NCT02931435

Brief Summary

Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty. The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

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 5, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

October 5, 2016

Last Update Submit

December 11, 2018

Conditions

Chronic Knee PainOsteoarthritis, Knee

Keywords

Genicular Radiofrequency AblationKnee Arthroplasty, Total

Outcome Measures

Primary Outcomes (1)

  • Mean difference in knee pain intensities as indicated on the Visual Analog Scale

    Baseline and 6 weeks post-radiofrequency ablation

Secondary Outcomes (7)

  • Change in Visual Analog Score of average knee pain

    Baseline to 1 week, 6 weeks, and 12 weeks

  • Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Baseline to 1 week, 6 weeks, and 12 weeks

  • Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Baseline to 1 week, 6 weeks, and 12 weeks

  • Change of Patient Global Assessment

    Baseline to 1 week, 6 weeks, and 12 weeks

  • Satisfaction with Radiofrequency Procedure

    Baseline to 1 week, 6 weeks, and 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Nerve Block with Radiofrequency Ablation

ACTIVE COMPARATOR

A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator activation.

Procedure: Nerve Block with Radiofrequency Ablation

Nerve Block with Sham Radiofrequency Ablation

SHAM COMPARATOR

A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance.Control patients will undergo the same procedure without RF generator activation. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator sham activation.

Procedure: Nerve Block with Sham Radiofrequency Ablation

Interventions

Nerve Block with Radiofrequency AblationPROCEDURE

Ablation of the genicular nerves of the knee by radiofrequency

Nerve Block with Radiofrequency Ablation
Nerve Block with Sham Radiofrequency AblationPROCEDURE

Genicular radiofrequency of the knee without neurotomy

Nerve Block with Sham Radiofrequency Ablation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study candidate must provide written informed consent.
  • Must be ≥ 50 years of age at the time of consent
  • Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent
  • Orthopedic evaluation indicating no further surgery is warranted
  • Stable pain medication regimen for 30 days prior to baseline visit
  • Knee pain is primary pain complaint

You may not qualify if:

  • Acute knee pain
  • Connective tissue disorders affecting the knee
  • Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator
  • Steroid or hyaluronic acid injections into the affected knee in the past 3 months
  • Confounding pain conditions of the index leg that may affect medication requirements or study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WK River Cities Clinical Research Center

Shreveport, Louisiana, 71105, United States

Location

Related Publications (4)

  • 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

  • Nikolaou VS, Chytas D, Babis GC. Common controversies in total knee replacement surgery: Current evidence. World J Orthop. 2014 Sep 18;5(4):460-8. doi: 10.5312/wjo.v5.i4.460. eCollection 2014 Sep 18.

    PMID: 25232522BACKGROUND

  • 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

  • Al-Hadithy N, Rozati H, Sewell MD, Dodds AL, Brooks P, Chatoo M. Causes of a painful total knee arthroplasty. Are patients still receiving total knee arthroplasty for extrinsic pathologies? Int Orthop. 2012 Jun;36(6):1185-9. doi: 10.1007/s00264-011-1473-6. Epub 2012 Jan 11.

    PMID: 22234706BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Nerve BlockRadiofrequency Ablation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeRadiofrequency TherapyTherapeuticsAblation Techniques

Study Officials

  • Randall Brewer, MD

    WK River Cities Clinical Research Center

    PRINCIPAL INVESTIGATOR

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
SPONSOR INVESTIGATOR
PI Title
Medical Director, Principal Investigator

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 13, 2016

Study Start

December 1, 2016

Primary Completion

November 20, 2018

Study Completion

November 30, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations

US(1)