Total Knee Arthroplasty Secondary to OsteoarthritisNCT07727551
Preoperative Genicular Radiofrequency and Functional Outcomes After Total Knee Arthroplasty
A study testing Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds in people with Total Knee Arthroplasty Secondary to Osteoarthritis and 18 Years and Older, run by Anesthesiology department Iris South Hospitals at 1 site in Belgium.
Trial summary
Knee osteoarthritis (OA) is a degenerative joint disease characterized by progressive cartilage wear, leading to pain, stiffness, and joint swelling. It is highly prevalent in aging populations and is strongly associated with obesity and previous joint injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Total Knee Arthroplasty Secondary to Osteoarthritis, 18 Years and Older
- What is being tested?
- Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2026to Jun 2027
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60
- Elective total knee arthroplasty
- 2 to 6 weeks before the procedure
- AND either of:
- BMI > 35
- Diabetes under insulin
Show all 17Show fewer
- Anxiety disorder
- Treated depressive disorder
- Widespread pain disorder or central sensitisation disorder
- Chronic pain at a different site
- Catastrophising
- Sleep disorder
- preoperative EVA 7 or more
- OKS 25 or less
- WOMAC 50 or more
- Previous total knee arthroplasty (contralateral)
- Knee CRPS
Who cannot join
- Previous prosthetic surgery on the same knee (i.e. redo surgery, open reduction internal fixation, knee hemiarthroplasty)
- Major psychiatric disorder (i.e. major depression, schizophrenia)
- Patient refusal
- Inability to communicate with the patient and obtain informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Iris South Hospitals
Brussels, 1050
Stefano Doria, MD, +32492514178, sdoria@his-izz.be
About this study
Official title: Enhancing Functional Outcomes in Total Knee Arthroplasty: the Role of Preoperative Genicular Radiofrequency
Knee osteoarthritis (OA) is a degenerative joint disease characterized by progressive cartilage wear, leading to pain, stiffness, and joint swelling. It is highly prevalent in aging populations and is strongly associated with obesity and previous joint injury. OA affects millions of individuals worldwide, with incidence and prevalence increasing markedly with age and resulting in significant functional disability
The primary therapeutic goals in the management of knee osteoarthritis are pain reduction and improvement of joint mobility.
Read more
Total knee arthroplasty is considered one of the most effective surgical interventions for relieving pain and restoring function in patients with severe knee osteoarthritis. Nevertheless, residual pain and limited functional improvement remain the most frequent causes of patient dissatisfaction following TKA
Genicular nerve radiofrequency ablation (GNRFA) has emerged as an innovative treatment option for symptomatic knee osteoarthritis. This technique has been shown to reduce pain and improve function, with clinical benefits often observed as early as one week after treatment. GNRFA consistently provides short-term pain relief (3 to 6 months) and, in some cases, longer-lasting benefits.
The hypothesis tested in this study is whether GNRFA performed at least two weeks preoperatively can reduce postoperative pain and improve postoperative function.
Read the detailed description
The International Association for the Study of Pain (IASP) has recently updated the definition of pain as "An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage." This definition is complemented by explanatory notes emphasizing the subjective nature of pain and its modulation by biological, psychological, and social factors. Pain may therefore have detrimental effects on physical function as well as on social and psychological well-being.
Chronic postsurgical pain (CPSP) is defined as pain that develops after a surgical procedure and persists for at least three months following surgery. Historically, the risk of developing CPSP has been underestimated. Available data indicate that the incidence of postsurgical pain ranges from 5% to 85%, depending on the type of surgical procedure. Severe CPSP occurs in approximately 2% to 15% of patients, with reported rates of 17-21% after abdominal surgery, 6-55% after caesarean section, 5-65% after thoracotomy, 27% after hip arthroplasty, and 13-20% after knee arthroplasty. Specifically, after total knee arthroplasty (TKA), pain severity tends to plateau between three and six months postoperatively.
