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

NCT02746874 | Completed Results

• 1 other identifier: STU00200439
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Total Knee Replacement, Replacement of the knee joint,

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption After Surgery

  Pain medication will be calculated into oral morphine equivalents (ME) for the first 48 hours after surgery. Morphine equivalents determine a patient's cumulative intake of any drugs in the opioid class.

  48 hours

Secondary Outcomes (6)

• Oral Morphine Equivalent Milligrams at Baseline.

  Pre operative

• Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative.

  48 hours

• Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative.

  48 hours

• Number of Stairs Climbed on Post-operative Day 2.

  Post operative day 2

• Distance Walked on Post-operative Day 2.

  Post operative day 2

Study Arms (2)

Active Group

ACTIVE COMPARATOR

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.

Procedure: Radiofrequency Ablation (RFA)

Placebo Group

SHAM COMPARATOR

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.

Procedure: Simulated Radiofrequency Ablation (RFA)

Interventions

Radiofrequency Ablation (RFA) PROCEDURE

The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Active Group

Simulated Radiofrequency Ablation (RFA) PROCEDURE

The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Placebo Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Anesthesiology Pain Medicine Center

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 31023931 DERIVED

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

During the study 2016-2018 there was increased patient and physician awareness of opioid abuse epidemic in the US. Fear of opioid addiction and increased pressure on physician may have influenced post operative opioid use and primary outcome

Results Point of Contact

• Title: David Walega, MD
• Organization: Northwestern University

d-walega@northwestern.edu

312-695-0061

Study Officials

• David Walega, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 21, 2016
• Study Start: December 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: December 31, 2017
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)