NCT02925442

Brief Summary

Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer minimally invasive, non-surgical, non-opioid pain relief options following surgery. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA, and control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

October 3, 2016

Last Update Submit

May 22, 2019

Conditions

Osteoarthritis of the Knee

Keywords

Unilateral Knee ArthroplastyRadiofrequency AblationGenicularRFAC-RFAt-RFAtotal knee replacement

Outcome Measures

Primary Outcomes (2)

  • Postoperative analgesic consumption

    Measure opioid consumption for the three study arms

    0 - 3 weeks postoperatively

  • Hospital Length of Stay (LOS)

    Measure hospital length of stay for the three study arms

    0-5 days postoperatively

Secondary Outcomes (1)

  • Pain Score

    before treatment arm procedures to 12 months after unilateral knee arthroplasty

Study Arms (3)

Standard Thermal radiofrequency ablation

EXPERIMENTAL

Patients randomized to t-RFA will receive standard genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management.

Procedure: t-RFA

Cooled radiofrequency ablation

EXPERIMENTAL

Patients randomized to C-RFA will receive cooled genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management.

Procedure: C-RFA

Control:Placebo Sham

SHAM COMPARATOR

Patients randomized to control will receive simulated genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty and receive the industry standard of care for unilateral knee arthroplasty pain management.

Procedure: Control

Interventions

t-RFAPROCEDURE

standard thermal genicular radiofrequency ablation

Also known as: Standard thermal genicular radiofrequency ablation
Standard Thermal radiofrequency ablation
C-RFAPROCEDURE

Cooled radiofrequency ablation

Also known as: Coolief radiofrequency ablation
Cooled radiofrequency ablation
ControlPROCEDURE

Simulated radiofrequency ablation for placebo controlled group

Also known as: Placebo Sham
Control:Placebo Sham

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritis of the knee where unilateral knee arthroplasty is indicated by radiograph, function decrease and/or pain indication and readiness to undergo t-RFA, C-RFA or sham treatment.

You may not qualify if:

  • □ • NO DAILY OPIOID CONSUMPTION 5 WEEKS PRIOR TO ENROLLMENT
  • NO DOCUMENTED NARCOTIC DEPENDENCY OR RECREATIONAL DRUG USE
  • NO TOBACCO USAGE WITHIN 2 MONTHS PRIOR TO SURGERY
  • NO CONFOUNDING INFLAMMATORY ARTHRITIS DISEASES ARE PRESENT
  • NO NEUROPATHY OR NEURO IMPAIRMENT PRESENT
  • NO SIGNIFICANT ACUTE ILLNESS OR INFECTION
  • NO OTHER CONFOUNDING CHRONIC PAIN
  • NO INVESTIGATIONAL AGENT WITHIN 3 MONTHS PRIOR TO ENROLLMENT
  • NO DIAGNOSED THROMBOPHILIA
  • NO SEVERE CARDIAC OR PULMONARY COMPROMISE
  • NO BLEEDING DISORDER(S)
  • NO ALLERGIC REACTION TO LOCAL ANESTHESIA, STEROIDS, OR IMPLANT MATERIALS
  • NO BREASTFEEDING
  • NO PREGNANCY
  • NO CONFOUNDING PSYCHIATRIC ILLNESSES
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orthopedic Specialty Institute

Coeur d'Alene, Idaho, 83814, United States

Location

Orthopedic Specialty Institute

Spokane, Washington, 99202, United States

Location

Related Publications (6)

  • Schiltenwolf M, Fischer C. Choi WJ et al. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain 2011; 152: 481-7. Pain. 2011 Aug;152(8):1933-1934. doi: 10.1016/j.pain.2011.05.031. Epub 2011 Jun 22. No abstract available.

    PMID: 21700390BACKGROUND

  • Husted H, Lunn TH, Troelsen A, Gaarn-Larsen L, Kristensen BB, Kehlet H. Why still in hospital after fast-track hip and knee arthroplasty? Acta Orthop. 2011 Dec;82(6):679-84. doi: 10.3109/17453674.2011.636682. Epub 2011 Nov 9.

    PMID: 22066560BACKGROUND

  • 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

  • Patel A, Pavlou G, Mujica-Mota RE, Toms AD. The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone Joint J. 2015 Aug;97-B(8):1076-81. doi: 10.1302/0301-620X.97B8.35170.

    PMID: 26224824BACKGROUND

  • Stelzer W, Aiglesberger M, Stelzer D, Stelzer V. Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series. Pain Med. 2013 Jan;14(1):29-35. doi: 10.1111/pme.12014. Epub 2012 Dec 28.

    PMID: 23279364BACKGROUND

  • Lyman JR, Olscamp AJ, Lovell TP, Winegar CD, Wilson AN. Radiofrequency ablation prior to total knee arthroplasty does not improve post-surgical pain or recovery: a double-blinded, multi-center, randomized clinical trial. Ann Jt. 2023 Jan 15;8:5. doi: 10.21037/aoj-22-33. eCollection 2023.

    PMID: 38529234DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jeffrey Lyman, MD

    Orthopedic Specialty Institute

    PRINCIPAL INVESTIGATOR

  • Timothy Lovell, MD

    Providence Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Genicular radiofrequency ablation performed prior to total knee arthroplasty for pain management
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 5, 2016

Study Start

January 25, 2017

Primary Completion

January 7, 2020

Study Completion

February 7, 2020

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

US(2)