Post Operative PainNCT07381062
Total Knee Arthroplasty in Conjunction With Intra-operative Genicular Nerve Radio-Frequency Ablation
A study testing Total knee arthroplasty and Genicular nerve radiofrequency ablation in people with Post Operative Pain and Functional Outcome, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is 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 Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Post Operative Pain, Functional Outcome
- What is being tested?
- Total knee arthroplasty and Genicular nerve radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced knee osteoarthritis
- Both sexes
- Age from 50-80 years old
Who cannot join
- Patients underwent previous GNRFA
- Patients underwent previous knee surgery
- patients requiring constrained knee arthroplasty prosthesis (with extreme deformities)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Knee Arthroplasty in Conjunction With Intra-operative Genicular Nerve Radio-Frequency Ablation, A Randomized Controlled Clinical Trial
The aim of this study is 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
Read the detailed description
The aim of this study is 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
Including 70 knees randomized using a computer-generated sequence into two groups, the first group underwent TKA combined with GNRFA, and the other group underwent TKA only. All the TKA surgeries were performed by a single surgeon including patients aged from fifty to eighty years with advanced primary knee osteoarthritis from both sexes
- Conditions
- Post Operative Pain, Functional Outcome
- Being tested
- Total knee arthroplasty, Genicular nerve radiofrequency ablation
- Keywords
- Radio-Frequency Ablation, Total Knee Arthroplasty, Genicular nerve, Total knee arthroplasty functional outcome
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Also called knee joint replacement
Conventional Total knee arthroplasty operation performed
Genicular nerve radiofrequency ablationProcedure or surgery
Genicular nerve radiofrequency ablation done with no modifications except being performed with total knee arthroplasty in the same setting
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | underwent Total knee arthroplasty only Receives: Procedure: Total knee arthroplasty |
| Genicular nerve radio-frequency ablation | Experimental | underwent Total knee arthroplasty with genicular nerve radio-frequency ablation Receives: Procedure: Total knee arthroplasty; Procedure: Genicular nerve radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
pain assessment using Visual analogue scale, minimum value is 0 meaning no pain and maximum value is 10 meaning the worst pain, higher score means worse outcome
Measured: 6 months post operative
Post operative knee functional outcome
measuring the knee functional outcome post operative using oxford knee score, minimum score is 0 meaning the worse outcome and maximum is 48 meaning the best outcome. higher score means better outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start22 Feb 2022
- Primary completion4 Mar 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Assem Mohamed Mahmoud Ahmed, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381062
- Sponsor's protocol ID
- FMASU MD39/2022
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No need to contact them
Publications
Ahmed AMM, Kotb AS, Khairy A, El Ganzoury I, Abdelazim H, Mohasseb AM. Is genicular nerve radio frequency ablation the key to improving patients' satisfaction after total knee arthroplasty? a randomised controlled trial. J Orthop Surg Res. 2026 Apr 25;21(1):289. doi: 10.1186/s13018-026-06855-8.
PubMed 42035153
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty in Conjunction With Intra-operative Genicular Nerve Radio-Frequency Ablation, A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07381062
- Acronym / sponsor ID
- FMASU MD39/2022
- Conditions
- Post Operative Pain, Functional Outcome
- Keywords
- Radio-Frequency Ablation, Total Knee Arthroplasty, Genicular nerve, Total knee arthroplasty functional outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is 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
Detailed description
The aim of this study is 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
Including 70 knees randomized using a computer-generated sequence into two groups, the first group underwent TKA combined with GNRFA, and the other group underwent TKA only. All the TKA surgeries were performed by a single surgeon including patients aged from fifty to eighty years with advanced primary knee osteoarthritis from both sexes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Total knee arthroplastyunderwent Total knee arthroplasty only |
| Genicular nerve radio-frequency ablation | Experimental | Procedure: Total knee arthroplasty, Procedure: Genicular nerve radiofrequency ablationunderwent Total knee arthroplasty with genicular nerve radio-frequency ablation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with advanced knee osteoarthritis
- Both sexes
- Age from 50-80 years old
Key exclusion criteria (3 listed)
- Patients underwent previous GNRFA
- Patients underwent previous knee surgery
- patients requiring constrained knee arthroplasty prosthesis (with extreme deformities)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplastyAlso: knee joint replacementConventional Total knee arthroplasty operation performed | Procedure or surgery | Control, Genicular nerve radio-frequency ablation |
| Genicular nerve radiofrequency ablationGenicular nerve radiofrequency ablation done with no modifications except being performed with total knee arthroplasty in the same setting | Procedure or surgery | Genicular nerve radio-frequency ablation |
Primary outcome
Post operative pain
Time frame: 6 months post operative
pain assessment using Visual analogue scale, minimum value is 0 meaning no pain and maximum value is 10 meaning the worst pain, higher score means worse outcome
Post operative knee functional outcome
Time frame: 6 months
measuring the knee functional outcome post operative using oxford knee score, minimum score is 0 meaning the worse outcome and maximum is 48 meaning the best outcome. higher score means better outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Derived from this study: PubMed 42035153Ahmed AMM, Kotb AS, Khairy A, El Ganzoury I, Abdelazim H, Mohasseb AM. Is genicular nerve radio frequency ablation the key to improving patients' satisfaction after total knee arthroplasty? a randomised controlled trial. J Orthop Surg Res. 2026 Apr 25;21(1):289. doi: 10.1186/s13018-026-06855-8.
- Individual participant dataSharing planned: Undecided. No need to contact them
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assem Mohamed Mahmoud Ahmed, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty and Genicular nerve radiofrequency ablation in people with Post Operative Pain and Functional Outcome, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 6 months post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07381062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.