Clinical trial NCT02746874: Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes
Official title: Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes? A Prospective Randomized Sham-Control Trial With 6 Month Follow Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: Total Knee Replacement, Replacement of the knee joint,
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Opioid Consumption After Surgery
timeFrame: 48 hours
Secondary outcomes:
measure: Oral Morphine Equivalent Milligrams at Baseline.
timeFrame: Pre operative
measure: Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative.
timeFrame: 48 hours
measure: Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative.
timeFrame: 48 hours
measure: Number of Stairs Climbed on Post-operative Day 2.
timeFrame: Post operative day 2
measure: Distance Walked on Post-operative Day 2.
timeFrame: Post operative day 2
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative
timeFrame: 6 months post operative
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Anesthesiology Pain Medicine Center
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: David Walega, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walega D, McCormick Z, Manning D, Avram M. Radiofrequency ablation of genicular nerves prior to total knee replacement has no effect on postoperative pain outcomes: a prospective randomized sham-controlled trial with 6-month follow-up. Reg Anesth Pain Med. 2019 Apr 25:rapm-2018-100094. doi: 10.1136/rapm-2018-100094. Online ahead of print.