Knee osteoarthritis (OA) is a degenerative joint disease characterized by progressive cartilage wear, leading to pain, stiffness, and joint swelling. It is highly prevalent in aging populations and is strongly associated with obesity and previous joint injury. OA affects millions of individuals worldwide, with incidence and prevalence increasing markedly with age and resulting in significant functional disability. Approximately 23% of individuals over 40 years of age are affected, with prevalence rising to nearly 80% in older populations. Major risk factors include aging, elevated body mass index (BMI), joint injury, repetitive joint overload, and genetic predisposition. Since the mid-20th century, both prevalence and incidence have doubled, largely due to increased life expectancy and rising obesity rates.
The primary therapeutic goals in the management of knee osteoarthritis are pain reduction and improvement of joint mobility. Treatment follows a stepwise approach, including exercise therapy, weight reduction, physiotherapy, analgesics, nonsteroidal anti-inflammatory drugs, intra-articular corticosteroid or hyaluronic acid injections, arthroscopic procedures, and, in advanced disease, total joint replacement followed by structured rehabilitation.
Total knee arthroplasty is considered one of the most effective surgical interventions for relieving pain and restoring function in patients with severe knee osteoarthritis. Nevertheless, residual pain and limited functional improvement remain the most frequent causes of patient dissatisfaction following TKA. Both patients and surgeons may consider the procedure unsuccessful when long-term pain relief and functional recovery are inadequate. Furthermore, older adults experiencing chronic pain after TKA may suffer from impaired social relationships and social isolation. Chronic pain in this population is also associated with depression, anxiety, sleep disturbances, and long-term opioid use, all of which negatively affect health-related quality of life.
The most relevant variables associated with the development of chronic pain following TKA can be broadly categorized into demographic and preoperative factors. Demographic factors include age and body mass index. Preoperative factors with strong supporting evidence include the severity of preoperative pain, chronic widespread pain, maladaptive health beliefs, sleep disturbances, central sensitization, anxiety, and impaired preoperative function.
Consequently, prevention of chronic pain after TKA relies on a multimodal, patient-centered approach initiated in the preoperative period. This strategy includes optimization of the patient's overall condition, active patient involvement in the surgical pathway, preemptive analgesia (such as peripheral nerve blocks and local anesthesia), optimization of surgical precision thanks to new devices (Rosa - Robotic Surgical Assistant), early initiation of physical therapy, effective management of acute postoperative pain using cryotherapy, limb elevation, and pharmacological treatment, as well as the integration of psychosocial support.
Among the various risk factors, particular attention should be given to the intensity of preoperative pain, which has been identified as a major predictor of CPSP. Strong evidence supporting this association has been reported in a systematic review published in 2024.
Preoperative pain management may be achieved through several approaches, including pharmacological therapy, physiotherapy, ketamine infusion, and locoregional anesthesia techniques such as genicular nerve blocks and adductor canal blocks. Among these modalities, radiofrequency-based interventions appear to provide the most sustained analgesic effects.
Electrical stimulation techniques have long been recognized for their analgesic properties. Among them, radiofrequency is one of the most widely used modalities in the treatment of chronic pain. Two main types of radiofrequency are currently employed: continuous and pulsed. Continuous radiofrequency (CRF) delivers continuous electrical stimulation, generating high temperatures (up to 80°C) at the target nerve or tissue, resulting in neural ablation. With increasing clinical experience, it became evident that effective pain control could also be achieved at lower temperatures. Subsequent research demonstrated that the therapeutic effect of pulsed radiofrequency (PRF) is primarily related to the electrical field generated around the target nerve rather than thermal ablation.
Genicular nerve radiofrequency ablation (GNRFA) has emerged as an innovative treatment option for symptomatic knee osteoarthritis. This technique has been shown to reduce pain and improve function, with clinical benefits often observed as early as one week after treatment. GNRFA consistently provides short-term pain relief (3 to 6 months) and, in some cases, longer-lasting benefits.
