Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes

Northwestern University

Status: Completed

Conditions: Arthroplasty, Replacement, Knee

Treatments: Procedure: Simulated Radiofrequency Ablation (RFA); Procedure: Radiofrequency Ablation (RFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02746874

STU00200439

Details and patient eligibility

About

More than 300,000 total knee joint replacement surgeries are performed per year in the United States and safe, effective management of post-operative pain in these patients, often elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be challenging and often require a multidisciplinary, multimodal approach. Opiates have been a mainstay of treatment in the post-operative period with varying degrees of success and complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled pain inhibits early mobilization and hinders post-operative physical therapy.

A new paradigm for treating post-operative pain following total knee replacement may be the use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the anterior capsule and thereby decrease post-operative pain. There are several publications that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis however the use of RFA in the preoperative management of pain in patients undergoing total knee joint replacement has not been investigated.

The aim of this study is to determine if patients undergoing unilateral total knee replacement obtain any post-operative pain relieving benefits from C-RFA of the articular sensory nerve supply when performed prior to surgery, as compared to sham controls who receive only local anesthetic injections of these same nerves without the benefit of ablation treatment.

Enrollment: 70 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• osteoarthritis of the knee scheduled to undergo their first unilateral knee joint replacement
• willingness to undergo fluoroscopy-guided C-RFA or sham treatment

Exclusion criteria

• pregnancy,
• severe cardiac/pulmonary compromise,
• acute illness/infection,
• coagulopathy
• bleeding disorder,
• allergic reactions,
• contraindications to a local anesthetic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Active Group

Active Comparator group

Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Treatment:

Procedure: Radiofrequency Ablation (RFA)

Placebo Group

Sham Comparator group

Description:

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Treatment:

Procedure: Simulated Radiofrequency Ablation (RFA)