NCT04145011

Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain

A Prospective, Multi-center, Randomized, Single Blind Clinical Trial Comparing COOLIEF* Cooled Radiofrequency to Conventional Radiofrequency Ablation of the Genicular Nerves in the Management of Knee Pain in an Osteoarthritic Patient Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Avanos Medical · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is being performed to assess the relative effectiveness of genicular nerve ablation with the COOLIEF\* Cooled Radiofrequency probe to manage moderate to severe knee pain in patients with osteoarthritis (OA) of the knee when compared to radiofrequency ablation using a Standard Radiofrequency probe.

Detailed description

This is a prospective, multi-center, randomized, single-blind comparison study examining the outcomes of subjects with osteoarthritic knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with either Cooled Radiofrequency Ablation (CRFA) or Conventional (Standard) Radiofrequency Ablation (SRFA). Approximately 148 participants from up to 15 sites will be enrolled into this study, with subjects undergoing either CRFA or SRFA in a 1:1 randomization scheme. Follow-up will be conducted for 24 months post-treatment, with the primary endpoint being completed at month 12. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DEVICE	Cooled Radiofrequency	Delivery of energy to ablate sensory nerves via cooled radiofrequency probe (18g, 4mm active tip)
DEVICE	Standard Radiofrequency	Delivery of energy to ablate sensory nerves via non-cooled standard radiofrequency probe (22g, curved 10mm active tip)

Timeline

• Start date: 2019-10-04
• Primary completion: 2021-10-29
• Completion: 2022-10-10
• First posted: 2019-10-30
• Last updated: 2023-08-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study