Performing GNRFA at least one week prior to TKA, as part of a comprehensive multimodal perioperative strategy, can enhance surgical outcomes by reducing preoperative pain and improving functional status, thereby placing patients in a more favorable condition to undergo surgery.
- Being tested
- Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds
- Keywords
- Radiofrequency ablation, Genicular nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 secondsProcedure or surgery
Radiofrequency ablation of the genicular nerves (upper medial, upper lateral and lower medial nerves), at 42 C for 120 seconds each, after injection of 5ml lidocaine 2% for each nerve.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Experimental | Patients in this arm will receive genicular nerve radiofrequency ablation between 2 to 6 weeks before undergoing elective total knee replacement Receives: Procedure: Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds |
| Control | No intervention | Patients in this group will not receive any intervention before undergoing elective total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Oxford Knee Score
A difference of 5 points in Oxford Knee Score between groups will be considered significant.
Range: 0 to 48, higher is better
Measured: Three months post-operative
Western Ontario and McMaster Universities Osteoarthritis Index postoperative
A 12 point difference will be considered significant Range: 0 to 96, higher is better
Measured: 3 months postoperatively
Secondary outcomes (4)
Numerical rating scale pain postoperative
At effort and at rest. Range 0 to 10, higher is more pain (worse)
Measured: Three months post-operatively
Chronic regional pain syndrome post-operatively
As evaluated by Budapest criteria. 4 signs and 4 symptoms (sensory, vasomotor, sudomotor, motor/trophic), 3 symptoms and 2 signs are necessary for diagnosis. These are diagnostic criteria for a yes or no diagnosis of Chronci Regional Pain Syndrome
Measured: 3 months post-operatively
Morphine consumption
As evaluated by morphine equivalents
Measured: Three months post-operatively
Patient satisfaction
11 point Likert scale, higher is better
Measured: Three months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Total Knee Arthroplasty Secondary to OsteoarthritisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anesthesiology department Iris South Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Zuccarini, MD, Principal investigator, Iris South Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727551
- Sponsor's protocol ID
- CEHIS2026/05
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Murray DW, Fitzpatrick R, Rogers K, Pandit H, Beard DJ, Carr AJ, Dawson J. The use of the Oxford hip and knee scores. J Bone Joint Surg Br. 2007 Aug;89(8):1010-4. doi: 10.1302/0301-620X.89B8.19424.
PubMed 17785736Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.
PubMed 15208174Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001 Aug;45(4):384-91. doi: 10.1002/1529-0131(200108)45:43.0.CO;2-0.
PubMed 11501727Clement ND, Afzal I, Demetriou C, Deehan DJ, Field RE, Kader D. There is no clinically important difference in the Oxford knee scores between one and two years after total knee arthroplasty: The one-year score could be used as the benchmark timepoint to assess outcome. Knee. 2020 Aug;27(4):1212-1218. doi: 10.1016/j.knee.2020.05.015. Epub 2020 Jun 25.
PubMed 32711884Jordan K, Dunn KM, Lewis M, Croft P. A minimal clinically important difference was derived for the Roland-Morris Disability Questionnaire for low back pain. J Clin Epidemiol. 2006 Jan;59(1):45-52. doi: 10.1016/j.jclinepi.2005.03.018. Epub 2005 Nov 4.
PubMed 16360560Hasoon J, Orhurhu VJ, Yazdi C. Genicular Nerve Blocks for the Management of Chronic Knee Pain Related to Osteoarthritis - A Case Series. Orthop Rev (Pavia). 2024 Dec 3;16:126046. doi: 10.52965/001c.126046. eCollection 2024.
PubMed 39640541Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.
PubMed 36369781GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.
PubMed 18915634Fari G, de Sire A, Fallea C, Albano M, Grossi G, Bettoni E, Di Paolo S, Agostini F, Bernetti A, Puntillo F, Mariconda C. Efficacy of Radiofrequency as Therapy and Diagnostic Support in the Management of Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Feb 26;12(3):600. doi: 10.3390/diagnostics12030600.
