The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty

In our study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA(Total Knee Arthroplasty) using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Knee Pain Chronic
• Intervention / Treatment: Procedure: Genicular nerve Radiofrequency Ablation block

Detailed Description

One of the most important components of surgery using Fast-Track is the application of effective and well-monitored pain treatment. Post-surgical pain negatively affects the patient's early mobilization. Reduction in pain after TKA(Total Knee Arthroplasty) may not only increase short-term functional results but also increase the patient's overall satisfaction.

Genicular Nerve Radiofrequency Ablation (GNRFA) is a non-surgical treatment increasingly used in patients with advanced knee osteoarthritis. Previous studies have shown this to be an effective and safe method to reduce pain and improve functionality in this patient population.

Neurolysis of genicular nerves with radiofrequency (RF) may be useful to relieve pain and improve both function and quality of life in patients with post-TKA pain.

Investigators thought that reducing the pain of patients who underwent TKA with Fast-track in the postoperative period would contribute to early mobilization and therefore rapid functional recovery. As a result of previous studies, investigators know that genicular nerve neurolysis with RF Ablation in the preoperative period provides a reduction in postoperative pain.

Investigators routinely apply TKA applications in clinic with Fast-Track. In investigators hospital's algology outpatient clinic, genicular nerve RF ablation is routinely performed under USG or fluoroscopy guidance. In investigators study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: HARUN R GUNGOR, MD; Phone Number: +90 258-296-5690; Email: hrgungor@gmail.com
• Study Contact Backup: Name: MURAT I KIRBAS, MD; Phone Number: +90 506-783-0083; Email: mibrahimkirbas@gmail.com

Study Locations

• Turkey
  • Pamukkale
    • Denizli, Pamukkale, Turkey, 20100
      • Recruiting
      • Pamukkale University
      • Contact: MURAT I KIRBAS, MD; Phone Number: +90 506-783-0083; Email: mibrahimkirbas@gmail.com
      • Contact: Harun Reşit Güngör; Phone Number: +90 532-234-3770; Email: hrgungor@gmail.com
      • Principal Investigator: Murat İbrahim Kırbaş, MD
      • Sub-Investigator: Seher İlhan, Ass. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inclusion Criteria:

• Being between the ages of 40 and 85,
• Being able to understand verbal and written information given in Turkish,
• Being able to speak and understand Turkish,
• Being subjected to unilateral TKA surgery due to the diagnosis of Primary Knee osteoarthritis

Description

Inclusion Criteria:

• Being between the ages of 40 and 85,
• Being able to understand verbal and written information given in Turkish,
• Being able to speak and understand Turkish,
• Being subjected to unilateral TKA surgery due to the diagnosis of Primary Knee osteoarthritis

Exclusion Criteria:

• Patients planned for revision knee prosthesis surgery,
• Patients previously diagnosed with psychiatric disorders,
• Patients who have undergone major surgery on the extremity where TKA will be applied,
• Patients with comorbid diseases such as rheumatoid arthritis or cancer,
• Patients with a score above 3 according to the American Society of Anesthesiologists (ASA) scoring,
• Patients with neurological diseases that cause functional disability,
• Patients with flexion limitation of more than 45 degrees and extension limitation of more than 20 degrees,
• Patients who have to use hypnotic or anxiolytic drugs regularly,
• Patients with alcohol or drug addiction,
• Patients with bleeding disorders
• Patients with uncontrolled diabetes

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TKA with radiofrequency ablation genicular nerve block	Procedure: Genicular nerve Radiofrequency Ablation block; Genicular nerve Radiofrequency Ablation block
TKA without nerve block; TKA without radiofrequency ablation genicular nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain preoperative	Visual Analog Scale used to assess pain	Baseline (preoperatively)
Pain postoperative 2	Visual Analog Scale used to assess pain	at postoperative twelfth weeks
Patient-reported activity limitations preoperative	The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used	Baseline (preoperatively)
Performance-based activity limitations-preoperative	30-sec chair-stand test and stair-climb test are used	Baseline (preoperatively)
Quality of life-preoperative	Short Form-36 (SF-36) is used	Baseline (preoperatively)
Length of hospital stay	Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours)	through study completion, an average of 1 year
Pain postoperative 1	Visual Analog Scale used to assess pain	at postoperative sixth weeks
Knee Range of Motion preoperative	Digital goniometer used to assess knee range of motion	Baseline (preoperatively)
Knee Range of Motion postoperative 1	Digital goniometer used to assess knee range of motion	at postoperative sixth week
Knee Range of Motion postoperative 2	Digital goniometer used to assess knee range of motion	at postoperative twelfth week
Quadriceps muscle strength preoperative	Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer	Baseline (preoperatively)
Quadriceps muscle strength postoperative 1	Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer	at postoperative sixth weeks
Quadriceps muscle strength postoperative 2	Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer	at postoperative twelfth week
Patient-reported activity limitations preoperative 1	The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used	at postoperative sixth weeks
Patient-reported activity limitations preoperative 2	The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used	at postoperative twelfth week
Performance-based activity limitations-preoperative 1	30-sec chair-stand test and stair-climb test are used	at postoperative sixth weeks
Performance-based activity limitations-preoperative 2	30-sec chair-stand test and stair-climb test are used	at postoperative twelfth week
Quality of life-preoperative 1	Short Form-36 (SF-36) is used	at postoperative sixth weeks
Quality of life-preoperative 2	Short Form-36 (SF-36) is used	at postoperative twelfth week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of operation time	Length of operation time is measured in minutes during the surgery	the surgery
Amount of blood loss	Amount of blood loss is measured from the suction drainage (unit-milliliters)	through study completion, an average of 1 year
postoperative component alignments	Long leg radiographs of the patients are evaluated postoperatively by using a digital orthopedic templating software-Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Pamukkale University

Publications and helpful links

General Publications

• Stake S, Agarwal AR, Coombs S, Cohen JS, Golladay GJ, Campbell JC, Thakkar SC. Total Knee Arthroplasty After Genicular Nerve Radiofrequency Ablation: Reduction in Prolonged Opioid Use Without Increased Postsurgical Complications. J Am Acad Orthop Surg Glob Res Rev. 2022 Aug 12;6(8):e22.00125. doi: 10.5435/JAAOSGlobal-D-22-00125. eCollection 2022 Aug 1.
• Lloyd JM, Wainwright T, Middleton RG. What is the role of minimally invasive surgery in a fast track hip and knee replacement pathway? Ann R Coll Surg Engl. 2012 Apr;94(3):148-51. doi: 10.1308/003588412X13171221590214.
• Sullivan M, Tanzer M, Reardon G, Amirault D, Dunbar M, Stanish W. The role of presurgical expectancies in predicting pain and function one year following total knee arthroplasty. Pain. 2011 Oct;152(10):2287-2293. doi: 10.1016/j.pain.2011.06.014. Epub 2011 Jul 18.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Estimated): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; Genicular Nerve Block; Fast-Track Total Knee Arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2023PAUOrto

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No