Genicular Radiofrequency Ablation for Unilateral Knee Arthroplasty Pain Management

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

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.

Key facts

Study ID

NCT02925442

Run by

Lyman Medical Research Foundation, Inc.

People needed

150

Starts

2017-01-25

Expected to finish

2020-02-07

Last updated by the study team

2019-05-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Osteoarthritis of the knee where unilateral knee arthroplasty is indicated by radiograph, function decrease and/or pain indication and readiness to undergo t-RFA, C-RFA or sham treatment.

You may not qualify if…

• □ • NO DAILY OPIOID CONSUMPTION 5 WEEKS PRIOR TO ENROLLMENT
• NO DOCUMENTED NARCOTIC DEPENDENCY OR RECREATIONAL DRUG USE
• NO TOBACCO USAGE WITHIN 2 MONTHS PRIOR TO SURGERY
• NO CONFOUNDING INFLAMMATORY ARTHRITIS DISEASES ARE PRESENT
• NO NEUROPATHY OR NEURO IMPAIRMENT PRESENT
• NO SIGNIFICANT ACUTE ILLNESS OR INFECTION
• NO OTHER CONFOUNDING CHRONIC PAIN
• NO INVESTIGATIONAL AGENT WITHIN 3 MONTHS PRIOR TO ENROLLMENT
• NO DIAGNOSED THROMBOPHILIA
• NO SEVERE CARDIAC OR PULMONARY COMPROMISE
• NO BLEEDING DISORDER(S)
• NO ALLERGIC REACTION TO LOCAL ANESTHESIA, STEROIDS, OR IMPLANT MATERIALS
• NO BREASTFEEDING
• NO PREGNANCY
• NO CONFOUNDING PSYCHIATRIC ILLNESSES
• NO CONFOUNDING MAJOR TRAUMA HARDWARE REMOVALS OR PRIOR TKA *NO CONTRAINDICATED BODY HABITUS TO BE DETERMINED BY A TREATMENT PROVIDER

Where it is running

• Orthopedic Specialty Institute — Coeur d'Alene, Idaho, United States
• Orthopedic Specialty Institute — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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