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Genicular Radiofrequency Ablation Following Total Knee Arthroplasty (GRATKA)

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Genicular Radiofrequency Ablation
Sham Genicular Radiofrequency Ablation
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Genicular Radiofrequency Ablation, Randomized Controlled Trial, Knee Pain, Balance

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >1 year post TKA
  • persistent knee pain > 4/10 in intensity on average over the prior week of one of the post-TKA knees
  • refractory to conventional treatment (i.e., physiotherapy, medication, etc.)
  • ≥80% pain relief with a single fluoroscopically guided local anesthetic block using 0.5 mL of 2% lidocaine for the medial and lateral branches of the nerve to the vastus intermedialis, nerve to the vastus lateralis*, inferior medial genicular nerve, infrapatellar branch of the saphenous nerve, and the recurrent fibular nerve. 0.5 mL will be injected over 2 spots (1.5 cm apart) for each of the superior medial and lateral genicular nerves corresponding to the sites of the RF cannulae for the bipolar strip lesions. *Blocks will be combined fluoroscopy/ultrasound guided.

Exclusion Criteria:

  • Infection (peri-prosthetic, joint, systemic, skin/soft tissue overlying the knee to be treated)
  • Prosthetic loosening or failure, periprosthetic fracture
  • Severe psychiatric disorder
  • Non-genicular lower extremity pain source from the spine (i.e., radiculopathy or neurogenic claudication) or peripheral joints (i.e., hip osteoarthritis)
  • Peripheral vascular disease causing vascular claudication
  • Connective tissue/inflammatory joint disease/widespread soft tissue pain disorder
  • Poor tolerance of injection procedures (as observed from the prognostic local anesthetic blocks)
  • Allergy to local anesthetic, synovial expansion into the anticipated path(s) of the local anesthetic needle/RF cannula as determined by ultrasound scanning
  • Uncontrolled bleeding diathesis
  • Pregnancy
  • Pacemaker or neurostimulator
  • Inability to complete Patient-Reported Outcome Measures due to cognitive or language limitations.

Sites / Locations

  • Vivo Cura HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 (GRFA)

Group 2 (Sham)

Arm Description

After the cannulae are placed and tines deployed, a single lesion (30 second ramp-up time; 80C x 2 minutes) will be made at each of the medial and lateral branches of the nerve to the vastus intermedialis, nerves to the vastus lateralis and medialis, recurrent fibular nerve, inferior medial genicular nerve. One bipolar strip lesion (intercannula distance 1.5 cm; anticipated strip lesion length 2.0 cm) at the superior medial and lateral genicular nerves will be made to accommodate anatomical variability.

The same procedure will be employed as per Group 1 - However, the sham procedure will involve no electrical signal applied to the participant.

Outcomes

Primary Outcome Measures

Average Pain Intensity Over the Prior week (0 - 10)
Numerical pain rating scale (0 - 10) with higher scores indicating a worse outcome
Change in pain intensity between pre- and 6-months post-intervention
Numerical Pain rating scale (NPRS) 6 month minus NPRS pre-intervention, with increased negative scores indicating a better outcome
Proportion of participants exceeding 50% pain relief
Proportion of participants that experience ≥ 50% pain relief
Proportion of participants exceeding Minimal Clinically Important Difference (MCID) pain relief
Proportion of participants that experience MCID knee pain relief
Safety - Adverse Events
Presence of self-reported complications

Secondary Outcome Measures

Average Pain Intensity Over the Prior Week (0 - 10)
Numerical pain rating scale (0 - 10) with higher scores indicating worse outcomes
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measure of pain (0 - 20), stiffness (0 - 8) and physical function (0 - 68) with higher scores indicating wore pain, stiffness and functional limitations
The Clinical Global Impressions Scale (CGI)
Patient reported global impression of change (1 = Very Much Improved to 7 = Very Much Worse)
Perceived Need for Revision Arthroplasty
"If revision surgery of your knee replacement was available to you, how interested would you be in having it at this time?" Y or N
Analgesic Use
Quantitative Analgesic Questionnaire
Health-related Quality of Life
EQ-5D-5L

