The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty
1 other identifier
observational
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2023
CompletedFirst Submitted
Initial submission to the registry
December 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJune 4, 2025
June 1, 2025
7 months
December 27, 2023
June 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
Pain preoperative
Visual Analog Scale used to assess pain
Baseline (preoperatively)
Pain postoperative 1
Visual Analog Scale used to assess pain
at postoperative sixth weeks
Pain postoperative 2
Visual Analog Scale used to assess pain
at postoperative twelfth 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
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Baseline (preoperatively)
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
30-sec chair-stand test and stair-climb test are used
Baseline (preoperatively)
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
Short Form-36 (SF-36) is used
Baseline (preoperatively)
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
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
Secondary Outcomes (3)
Length of operation time
the surgery
Amount of blood loss
through study completion, an average of 1 year
postoperative component alignments
through study completion, an average of 1 year
Study Arms (2)
TKA with radiofrequency ablation genicular nerve block
TKA with radiofrequency ablation genicular nerve block
TKA without nerve block
TKA without radiofrequency ablation genicular nerve block
Interventions
Genicular nerve Radiofrequency Ablation block
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University
Denizli, Pamukkale, 20100, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 35960987BACKGROUNDLloyd 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.
PMID: 22507716BACKGROUNDSullivan 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.
PMID: 21764515BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr
Study Record Dates
First Submitted
December 27, 2023
First Posted
February 2, 2024
Study Start
October 19, 2023
Primary Completion
May 30, 2024
Study Completion
June 1, 2025
Last Updated
June 4, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share