Osteoarthritis, KneeNCT06514703
Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis
A study testing CT-Guided Genicular Nerve Ablation and Fluoroscopic-Guided Genicular Nerve Ablation in people with Osteoarthritis, Knee, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of this study is to evaluate the comparative effectiveness of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain and improving function in adults diagnosed with knee osteoarthritis refractory to conservative treatment. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- CT-Guided Genicular Nerve Ablation and Fluoroscopic-Guided Genicular Nerve Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Sep 2024to 30 Dec 2025
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 45 to 80 years.
- Diagnosed with knee osteoarthritis.
- Knee osteoarthritis refractory to conservative treatment.
- Able to provide informed consent.
- Agree to follow the study procedures and attend follow-up visits.
Who cannot join
- Prior knee surgery within the last six months.
- Contraindications to genicular nerve ablation (e.g., certain types of infections, bleeding disorders).
- Severe comorbid conditions that may interfere with the study outcomes (e.g., rheumatoid arthritis, other severe autoimmune diseases).
- Current participation in another clinical trial that could interfere with the outcomes of this study.
- Allergy or sensitivity to the materials used in the ablation procedures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University, Faculty of Medicine
Zagazig, Sharqia Province, 44519
About this study
The goal of this study is to evaluate the comparative effectiveness of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain and improving function in adults diagnosed with knee osteoarthritis refractory to conservative treatment.
The main questions it aims to answer are:
Read more
- Does CT-guided genicular nerve ablation provide superior pain relief compared to fluoroscopic-guided genicular nerve ablation?
- Is there a significant difference in functional improvement between the two techniques?
Researchers will compare the outcomes between the CT-guided and fluoroscopic-guided groups to determine which method achieves better pain relief, functional enhancement, safety profile, and patient satisfaction.
Participants will:
- Undergo either CT-guided or fluoroscopic-guided genicular nerve ablation.
- Attend scheduled follow-up visits to assess pain levels, knee function, and any adverse events.
- Complete standardized questionnaires to provide feedback on pain relief, functional improvement, and overall satisfaction with the procedure.
Read the detailed description
Background:
Knee osteoarthritis is a chronic degenerative joint disease affecting millions worldwide, characterized by progressive cartilage loss, inflammation, and pain. Despite various treatment options such as intra-articular corticosteroids, viscosupplementation, and PRP injections, many patients experience inadequate relief or adverse effects. Genicular nerve ablation has emerged as a promising minimally invasive technique to alleviate chronic knee pain by interrupting pain transmission from the genicular nerves to the central nervous system.
Rationale:
The rationale for comparing CT-guided and fluoroscopic-guided genicular nerve ablation lies in optimizing treatment outcomes while ensuring patient safety and satisfaction. CT-guided procedures offer unparalleled precision in nerve localization, potentially enhancing the accuracy of nerve ablation and improving clinical outcomes. However, this method involves higher radiation exposure compared to fluoroscopic guidance, which utilizes real-time imaging with lower radiation doses. Understanding which approach provides superior pain relief, functional improvement, and patient satisfaction is crucial for optimizing treatment protocols and guiding clinical practice.
Objectives:
Primary Objective:
- Evaluate the efficacy of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain, as measured by the visual analog scale (VAS), at 3 months post-procedure.
Secondary Objectives:
- Evaluate changes in knee function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a validated scoring system specifically designed for osteoarthritis.
- Monitor and document any procedure-related adverse events to compare the safety profiles of both techniques.
- Evaluate patient satisfaction using the structured Patient Satisfaction Questionnaire (PSQ)
Study Design:
This study is a randomized controlled trial (RCT) aimed at evaluating the comparative effectiveness of CT-guided versus fluoroscopic-guided genicular nerve ablation. Eligible patients will be randomly allocated to one of the two treatment groups. Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments.
Participants:
- Inclusion Criteria: Adults aged 45-80 diagnosed with knee osteoarthritis refractory to conservative treatment, characterized by persistent knee pain despite medication and physical therapy.
- Exclusion Criteria: Patients with contraindications to genicular nerve ablation procedures (e.g., allergy to local anesthetics, active infection at the procedure site), or recent knee surgery within the last six months.