Full Information

First Posted
February 18, 2022
Last Updated
May 8, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT05283889
Brief Title
Genicular Radiofrequency Ablation Following Total Knee Arthroplasty
Acronym
GRATKA
Official Title
The Safety and Efficacy of Genicular Radiofrequency Ablation for Patients With Persistent Knee Pain Following Total Knee Arthroplasty - A Triple Blinded Randomized Sham-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Currently, nearly 1 million total knee arthroplasties (TKA) are performed yearly in the United States. Three million are projected to be performed in 2040. Between 15-30% of all patients who undergo TKA have continued pain, reduced quality of life and functional impairments that cannot be attributed to hardware failure/loosening or infection. Treatment options for persistent post TKA pain (failed TKA) are limited. There is a need for minimally invasive, and effective pain and disability modulating interventions for patients with failed TKA. Genicular radiofrequency ablation (GRFA) has been described, refined, and validated as an effective minimally invasive intervention to control refractory knee pain secondary to knee osteoarthritis (OA) as evidenced by three favorable meta-analyses published in 2021 alone.3-5 GRFA is a minimally invasive percutaneous procedure that utilizes thermal energy to coagulate nerves from the knee. Though sometimes used in practice, there is limited research describing and evaluating GRFA for patients with failed TKA. This will be the first trial to evaluate the safety and efficacy of GRFA in patients with failed TKA using a robust study design and up-to-date, evidence-based selection criteria and technique.
Detailed Description
The general objective of this study is to determine the safety and efficacy of GRFA in patients with failed TKA. The central hypothesis is that GRFA is safe and more efficacious in improving pain and function than sham GRFA. A triple blinded randomized sham-controlled trial design will be used. Patients with failed TKA will be recruited and randomized into either a thermal or sham GRFA group. Patient selection criteria and GRFA procedural technique will incorporate refinements based on expanded understanding from recent research. Outcomes will be assessed prior to and at 3, 6 and 12 months post-GRFA. The primary outcome measures will be change in pain (NRS). Secondary outcomes will include safety and changes in function (WOMAC; sit-stand test; strength; range of motion & balance), participants' impression of change, perceived need for revision arthroplasty, analgesic use, and quality-of-life. Crossover will be offered to participants in the sham group at 6 months post-treatment. Data will be analyzed using descriptive, linear mixed-effects model and Kaplan-Meier Survival Curve statistics. The proposed research is innovative and important as it uses a robust study design to evaluate the safety and efficacy of an emerging RFA intervention in a prevalent suffering patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Genicular Radiofrequency Ablation, Randomized Controlled Trial, Knee Pain, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Triple blinding will be accomplished as follows: operator (RF generator operated by assistant out of sight of operator); participant (local anesthetic administration and cannula placement identical; RF generator makes the same beeping sound for the same duration); assessor (only the study coordinator is aware of group assignment).
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (GRFA)
Arm Type
Experimental
Arm Description
After the cannulae are placed and tines deployed, a single lesion (30 second ramp-up time; 80C x 2 minutes) will be made at each of the medial and lateral branches of the nerve to the vastus intermedialis, nerves to the vastus lateralis and medialis, recurrent fibular nerve, inferior medial genicular nerve. One bipolar strip lesion (intercannula distance 1.5 cm; anticipated strip lesion length 2.0 cm) at the superior medial and lateral genicular nerves will be made to accommodate anatomical variability.
Arm Title
Group 2 (Sham)
Arm Type
Active Comparator
Arm Description
The same procedure will be employed as per Group 1 - However, the sham procedure will involve no electrical signal applied to the participant.
Intervention Type
Procedure
Intervention Name(s)
Genicular Radiofrequency Ablation
Intervention Description
After the cannulae are placed and tines deployed, a single lesion (30 second ramp-up time; 80C x 2 minutes) will be made at each of the medial and lateral branches of the nerve to the vastus intermedialis, nerves to the vastus lateralis and medialis, recurrent fibular nerve, inferior medial genicular nerve. One bipolar strip lesion (intercannula distance 1.5 cm; anticipated strip lesion length 2.0 cm) at the superior medial and lateral genicular nerves will be made to accommodate anatomical variability.
Intervention Type
Procedure
Intervention Name(s)
Sham Genicular Radiofrequency Ablation
Intervention Description
