Osteoarthritis of KneeNCT06651762
Ultra Sound Guided Genicular Nerves Cooled Radiofrequency Ablation in Total Knee Replacement Surgeries
A study testing unilateral Radiofrequency, bilateral Radiofrequency and Epidural in people with Osteoarthritis of Knee, run by Ain Shams University at 1 site in Egypt.
Trial summary
Total Knee Replacement surgery is common procedure that is usually done for patients suffering from persistent pain with limitation of movement. Unfortunately, they do suffer after the operation as it is associated still with significant pain that affect the rehabilitation plan, hospital length of stay, life style and… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- unilateral Radiofrequency, bilateral Radiofrequency and Epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Oct 2024to 25 Jan 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- • Allergy to any of the drugs used in the study
- Alcohol or drug abuse
- Psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Total Knee Replacement surgery is common procedure that is usually done for patients suffering from persistent pain with limitation of movement. Unfortunately, they do suffer after the operation as it is associated still with significant pain that affect the rehabilitation plan, hospital length of stay, life style and patient satisfaction. New approaches are rising every day to add to the multimodal management plan. Genicular nerves cooled radiofrequency ablation is a new approach that can be simply done U.S. guided with little side effects, if any, and great results.
Read the detailed description
the study measures the efficacy of genicular nerves cooled radiofrequency ablation in enhancing quality of rehabilitation in patients undergoing total knee replacement
- Conditions
- Osteoarthritis of Knee
- Being tested
- unilateral Radiofrequency, bilateral Radiofrequency, Epidural
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral RadiofrequencyProcedure or surgery
unilateral genicular nerve cooled radio frequency ablation pre-operative
bilateral RadiofrequencyProcedure or surgery
bilateral genicular nerve cooled radio frequency ablation pre-operative
EpiduralProcedure or surgery
Patients will receive epidural anesthesia intra operative and epidural analgesia post-operative
| Study group | Role | What they receive |
|---|---|---|
| lumber epidural anesthesia | Experimental | Patients will receive epidural anesthesia intra operative Receives: Procedure: Epidural |
| lumber Epidural and unilateral genicular nerve ablation: | Experimental | Patient will receive lumber epidural anesthesia and unilateral genicular nerve cooled radio frequency ablation pre-operative Receives: Procedure: unilateral Radiofrequency; Procedure: Epidural |
| Epidural and bilateral genicular nerve ablation | Experimental | Patient will receive lumber epidural anesthesia and bilateral genicular nerve cooled radio frequency ablation pre-operative Receives: Procedure: bilateral Radiofrequency; Procedure: Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
o Epidural rescue doses
rescue doses reflects degree of pain control
Measured: 1st 48 hours
Secondary outcomes (3)
WOMAC score
assessment of the functional state of the patient and degree of pain and limitation of movement
Measured: baseline preoperative, and the at 2, 6 and 12 weeks postoperative
Knee range of motion
Time to achieve full knee range of motion will be assessed by measuring active knee flexion and extension in degrees (°) using a universal goniometer during weekly postoperative assessments. The outcome will be reported as the number of days or weeks required to achieve full range of motion, as defined in the study protocol.
Measured: Assessed weekly for 3 weeks postoperatively (Weeks 1, 2, and 3)
Postoperative inflammatory signs assessed by clinical examination
Postoperative inflammatory signs, including redness (erythema), local warmth, and swelling around the operated knee, will be assessed by clinical examination. Each sign will be recorded as present or absent. The outcome will be reported as the number of participants with each inflammatory sign at each assessment.
Measured: Assessed weekly for 3 weeks postoperatively (Weeks 1, 2, and 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start14 Oct 2024
- Primary completion13 Aug 2025
- Study completion25 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651762
- Sponsor's protocol ID
- FMASU R221/2024
- Status last verified
- Sep 2024
- First submitted
- 19 Oct 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data required for interpretation of results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Sound Guided Genicular Nerves Cooled Radiofrequency Ablation in Total Knee Replacement Surgeries
- ClinicalTrials.gov ID
- NCT06651762
- Acronym / sponsor ID
- FMASU R221/2024
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 22 Oct 2024 (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.
Total Knee Replacement surgery is common procedure that is usually done for patients suffering from persistent pain with limitation of movement. Unfortunately, they do suffer after the operation as it is associated still with significant pain that affect the rehabilitation plan, hospital length of stay, life style and patient satisfaction. New approaches are rising every day to add to the multimodal management plan. Genicular nerves cooled radiofrequency ablation is a new approach that can be simply done U.S. guided with little side effects, if any, and great results.
Detailed description
the study measures the efficacy of genicular nerves cooled radiofrequency ablation in enhancing quality of rehabilitation in patients undergoing total knee replacement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lumber epidural anesthesia | Experimental | Procedure: EpiduralPatients will receive epidural anesthesia intra operative |
| lumber Epidural and unilateral genicular nerve ablation: | Experimental | Procedure: unilateral Radiofrequency, Procedure: EpiduralPatient will receive lumber epidural anesthesia and unilateral genicular nerve cooled radio frequency ablation pre-operative |
| Epidural and bilateral genicular nerve ablation | Experimental | Procedure: bilateral Radiofrequency, Procedure: EpiduralPatient will receive lumber epidural anesthesia and bilateral genicular nerve cooled radio frequency ablation pre-operative |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- • Allergy to any of the drugs used in the study
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 |
|---|---|---|
| unilateral Radiofrequencyunilateral genicular nerve cooled radio frequency ablation pre-operative | Procedure or surgery | lumber Epidural and unilateral genicular nerve ablation: |
| bilateral Radiofrequencybilateral genicular nerve cooled radio frequency ablation pre-operative | Procedure or surgery | Epidural and bilateral genicular nerve ablation |
| EpiduralPatients will receive epidural anesthesia intra operative and epidural analgesia post-operative | Procedure or surgery | Epidural and bilateral genicular nerve ablation, lumber Epidural and unilateral genicular nerve ablation:, lumber epidural anesthesia |
Primary outcome
o Epidural rescue doses
Time frame: 1st 48 hours
rescue doses reflects degree of pain control
3 secondary outcomes
WOMAC score
Time frame: baseline preoperative, and the at 2, 6 and 12 weeks postoperative
Knee range of motion
Time frame: Assessed weekly for 3 weeks postoperatively (Weeks 1, 2, and 3)
Postoperative inflammatory signs assessed by clinical examination
Time frame: Assessed weekly for 3 weeks postoperatively (Weeks 1, 2, and 3).
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 5 Aug 2026.
- Individual participant dataSharing planned: Yes. Data required for interpretation of results will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral Radiofrequency, bilateral Radiofrequency and Epidural in people with Osteoarthritis of Knee, 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 0 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 5 Aug 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?
o Epidural rescue doses (time frame: 1st 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.