Knee OsteoarthritisNCT06239649
The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty
An observational study of Knee Osteoarthritis and Knee Pain Chronic, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic
- What is being tested?
- Genicular nerve Radiofrequency Ablation block
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2023to 1 Jun 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli, Pamukkale, 20100
MURAT I KIRBAS, MD, 506-783-0083 ext. +90, mibrahimkirbas@gmail.com
Harun Reşit Güngör, 532-234-3770 ext. +90, hrgungor@gmail.com
About this study
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.
Read the detailed description
One of the most important components of surgery using Fast-Track is the application of effective and well-monitored pain treatment. Post-surgical pain negatively affects the patient's early mobilization. Reduction in pain after TKA(Total Knee Arthroplasty) may not only increase short-term functional results but also increase the patient's overall satisfaction.
Genicular Nerve Radiofrequency Ablation (GNRFA) is a non-surgical treatment increasingly used in patients with advanced knee osteoarthritis. Previous studies have shown this to be an effective and safe method to reduce pain and improve functionality in this patient population.
Neurolysis of genicular nerves with radiofrequency (RF) may be useful to relieve pain and improve both function and quality of life in patients with post-TKA pain.
Investigators thought that reducing the pain of patients who underwent TKA with Fast-track in the postoperative period would contribute to early mobilization and therefore rapid functional recovery. As a result of previous studies, investigators know that genicular nerve neurolysis with RF Ablation in the preoperative period provides a reduction in postoperative pain.
Investigators routinely apply TKA applications in clinic with Fast-Track. In investigators hospital's algology outpatient clinic, genicular nerve RF ablation is routinely performed under USG or fluoroscopy guidance. In investigators study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic
- Being tested
- Genicular nerve Radiofrequency Ablation block
- Keywords
- Fast-Track Total Knee Arthroplasty, Genicular Nerve Block, Radiofrequency Ablation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular nerve Radiofrequency Ablation blockProcedure or surgery
Genicular nerve Radiofrequency Ablation block
| Study group | Role | What they receive |
|---|---|---|
| TKA with radiofrequency ablation genicular nerve block | TKA with radiofrequency ablation genicular nerve block Receives: Procedure: Genicular nerve Radiofrequency Ablation block | |
| TKA without nerve block | TKA without radiofrequency ablation genicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain preoperative
Visual Analog Scale used to assess pain
Measured: Baseline (preoperatively)
Pain postoperative 1
Visual Analog Scale used to assess pain
Measured: at postoperative sixth weeks
Pain postoperative 2
Visual Analog Scale used to assess pain
Measured: at postoperative twelfth weeks
Knee Range of Motion preoperative
Digital goniometer used to assess knee range of motion
Measured: Baseline (preoperatively)
Knee Range of Motion postoperative 1
Digital goniometer used to assess knee range of motion
Measured: at postoperative sixth week
Knee Range of Motion postoperative 2
Digital goniometer used to assess knee range of motion
Measured: at postoperative twelfth week
Quadriceps muscle strength preoperative
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer
Measured: Baseline (preoperatively)
Quadriceps muscle strength postoperative 1
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer
Measured: at postoperative sixth weeks
Quadriceps muscle strength postoperative 2
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer
Measured: 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
Measured: 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
Measured: 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
Measured: at postoperative twelfth week
Performance-based activity limitations-preoperative
30-sec chair-stand test and stair-climb test are used
Measured: Baseline (preoperatively)
Performance-based activity limitations-preoperative 1
30-sec chair-stand test and stair-climb test are used
Measured: at postoperative sixth weeks
Performance-based activity limitations-preoperative 2
30-sec chair-stand test and stair-climb test are used
Measured: at postoperative twelfth week
Quality of life-preoperative
Short Form-36 (SF-36) is used
Measured: Baseline (preoperatively)
Quality of life-preoperative 1
Short Form-36 (SF-36) is used
Measured: at postoperative sixth weeks
Quality of life-preoperative 2
Short Form-36 (SF-36) is used
Measured: 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)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Length of operation time
Length of operation time is measured in minutes during the surgery
Measured: the surgery
Amount of blood loss
Amount of blood loss is measured from the suction drainage (unit-milliliters)
Measured: through study completion, an average of 1 year
postoperative component alignments
Long leg radiographs of the patients are evaluated postoperatively by using a digital orthopedic templating software-Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start19 Oct 2023
- Primary completion30 May 2024
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun Resit Gungor, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239649
- Sponsor's protocol ID
- 2023PAUOrto
- Status last verified
- Jun 2025
- First submitted
- 27 Dec 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35960987Lloyd 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.
