Chronic Knee Pain, Osteoarthritis, Knee
Conditions
Keywords
Genicular Radiofrequency Ablation, Knee Arthroplasty, Total
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.
Interventions
PROCEDURENerve Block with Radiofrequency Ablation
Ablation of the genicular nerves of the knee by radiofrequency
PROCEDURENerve Block with Sham Radiofrequency Ablation
Genicular radiofrequency of the knee without neurotomy
Sponsors
Abbott Medical Devices
Abbott
Randall Brewer, MD, CPI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in knee pain intensities as indicated on the Visual Analog Scale | Baseline and 6 weeks post-radiofrequency ablation |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in Visual Analog Score of average knee pain | 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 |
| Satisfaction with Radiofrequency Procedure | Baseline to 1 week, 6 weeks, and 12 weeks |
Countries
United States
Outcome results
None listed