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

The University of Texas System (UT)

Status: Terminated

Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee

Treatments: Procedure: Radiofrequency Ablation (RFA); Procedure: Perineural Steroid Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05490355

STU-2022-0337

Details and patient eligibility

About

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).

Enrollment: 1 patient

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Perineural Steroid Injections Alone

Active Comparator group

Description:

Participants assigned to this study arm will receive only Perineural Steroid Injections per clinical standards. Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.

Treatment:

Procedure: Perineural Steroid Injection

Perineural Steroid Injections Plus Radiofrequency Ablation

Experimental group

Description:

Participants assigned to this study arm will receive Perineural Steroid Injections plus Radiofrequency Ablation per clinical standards. Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.

Treatment:

Procedure: Perineural Steroid Injection

Procedure: Radiofrequency Ablation (RFA)