Interventions:
- CT-guided Genicular Nerve Ablation: Patients will undergo CT-guided genicular nerve ablation, involving meticulous planning of needle placement under CT imaging to accurately target the genicular nerves responsible for knee pain. Ablation parameters will be standardized to ensure consistency across procedures.
- Fluoroscopic-guided Genicular Nerve Ablation: Patients assigned to this group will undergo genicular nerve ablation under fluoroscopic guidance, utilizing real-time X-ray imaging to guide needle placement and confirm adequate nerve coverage before ablation.
Outcomes:
- Primary Outcome: Reduction in knee pain measured by visual analog scale (VAS) at 3 months post-procedure.
- Secondary Outcomes
- Improvement in knee function measured by changes in WOMAC scores over the follow-up period.
- Incidence and nature of any procedure-related adverse events
- Patient-reported outcomes regarding satisfaction, using the structured PSQ
Follow-Up:
Participants will be closely monitored post-procedure with scheduled follow-up visits at 1 week, 1 month, 3 months, and 6 months. These visits will include clinical assessments, pain evaluations, functional tests, and documentation of any adverse events.
Conclusion:
This study aims to provide valuable insights into the comparative effectiveness, safety, and patient satisfaction of CT-guided versus fluoroscopic-guided genicular nerve ablation in the management of knee osteoarthritis. By rigorously evaluating these techniques, the findings will inform clinical decision-making, optimize treatment strategies, and pave the way for future research aimed at enhancing outcomes for patients suffering from chronic knee pain.
- Conditions
- Osteoarthritis, Knee
- Being tested
- CT-Guided Genicular Nerve Ablation, Fluoroscopic-Guided Genicular Nerve Ablation
- Keywords
- Knee Osteoarthritis, Genicular Nerve Ablation, CT-guided Ablation, Fluoroscopic-guided Ablation, Pain Management, Minimally Invasive Procedures, Patient Satisfaction
- Medical subject headings
- Osteoarthritis, Knee, Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-Guided Genicular Nerve AblationProcedure or surgery
This procedure involves using computed tomography (CT) imaging to guide the precise placement of a needle for the ablation of genicular nerves in the knee. The goal is to disrupt the pain signals caused by osteoarthritis, providing long-term pain relief. The intervention is performed under local anesthesia and is aimed at patients who have not responded adequately to conservative pain management strategies.
Fluoroscopic-Guided Genicular Nerve AblationProcedure or surgery
This procedure utilizes fluoroscopy to accurately guide the needle placement for the ablation of genicular nerves associated with osteoarthritis knee pain. The technique focuses on minimizing pain and improving functional mobility by disrupting nerve pathways that transmit pain signals. Like the CT-guided approach, it is intended for use in patients whose symptoms have not been sufficiently managed with non-invasive treatments.
| Study group | Role | What they receive |
|---|---|---|
| CT-Guided Genicular Nerve Ablation | Experimental | Participants in this arm will undergo genicular nerve ablation using computed tomography (CT) guidance. The procedure involves precise needle placement based on CT imaging to effectively target the genicular nerves responsible for transmitting pain signals from the knee. Receives: Procedure: CT-Guided Genicular Nerve Ablation |
| Fluoroscopic-Guided Genicular Nerve Ablation | Active comparator | Participants in this arm will receive genicular nerve ablation using fluoroscopic guidance. The procedure utilizes real-time fluoroscopy to guide needle placement for the ablation of the genicular nerves. Receives: Procedure: Fluoroscopic-Guided Genicular Nerve Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Knee Pain
This measure assesses the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement.
Measured: 3 months post-procedure
Secondary outcomes (3)
Improvement in Knee Function
Assessed by changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, which measure pain, stiffness, and physical function of the knee and hip joints. A lower WOMAC score indicates better joint function.
Measured: Assessed at baseline, 1 month, 3 months, and 6 months post-procedure
Incidence of Procedure-Related Adverse Events
Monitoring and recording any adverse events related to the genicular nerve ablation procedures
Measured: From the time of procedure up to 6 months
Patient Satisfaction with the Procedure
Measured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure.
