Total Knee Arthroplasty in Conjunction With Intra-operative Genicular Nerve Radio-Frequency Ablation, A Randomized Controlled Clinical Trial
Phase: NA
Conditions: Post Operative Pain, Functional Outcome
Sponsor: Ain Shams University

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
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Protocol of a Thesis for partial fulfillment of 
M.D. degree of Orthopedic Surgery 
 
Title of the protocol: Total Knee Arthroplasty in conjunction with 
intra-operative Genicular Nerve Radio-Frequency Ablation,                    
A randomized controlled clinical trial 
 
Post graduate student: Assem Mohamed Mahmoud Ahmed  
Degree: Master degree of orthopedic surgery  
 
Director: Professor Amr Khairy Mahmoud 
Academic position: Professor  
Department: Orthopedic surgery  
 
Co-director: Professor Ibrahim Mostafa El Ganzoury 
Academic position: Professor 
Department: Orthopedic surgery  
 
 
Co-director: Professor Haytham Abdelazim Mohamed 
Academic position: Professor  
Department: Orthopedic surgery  
 
Co-director: Dr. Ahmed Mohamed Mohasseb 
Academic position: Assistant professor 
Department: Orthopedic surgery 
 
 
 
 
 
 
 
12-1-2022 
 

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
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What is already known about this subject?  
What does this study add? 
Total knee arthroplasty (TKA) is considered the gold standard 
management for advanced knee osteoarthritis, however around 20% of 
the patients still complain of persistent knee pain after the operation1. 
This study will add a new concept of combining genicular nerve radio-
frequency ablation (GNRFA) with TKA In a hypothesis to improve 
functional outcome, post-operative pain and quality of life. 
 
 
1.Introduction/Review  
Total knee arthroplasty is a very common operation, and its 
incidence is believed to increase furthermore in the near future2.Thats 
why there are a lot of studies focused on improving the patient’s 
satisfaction rate, while the unsatisfied patients remain to vary from 10%-
30% without any noticeable complications3.Early post operative 
rehabilitation and fast track protocols showed improvement in functional 
outcome and pain relief but are still hindered by the patients 
compliance4.The idea of implementing genicular nerve radio-frequency 
ablation in combination with TKA rose when GNRFA showed significant 
improvement in patients with chronic knee osteoarthritis, studies showed 
pain relief up to 67% at the first 3 months, yet alone it has a very slim 
indications as it addresses only the biological aspect of the knee 
osteoarthritis without resolving the mechanical problem that will continue 
to progress over time5.Other studies showed positive outcome of GNRFA 
in cases of chronic knee pain after TKA6 , 7. 
Given that data, combining GNRFA with TKA might give the patient a 
better chance to proceed with early rehabilitation programs improving the 
functional outcome, while decreasing postoperative pain is also 
considered an important factor of patients’ satisfaction and quality of life 
enhancement. 
 

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
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2.Aim/Objectives 
To compare between conventional Total Knee Arthroplasty (TKA) and Total 
Knee Arthroplasty (TKA) combined with intra-operative Genicular Nerve Radio-
Frequency Ablation (GNRFA), concerning post-operative functional outcome 
and pain scores in patients with advanced knee osteoarthritis.  
 
3.Methodology 
• Type of the study: Randomized controlled clinical trial  
• Study setting: Ain Shams University hospitals 
• Study period: 24 months 
• Study population: Patients with advanced knee osteoarthritis   
Inclusion criteria: 
o Both sexes  
o Age from 50-80 years old  
    Exclusion criteria: 
o Patients unfit for surgery 
o Patients underwent previous GNRFA 
• Sampling method: Convenient sample 
• Sample size: 70 knees will be randomly divided by a computer-generated 
sequence in to 2 groups: 
o Group A (≈35 knees): will undergo TKA  
o Group B (≈35 knees): will undergo TKA combined with GNRFA 
• Ethical considerations: will be followed by obtaining the hospital 
research/ethics committee approval and written informed consents from 
the patients. 

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
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• Study tools: 
o Preoperative diagnosis and evaluation: 
➢ Clinical Evaluation: 
▪ History 
▪ General examination 
▪ Local examination (pre-operative) 
➢ Radiological Evaluation:  
▪ Plain X-ray antero-posterior standing view of the 
diseased knee. 
▪ Plain X-ray lateral view of the diseased knee. 
➢ Laboratory investigations:  
▪ Routine preoperative lab investigations 
o Operative technique:  
Patients will be operated using standard mid-vastus approach, 
conventional GNRFA 
o Post-operative management:  
▪ Proper antibiotic and standardized analgesics protocol will 
be given post-operative  
▪ Prophylaxis against DVT  
▪ Post-operative x-rays will be done, Plain X-ray antero-
posterior and lateral view of the operated knee. 
 
 

                                                                                                                            
 
MDThesis/MFA/ISRO/FacultyofMedicine/ASU 
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o Follow up strategy: 
Patients will be reviewed after 2 weeks to check their 
wounds and for sutures removal, then the follow up will be 
every month in the first 6 months then every 3 months till 
the end of the study (2 years). The follow up will include: 
➢ Clinical and functional assessment:  
▪ Oxford knee score to assess the function. 
▪ Visual analogue scale (VAS) to assess pain. 
▪ Emotional acceptance/ Patient satisfaction. 
➢ Radiological assessment: 
Plain X-ray as described before at every follow up visit. 
• Statistical Analysis: Statistical package for social science (SPSS 15.0.1 for 
windows; SPSS Inc., Chicago, IL, 2001).  Data will be presented as Mean 
and Standard deviation (+/-SD) for quantitative parametric data, and 
Median and Interquartile range for quantitative non-parametric data. 
Frequency and percentage will be used for presenting qualitative data. 
Suitable analysis will be done according to the type of data obtained. 
P<0.05 will be considered significant. 
• Statistical package: data entry and statistical analysis of the collected 
data will be performed using a reliable software program. 
 
 
 
 
 

                                                                                                                            
 
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4.References  
1.  
Malik AT, Khan S, Ali A, Mufarrih SH, Noordin S. Total knee arthroplasty: 
does day of surgery matter? Clinical Medicine Insights: Arthritis and 
Musculoskeletal Disorders. 2018;11:1179544117754067. 
2.  
Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected 
increase in total knee arthroplasty in the United States–an alternative 
projection model. Osteoarthritis and cartilage. 2017;25(11):1797-1803. 
3.  
Kim SJ, Bamne A, Song YD, Kang YG, Kim TK. Patients still wish for key 
improvements after total knee arthroplasty. Knee surgery & related 
research. 2015;27(1):24. 
4.  
Vavro M, Ziakova E, Gazdikova K, Farkasova D. Does standard post-
operative rehabilitation have its place after total knee replacement? 
Bratislavske lekarske listy. 2016;117(10):605-608. 
5.  
Ferdinand Iannaccone D, Samuel Dixon R, Andrew Kaufman M. A review of 
long-term pain relief after genicular nerve radiofrequency ablation in 
chronic knee osteoarthritis. Pain physician. 2017;20:E437-E444. 
6.  
Leong JF, Rani RA, bin Anuar MS, Ariff MAM, Hamdan N, Yahaya M. An 
Alternative Way to Relieve Neuropathic Pain After Total Knee 
Replacement by Genicular Nerve Radio-Frequency Ablation. 
7.  
Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of 
radiofrequency treatment for chronic knee pain after total knee 
arthroplasty. PM&R. 2014;6(4):373-376.