After the cannulae are placed and tines deployed, a single lesion (no electrical signal applied to patient) will be made at each of the medial and lateral branches of the nerve to the vastus intermedialis, nerves to the vastus lateralis and medialis, recurrent fibular nerve, inferior medial genicular nerve. One bipolar strip lesion (intercannula distance 1.5 cm; anticipated strip lesion length 2.0 cm) at the superior medial and lateral genicular nerves will be made to accommodate anatomical variability.
Primary Outcome Measure Information:
Title
Average Pain Intensity Over the Prior week (0 - 10)
Description
Numerical pain rating scale (0 - 10) with higher scores indicating a worse outcome
Time Frame
6 months
Title
Change in pain intensity between pre- and 6-months post-intervention
Description
Numerical Pain rating scale (NPRS) 6 month minus NPRS pre-intervention, with increased negative scores indicating a better outcome
Time Frame
6 months
Title
Proportion of participants exceeding 50% pain relief
Description
Proportion of participants that experience ≥ 50% pain relief
Time Frame
6 months
Title
Proportion of participants exceeding Minimal Clinically Important Difference (MCID) pain relief
Description
Proportion of participants that experience MCID knee pain relief
Time Frame
6 months
Title
Safety - Adverse Events
Description
Presence of self-reported complications
Time Frame
1-week, 3, 6 and 12-months post-intervention
Secondary Outcome Measure Information:
Title
Average Pain Intensity Over the Prior Week (0 - 10)
Description
Numerical pain rating scale (0 - 10) with higher scores indicating worse outcomes
Time Frame
3 and 12-months post-intervention
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
Measure of pain (0 - 20), stiffness (0 - 8) and physical function (0 - 68) with higher scores indicating wore pain, stiffness and functional limitations
Time Frame
3, 6 and 12-months post-intervention
Title
The Clinical Global Impressions Scale (CGI)
Description
Patient reported global impression of change (1 = Very Much Improved to 7 = Very Much Worse)
Time Frame
3, 6 and 12-months post-intervention
Title
Perceived Need for Revision Arthroplasty
Description
"If revision surgery of your knee replacement was available to you, how interested would you be in having it at this time?" Y or N
Time Frame
Baseline (Prior to), 3, 6 and 12-months post-intervention
Title
Analgesic Use
Description
Quantitative Analgesic Questionnaire
Time Frame
Baseline (Prior to), 3, 6 and 12-months post-intervention
Title
Health-related Quality of Life
Description
EQ-5D-5L
Time Frame
Baseline (Prior to), 3, 6 and 12-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >1 year post TKA persistent knee pain > 4/10 in intensity on average over the prior week of one of the post-TKA knees refractory to conventional treatment (i.e., physiotherapy, medication, etc.) ≥80% pain relief with a single fluoroscopically guided local anesthetic block using 0.5 mL of 2% lidocaine for the medial and lateral branches of the nerve to the vastus intermedialis, nerve to the vastus lateralis*, inferior medial genicular nerve, infrapatellar branch of the saphenous nerve, and the recurrent fibular nerve. 0.5 mL will be injected over 2 spots (1.5 cm apart) for each of the superior medial and lateral genicular nerves corresponding to the sites of the RF cannulae for the bipolar strip lesions. *Blocks will be combined fluoroscopy/ultrasound guided. Exclusion Criteria: Infection (peri-prosthetic, joint, systemic, skin/soft tissue overlying the knee to be treated) Prosthetic loosening or failure, periprosthetic fracture Severe psychiatric disorder Non-genicular lower extremity pain source from the spine (i.e., radiculopathy or neurogenic claudication) or peripheral joints (i.e., hip osteoarthritis) Peripheral vascular disease causing vascular claudication Connective tissue/inflammatory joint disease/widespread soft tissue pain disorder Poor tolerance of injection procedures (as observed from the prognostic local anesthetic blocks) Allergy to local anesthetic, synovial expansion into the anticipated path(s) of the local anesthetic needle/RF cannula as determined by ultrasound scanning Uncontrolled bleeding diathesis Pregnancy Pacemaker or neurostimulator Inability to complete Patient-Reported Outcome Measures due to cognitive or language limitations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Laxshimalla
Phone
4032653838
Email
jennifer.laxshimalla@vivocura.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Smith, PhD
Phone
4032653838
Email
ashley.smith3@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Smith, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vivo Cura Health
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2E2P5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Laxshimalla
Phone
4032653838
Email
jennifer.laxshimalla@vivocura.ca
First Name & Middle Initial & Last Name & Degree
Ashley Smith, PhD
Phone
4032653838
Email
ashley.smith3@ucalgary.ca

12. IPD Sharing Statement

Plan to Share IPD
No
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Genicular Radiofrequency Ablation Following Total Knee Arthroplasty

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