standard of care arm (treated with steroid injections alone) and 40 participants (20 hip and 20 knee OA) will be enrolled into the investigational arm (treatment with a combination of radiofrequency ablation (RFA) plus steroid injections) for a total of 80 enrolled participants. All subjects will complete a function and pain assessment at the time of injection and three additional time points: 2 weeks, 3 months, and 6 months post injection. This study will use the same knee function questionnaire and frequency currently used in clinic per standard of care. In addition, all participant's surgical history and prior injection history will be reviewed via the Electronic Medical Record (EMR).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis, Knee Osteoarthritis, Hip

Interventions

Radiofrequency Ablation (RFA)PROCEDURE

RFA involves heating of periarticular nerves using continuous RFA (80-90C for 60-90 seconds) that results in electromodulation and denervation reducing pain. It can be done under fluoroscopy or CT guidance. CT guidance has additional benefit of better localization of the nerves, as opposed to simple bony landmarks used in fluoroscopy, since nerve branching variations are common and will be used in this study.

Perineural Steroid InjectionPROCEDURE

Perineural Steroid Injections involve CT guided injection of Local Anesthetic and Steroid into a nerve root of the spine to provide ongoing pain relief.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: (1 \& 2 or 3) 1. Males or females age 18 to 100 years 2. Osteoarthritis of the knee Kellgren-Lawrence grade 3-4 OR 3. Osteoarthritis of the hip Tonnis grades 2 or higher Exclusion Criteria: 1. History of knee or hip replacement 2. History of intra-articular steroid injections within the past 6 weeks 3. Active infection

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Hip Functional score at baseline (pre-procedure)

Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at baseline (pre-procedure). Possible scores range from 1-100, where lower scores indicate worse function.

Time frame: Baseline (Pre-Procedure)

Hip Functional score at 2 weeks post procedure

Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 2 weeks post procedure. Possible scores range from 1-100, where lower scores indicate worse function.

Time frame: 2 weeks post procedure

Hip Functional score at 3 months post procedure

Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 3 months post procedure. Possible scores range from 1-100, where lower scores indicate worse function.

Time frame: 3 months post procedure

Hip Functional score at 6 months post procedure

Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 6 months post procedure. Possible scores range from 1-100, where lower scores indicate worse function.

Time frame: 6 months post procedure

Knee Functional score as measured by standard of care questionnaire for knee OA at baseline (pre-procedure)

Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at baseline (pre-procedure). Possible scores range from 1-100, where higher scores indicate worse function.

Time frame: Baseline (pre-procedure)

Knee Functional score as measured by standard of care questionnaire for knee OA at 2 weeks post procedure

Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 2 weeks post procedure. Possible scores range from 1-100, where higher scores indicate worse function.

Time frame: 2 weeks post procedure

Knee Functional score as measured by standard of care questionnaire for knee OA at 3 months post procedure

Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 3 months post procedure. Possible scores range from 1-100, where higher scores indicate worse function.

Time frame: 3 months post procedure

Knee Functional score as measured by standard of care questionnaire for knee OA at 6 months post procedure

Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 6 months post procedure. Possible scores range from 1-100, where higher scores indicate worse function.

Time frame: 6 months post procedure

Data from ClinicalTrials.gov

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