NCT02947321

Brief Summary

Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 26, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

October 25, 2016

Last Update Submit

October 1, 2020

Conditions

Knee Arthroplasty, TotalOsteoarthritisRadiologic Tibiofemoral Osteoarthritis

Keywords

Radiofrequency ablation

Outcome Measures

Primary Outcomes (2)

  • Comparison of pain score at rest

    Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)

    On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.

  • Comparison of pain score with ambulation

    Pain score with ambulation using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)

    On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.

Secondary Outcomes (11)

  • Comparison of PROMIS physical function score

    On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52

  • Comparison of PROMIS global health score

    On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52

  • Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)

    On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52

  • Comparison of 7-point Patient Global Impression of Change (PGIC)

    Preoperatively on the day of surgery, and at week 2, 6, 24, and 52

  • Comparison of Mobility using Timed Up and Go Test (TUG)

    Day of genicular RFA or sham procedure, and postoperative day 1

  • +6 more secondary outcomes

Study Arms (2)

RFA Group

EXPERIMENTAL

A genicular nerve RFA will be performed prior to planned total knee arthroplasty.

Procedure: Genicular Nerve RFA

Control Group

SHAM COMPARATOR

A sham genicular nerve RFA will be performed prior to planned total knee arthroplasty.

Procedure: Sham Genicular Nerve RFA

Interventions

Genicular Nerve RFAPROCEDURE

Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. RFA probes will be placed and connected to the RFA generator and the generator is activated. The RFA is performed.

RFA Group
Sham Genicular Nerve RFAPROCEDURE

Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. The RFA probes for the control group will not be connected to the RFA generator (no neurotomy); however, the generator will still be activated to mimic the RFA group.

Control Group

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgical candidate for total knee arthroplasty secondary to osteoarthritis
  • Radiologic tibiofemoral osteoarthritis (Kellgren-Lawrence grade 2-4)

You may not qualify if:

  • Worst knee pain score on day of evaluation \<4/10
  • Already taking opioids \>100 mg/day of morphine equivalent dose
  • Infectious etiology (over RFA insertion site or systemic)
  • Workers compensation
  • History of adverse reaction to local anesthetic or contrast
  • History of intraarticular injection in the last 6 weeks with steroids or hyaluronic acids
  • Prior total knee arthroplasty
  • Prior open knee surgery or ligament reconstruction
  • Prior RFA of knee joint
  • Connective tissue diseases affecting the knee
  • Sciatic pain
  • Pacemaker
  • Pregnancy
  • Severe medical disease
  • Serious neurological disorders
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (17)

  • Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.

    PMID: 26488691BACKGROUND

  • Singh JA, Vessely MB, Harmsen WS, Schleck CD, Melton LJ 3rd, Kurland RL, Berry DJ. A population-based study of trends in the use of total hip and total knee arthroplasty, 1969-2008. Mayo Clin Proc. 2010 Oct;85(10):898-904. doi: 10.4065/mcp.2010.0115. Epub 2010 Sep 7.

    PMID: 20823375BACKGROUND

  • Lenguerrand E, Wylde V, Gooberman-Hill R, Sayers A, Brunton L, Beswick AD, Dieppe P, Blom AW. Trajectories of Pain and Function after Primary Hip and Knee Arthroplasty: The ADAPT Cohort Study. PLoS One. 2016 Feb 12;11(2):e0149306. doi: 10.1371/journal.pone.0149306. eCollection 2016.

    PMID: 26871909BACKGROUND

  • Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

    PMID: 17403800BACKGROUND

  • Singh JA, Lewallen DG. Are outcomes after total knee arthroplasty worsening over time? A time-trends study of activity limitation and pain outcomes. BMC Musculoskelet Disord. 2014 Dec 17;15:440. doi: 10.1186/1471-2474-15-440.

    PMID: 25519240BACKGROUND

  • Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.

    PMID: 22398175BACKGROUND

  • Wylde V, Dieppe P, Hewlett S, Learmonth ID. Total knee replacement: is it really an effective procedure for all? Knee. 2007 Dec;14(6):417-23. doi: 10.1016/j.knee.2007.06.001. Epub 2007 Jun 26.

    PMID: 17596949BACKGROUND

  • Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8.

    PMID: 24201900BACKGROUND

  • Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.

    PMID: 22357571BACKGROUND

  • Dunbar MJ, Richardson G, Robertsson O. I can't get no satisfaction after my total knee replacement: rhymes and reasons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):148-52. doi: 10.1302/0301-620X.95B11.32767.

    PMID: 24187375BACKGROUND

  • Wylde V, Hewlett S, Learmonth ID, Dieppe P. Persistent pain after joint replacement: prevalence, sensory qualities, and postoperative determinants. Pain. 2011 Mar;152(3):566-572. doi: 10.1016/j.pain.2010.11.023. Epub 2011 Jan 15.

    PMID: 21239114BACKGROUND

  • Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011 Apr;97(2):139-44. doi: 10.1016/j.otsr.2010.12.003. Epub 2011 Mar 8.

    PMID: 21388906BACKGROUND

  • Srikandarajah S, Gilron I. Systematic review of movement-evoked pain versus pain at rest in postsurgical clinical trials and meta-analyses: a fundamental distinction requiring standardized measurement. Pain. 2011 Aug;152(8):1734-1739. doi: 10.1016/j.pain.2011.02.008. Epub 2011 Mar 12.

    PMID: 21402445BACKGROUND

  • Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c.

    PMID: 20299989BACKGROUND

  • Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.

    PMID: 21055873BACKGROUND

  • Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.

    PMID: 21872812BACKGROUND

  • Mishra P, Edwards D, Huntoon M, Sobey C, Polkowski G, Corey J, Mishra KL, Shinar A, Engstrom S, Palmer C, Bruehl S. Is preoperative genicular radiofrequency ablation effective for reducing pain following total knee arthroplasty? A pilot randomized clinical trial. Reg Anesth Pain Med. 2021 Sep;46(9):752-756. doi: 10.1136/rapm-2021-102501. Epub 2021 Jul 2.

    PMID: 34215667DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Puneet Mishra, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology and Pain Medicine, BH Robbins Scholar

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 27, 2016

Study Start

January 26, 2018

Primary Completion

September 9, 2020

Study Completion

September 9, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)