PubMed 22507716Sullivan 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.
PubMed 21764515
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06239649
- Acronym / sponsor ID
- 2023PAUOrto
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic
- Keywords
- Fast-Track Total Knee Arthroplasty, Genicular Nerve Block, Radiofrequency Ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 2 Feb 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.
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.
Detailed description
One of the most important components of surgery using Fast-Track is the application of effective and well-monitored pain treatment. Post-surgical pain negatively affects the patient's early mobilization. Reduction in pain after TKA(Total Knee Arthroplasty) may not only increase short-term functional results but also increase the patient's overall satisfaction.
Genicular Nerve Radiofrequency Ablation (GNRFA) is a non-surgical treatment increasingly used in patients with advanced knee osteoarthritis. Previous studies have shown this to be an effective and safe method to reduce pain and improve functionality in this patient population.
Neurolysis of genicular nerves with radiofrequency (RF) may be useful to relieve pain and improve both function and quality of life in patients with post-TKA pain.
Investigators thought that reducing the pain of patients who underwent TKA with Fast-track in the postoperative period would contribute to early mobilization and therefore rapid functional recovery. As a result of previous studies, investigators know that genicular nerve neurolysis with RF Ablation in the preoperative period provides a reduction in postoperative pain.
Investigators routinely apply TKA applications in clinic with Fast-Track. In investigators hospital's algology outpatient clinic, genicular nerve RF ablation is routinely performed under USG or fluoroscopy guidance. In investigators study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKA with radiofrequency ablation genicular nerve block | – | Procedure: Genicular nerve Radiofrequency Ablation blockTKA with radiofrequency ablation genicular nerve block |
| TKA without nerve block | – | –TKA without radiofrequency ablation genicular nerve block |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
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 |
|---|---|---|
| Genicular nerve Radiofrequency Ablation blockGenicular nerve Radiofrequency Ablation block | Procedure or surgery | TKA with radiofrequency ablation genicular nerve block |
Primary outcome
Pain preoperative
Time frame: Baseline (preoperatively)
Visual Analog Scale used to assess pain
Pain postoperative 1
Time frame: at postoperative sixth weeks
Visual Analog Scale used to assess pain
Pain postoperative 2
Time frame: at postoperative twelfth weeks
Visual Analog Scale used to assess pain
Knee Range of Motion preoperative
Time frame: Baseline (preoperatively)
Digital goniometer used to assess knee range of motion
Knee Range of Motion postoperative 1
Time frame: at postoperative sixth week
Digital goniometer used to assess knee range of motion
Knee Range of Motion postoperative 2
Time frame: at postoperative twelfth week
Digital goniometer used to assess knee range of motion
Quadriceps muscle strength preoperative
Time frame: Baseline (preoperatively)
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer
Quadriceps muscle strength postoperative 1
Time frame: at postoperative sixth weeks
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer
Quadriceps muscle strength postoperative 2
Time frame: at postoperative twelfth week
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer
Patient-reported activity limitations preoperative
Time frame: Baseline (preoperatively)
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Patient-reported activity limitations preoperative 1
Time frame: at postoperative sixth weeks
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Patient-reported activity limitations preoperative 2
Time frame: at postoperative twelfth week
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Performance-based activity limitations-preoperative
Time frame: Baseline (preoperatively)
30-sec chair-stand test and stair-climb test are used
Performance-based activity limitations-preoperative 1
Time frame: at postoperative sixth weeks
30-sec chair-stand test and stair-climb test are used
Performance-based activity limitations-preoperative 2
Time frame: at postoperative twelfth week
30-sec chair-stand test and stair-climb test are used
Quality of life-preoperative
Time frame: Baseline (preoperatively)
Short Form-36 (SF-36) is used
Quality of life-preoperative 1
Time frame: at postoperative sixth weeks
Short Form-36 (SF-36) is used
Quality of life-preoperative 2
Time frame: at postoperative twelfth week
Short Form-36 (SF-36) is used
Length of hospital stay
Time frame: through study completion, an average of 1 year
Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours)
3 secondary outcomes
Length of operation time
Time frame: the surgery
Amount of blood loss
Time frame: through study completion, an average of 1 year
postoperative component alignments
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 35960987Stake 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.
- Background: PubMed 22507716Lloyd 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.
- Background: PubMed 21764515Sullivan 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.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Knee Pain Chronic, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Jun 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HARUN R GUNGOR, MD (258-296-5690 ext. +90, hrgungor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain preoperative (time frame: Baseline (preoperatively)). The study lists 19 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 NCT06239649, which also lists 3 linked publications.
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 4 Jun 2025.