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start29 Sep 2024
- Primary completion30 Apr 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Awad Bessar, Zagazig University
- Investigators
- Ahmed A Bessar, MD, PhD, Principal investigator, Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514703
- Sponsor's protocol ID
- CTFGNA-KOA
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06514703
- Acronym / sponsor ID
- CTFGNA-KOA
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee Osteoarthritis, Genicular Nerve Ablation, CT-guided Ablation, Fluoroscopic-guided Ablation, Pain Management, Minimally Invasive Procedures, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 29 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 23 Jul 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.
The goal of this study is to evaluate the comparative effectiveness of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain and improving function in adults diagnosed with knee osteoarthritis refractory to conservative treatment.
The main questions it aims to answer are:
- Does CT-guided genicular nerve ablation provide superior pain relief compared to fluoroscopic-guided genicular nerve ablation?
- Is there a significant difference in functional improvement between the two techniques?
Researchers will compare the outcomes between the CT-guided and fluoroscopic-guided groups to determine which method achieves better pain relief, functional enhancement, safety profile, and patient satisfaction.
Participants will:
- Undergo either CT-guided or fluoroscopic-guided genicular nerve ablation.
- Attend scheduled follow-up visits to assess pain levels, knee function, and any adverse events.
- Complete standardized questionnaires to provide feedback on pain relief, functional improvement, and overall satisfaction with the procedure.
Detailed description
Background:
Knee osteoarthritis is a chronic degenerative joint disease affecting millions worldwide, characterized by progressive cartilage loss, inflammation, and pain. Despite various treatment options such as intra-articular corticosteroids, viscosupplementation, and PRP injections, many patients experience inadequate relief or adverse effects. Genicular nerve ablation has emerged as a promising minimally invasive technique to alleviate chronic knee pain by interrupting pain transmission from the genicular nerves to the central nervous system.
Rationale:
The rationale for comparing CT-guided and fluoroscopic-guided genicular nerve ablation lies in optimizing treatment outcomes while ensuring patient safety and satisfaction. CT-guided procedures offer unparalleled precision in nerve localization, potentially enhancing the accuracy of nerve ablation and improving clinical outcomes. However, this method involves higher radiation exposure compared to fluoroscopic guidance, which utilizes real-time imaging with lower radiation doses. Understanding which approach provides superior pain relief, functional improvement, and patient satisfaction is crucial for optimizing treatment protocols and guiding clinical practice.
Objectives:
Primary Objective:
- Evaluate the efficacy of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain, as measured by the visual analog scale (VAS), at 3 months post-procedure.
Secondary Objectives:
- Evaluate changes in knee function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a validated scoring system specifically designed for osteoarthritis.
- Monitor and document any procedure-related adverse events to compare the safety profiles of both techniques.
- Evaluate patient satisfaction using the structured Patient Satisfaction Questionnaire (PSQ)
Study Design:
This study is a randomized controlled trial (RCT) aimed at evaluating the comparative effectiveness of CT-guided versus fluoroscopic-guided genicular nerve ablation. Eligible patients will be randomly allocated to one of the two treatment groups. Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments.
Participants:
- Inclusion Criteria: Adults aged 45-80 diagnosed with knee osteoarthritis refractory to conservative treatment, characterized by persistent knee pain despite medication and physical therapy.
- Exclusion Criteria: Patients with contraindications to genicular nerve ablation procedures (e.g., allergy to local anesthetics, active infection at the procedure site), or recent knee surgery within the last six months.
Interventions:
- CT-guided Genicular Nerve Ablation: Patients will undergo CT-guided genicular nerve ablation, involving meticulous planning of needle placement under CT imaging to accurately target the genicular nerves responsible for knee pain. Ablation parameters will be standardized to ensure consistency across procedures.
- Fluoroscopic-guided Genicular Nerve Ablation: Patients assigned to this group will undergo genicular nerve ablation under fluoroscopic guidance, utilizing real-time X-ray imaging to guide needle placement and confirm adequate nerve coverage before ablation.
