Preop Cooled Radiofrequency Ablation for Total Knee Replacement

NCT03893292 | Withdrawn FDA Device

• 1 other identifier: 2018-1149
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. However, 20% of patients continue to experience pain after surgery. There is currently no standardized pain management protocol for pain after total knee replacement. Cooled radiofrequency ablation has been used successfully to alleviate spin-related pain and has recently been approved by the FDA to treat chronic knee arthritic pain. This pilot study aims to collect preliminary data on the use of cooled radiofrequency ablation in patients undergoing total knee replacement.

Conditions

Postoperative Pain; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain

  Pain will be assessing on a 0-10 scale, where 0=no pain and 10=most pain.

  Up to 1 year post-total knee replacement

Secondary Outcomes (2)

• Knee Disability

  Up to 1 year post-total knee replacement

• Function assessed using the PROMIS-physical function computer adaptive test

  Up to 1 year post-total knee replacement

Study Arms (1)

Preoperative cooled radiofrequency ablation

Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement.

Procedure: Total knee replacement; Device: COOLIEF

Interventions

Total knee replacement PROCEDURE

Patients will undergo total knee replacement surgery.

Preoperative cooled radiofrequency ablation

COOLIEF DEVICE

The superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated.

Preoperative cooled radiofrequency ablation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing unilateral primary total knee replacement for the treatment of knee osteoarthritis

You may qualify if:

• Patients undergoing unilateral primary total knee replacement for osteoarthritis
• Pain \>6 (on a scale of 0-10)
• Body mass index: 21-35 kg/m2

You may not qualify if:

• Age \<65 years
• Patients who are wheelchair bound
• History of inflammatory arthritis or rheumatic disease
• Body mass index \<21 or \>35 kg/m2
• Chronic opioid use
• Pregnant women
• Non-English speaking

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Jonathan Kirschner, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: January 24, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)