NCT02925442

Genicular Radiofrequency Ablation for Unilateral Knee Arthroplasty Pain Management

Comparison Between Cooled (C-RFA) and Standard (t-RFA) Radiofrequency Ablation, and Control for Pain Management Following Unilateral Knee Arthroplasty: A Double-Blinded, Parallel-Grouped, Placebo-Controlled Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Lyman Medical Research Foundation, Inc. · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer minimally invasive, non-surgical, non-opioid pain relief options following surgery. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA, and control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief.

Detailed description

Total knee replacements are a leading orthopedic procedure in the United States totaling 600,000 in 2010, and are anticipated to grow to 3.48 million procedures by 2030. Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Reducing opioid usage and decreasing hospital length of stays are paramount in improving patient care during recovery and rehabilitation, subsequently reducing overall costs associated with total knee replacement. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), which was previously used for spinal pain, is now available for knee pain management. C-RFA, compared to t-RFA, causes large volume spherical lesions and potentially reduces time and fluoroscopic exposure with direct placement techniques. However, both t-RFA and C-RFA offer a minimally invasive, non-surgical, non-opioid pain relief options following surgery. Preliminary reports involving 40 patients who underwent either C-RFA or t-RFA prior to unilateral knee arthroplasty by the investigator indicate both procedures improved postoperative pain assessments and decreased opioid/narcotic utilization. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative C-RFA, t-RFA, and sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief, reduce hospital length of stays and decrease opioid utilization thereby improving patient outcomes and decreasing overall costs.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
PROCEDURE	t-RFA	standard thermal genicular radiofrequency ablation
PROCEDURE	C-RFA	Cooled radiofrequency ablation
PROCEDURE	Control	Simulated radiofrequency ablation for placebo controlled group

Timeline

• Start date: 2017-01-25
• Primary completion: 2020-01-07
• Completion: 2020-02-07
• First posted: 2016-10-05
• Last updated: 2019-05-24

Locations

2 sites across 1 country: United States