Radiofrequency For Chronic Knee Pain Post-Arthroplasty

Not Applicable

Completed

• Conditions: Chronic Knee Pain; Osteoarthritis, Knee

• Registration Number: NCT02931435
• Lead Sponsor: Randall Brewer, MD, CPI

Brief Summary

Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.

The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.

Detailed Description

Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.

As the prevalence of knee arthroplasty increases, so does the frequency of revisions. It has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. Pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence.

Genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee OA patients who have had a positive diagnostic block. No study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. The investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.

Study Timeline

• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-13
• Study Start: 2016-12
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Study candidate must provide written informed consent.
• Must be ≥ 50 years of age at the time of consent
• Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent
• Orthopedic evaluation indicating no further surgery is warranted
• Stable pain medication regimen for 30 days prior to baseline visit
• Knee pain is primary pain complaint

Exclusion Criteria

• Acute knee pain
• Connective tissue disorders affecting the knee
• Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator
• Steroid or hyaluronic acid injections into the affected knee in the past 3 months
• Confounding pain conditions of the index leg that may affect medication requirements or study outcomes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean difference in knee pain intensities as indicated on the Visual Analog Scale	Baseline and 6 weeks post-radiofrequency ablation

Secondary Outcome Measures

Name	Time	Method
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Baseline to 1 week, 6 weeks, and 12 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)	Baseline to 1 week, 6 weeks, and 12 weeks
Change of Patient Global Assessment	Baseline to 1 week, 6 weeks, and 12 weeks
Satisfaction with Radiofrequency Procedure	Baseline to 1 week, 6 weeks, and 12 weeks
Rate of procedure-related Adverse Events	From informed consent through study completion, up to 20 weeks
Rate of Serious Adverse Events	From informed consent through study completion, up to 20 weeks
Change in Visual Analog Score of average knee pain	Baseline to 1 week, 6 weeks, and 12 weeks

Trial Locations

Locations (1)

WK River Cities Clinical Research Center; 🇺🇸 Shreveport, Louisiana, United States