Outcomes:
- Primary Outcome: Reduction in knee pain measured by visual analog scale (VAS) at 3 months post-procedure.
- Secondary Outcomes
- Improvement in knee function measured by changes in WOMAC scores over the follow-up period.
- Incidence and nature of any procedure-related adverse events
- Patient-reported outcomes regarding satisfaction, using the structured PSQ
Follow-Up:
Participants will be closely monitored post-procedure with scheduled follow-up visits at 1 week, 1 month, 3 months, and 6 months. These visits will include clinical assessments, pain evaluations, functional tests, and documentation of any adverse events.
Conclusion:
This study aims to provide valuable insights into the comparative effectiveness, safety, and patient satisfaction of CT-guided versus fluoroscopic-guided genicular nerve ablation in the management of knee osteoarthritis. By rigorously evaluating these techniques, the findings will inform clinical decision-making, optimize treatment strategies, and pave the way for future research aimed at enhancing outcomes for patients suffering from chronic knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-Guided Genicular Nerve Ablation | Experimental | Procedure: CT-Guided Genicular Nerve AblationParticipants in this arm will undergo genicular nerve ablation using computed tomography (CT) guidance. The procedure involves precise needle placement based on CT imaging to effectively target the genicular nerves responsible for transmitting pain signals from the knee. |
| Fluoroscopic-Guided Genicular Nerve Ablation | Active comparator | Procedure: Fluoroscopic-Guided Genicular Nerve AblationParticipants in this arm will receive genicular nerve ablation using fluoroscopic guidance. The procedure utilizes real-time fluoroscopy to guide needle placement for the ablation of the genicular nerves. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 45 to 80 years.
- Diagnosed with knee osteoarthritis.
- Knee osteoarthritis refractory to conservative treatment.
- Able to provide informed consent.
- Agree to follow the study procedures and attend follow-up visits.
Key exclusion criteria (5 listed)
- Prior knee surgery within the last six months.
- Contraindications to genicular nerve ablation (e.g., certain types of infections, bleeding disorders).
- Severe comorbid conditions that may interfere with the study outcomes (e.g., rheumatoid arthritis, other severe autoimmune diseases).
- Current participation in another clinical trial that could interfere with the outcomes of this study.
- Allergy or sensitivity to the materials used in the ablation procedures.
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 |
|---|---|---|
| CT-Guided Genicular Nerve AblationThis procedure involves using computed tomography (CT) imaging to guide the precise placement of a needle for the ablation of genicular nerves in the knee. The goal is to disrupt the pain signals caused by osteoarthritis, providing long-term pain relief. The intervention is performed under local anesthesia and is aimed at patients who have not responded adequately to conservative pain management strategies. | Procedure or surgery | CT-Guided Genicular Nerve Ablation |
| Fluoroscopic-Guided Genicular Nerve AblationThis procedure utilizes fluoroscopy to accurately guide the needle placement for the ablation of genicular nerves associated with osteoarthritis knee pain. The technique focuses on minimizing pain and improving functional mobility by disrupting nerve pathways that transmit pain signals. Like the CT-guided approach, it is intended for use in patients whose symptoms have not been sufficiently managed with non-invasive treatments. | Procedure or surgery | Fluoroscopic-Guided Genicular Nerve Ablation |
Primary outcome
Reduction in Knee Pain
Time frame: 3 months post-procedure
This measure assesses the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement.
3 secondary outcomes
Improvement in Knee Function
Time frame: Assessed at baseline, 1 month, 3 months, and 6 months post-procedure
Incidence of Procedure-Related Adverse Events
Time frame: From the time of procedure up to 6 months
Patient Satisfaction with the Procedure
Time frame: 3 months post-procedure
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 23 Sep 2026.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
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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.
Ahmed A Bessar, MD, PhD principal investigator
Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-Guided Genicular Nerve Ablation and Fluoroscopic-Guided Genicular Nerve Ablation in people with Osteoarthritis, Knee, run by Zagazig 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 5 inclusion and 5 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 23 Sep 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?
Reduction in Knee Pain (time frame: 3 months post-procedure). 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 23 Sep 2026.