PubMed 35328153Kvarstein G, Mawe L, Indahl A, Hol PK, Tennoe B, Digernes R, Stubhaug A, Tonnessen TI, Beivik H. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy--a 12-month follow-up. Pain. 2009 Oct;145(3):279-286. doi: 10.1016/j.pain.2009.05.001. Epub 2009 Aug 3.
PubMed 19647940van Kleef M, Barendse GA, Kessels A, Voets HM, Weber WE, de Lange S. Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain. Spine (Phila Pa 1976). 1999 Sep 15;24(18):1937-42. doi: 10.1097/00007632-199909150-00013.
PubMed 10515020Koh W, Choi SS, Karm MH, Suh JH, Leem JG, Lee JD, Kim YK, Shin J. Treatment of chronic lumbosacral radicular pain using adjuvant pulsed radiofrequency: a randomized controlled study. Pain Med. 2015 Mar;16(3):432-41. doi: 10.1111/pme.12624. Epub 2014 Dec 19.
PubMed 25530347Shanthanna H, Chan P, McChesney J, Thabane L, Paul J. Pulsed radiofrequency treatment of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain: a randomized, placebo-controlled pilot study. J Pain Res. 2014 Jan 10;7:47-55. doi: 10.2147/JPR.S55749. eCollection 2014 Jan 10.
PubMed 24453500Li J, Guan T, Zhai Y, Zhang Y. Risk factors of chronic postoperative pain after total knee arthroplasty: a systematic review. J Orthop Surg Res. 2024 May 29;19(1):320. doi: 10.1186/s13018-024-04778-w.
PubMed 38811979Wylde V, Blom AW. The failure of survivorship. J Bone Joint Surg Br. 2011 May;93(5):569-70. doi: 10.1302/0301-620X.93B5.26687. No abstract available.
PubMed 21511918
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Functional Outcomes in Total Knee Arthroplasty: the Role of Preoperative Genicular Radiofrequency
- ClinicalTrials.gov ID
- NCT07727551
- Acronym / sponsor ID
- CEHIS2026/05
- Keywords
- Radiofrequency ablation, Genicular nerve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Anesthesiology department Iris South HospitalsUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Jul 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.
Knee osteoarthritis (OA) is a degenerative joint disease characterized by progressive cartilage wear, leading to pain, stiffness, and joint swelling. It is highly prevalent in aging populations and is strongly associated with obesity and previous joint injury. OA affects millions of individuals worldwide, with incidence and prevalence increasing markedly with age and resulting in significant functional disability
The primary therapeutic goals in the management of knee osteoarthritis are pain reduction and improvement of joint mobility.
Total knee arthroplasty is considered one of the most effective surgical interventions for relieving pain and restoring function in patients with severe knee osteoarthritis. Nevertheless, residual pain and limited functional improvement remain the most frequent causes of patient dissatisfaction following TKA
Genicular nerve radiofrequency ablation (GNRFA) has emerged as an innovative treatment option for symptomatic knee osteoarthritis. This technique has been shown to reduce pain and improve function, with clinical benefits often observed as early as one week after treatment. GNRFA consistently provides short-term pain relief (3 to 6 months) and, in some cases, longer-lasting benefits.
The hypothesis tested in this study is whether GNRFA performed at least two weeks preoperatively can reduce postoperative pain and improve postoperative function.
Detailed description
The International Association for the Study of Pain (IASP) has recently updated the definition of pain as "An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage." This definition is complemented by explanatory notes emphasizing the subjective nature of pain and its modulation by biological, psychological, and social factors. Pain may therefore have detrimental effects on physical function as well as on social and psychological well-being.
Chronic postsurgical pain (CPSP) is defined as pain that develops after a surgical procedure and persists for at least three months following surgery. Historically, the risk of developing CPSP has been underestimated. Available data indicate that the incidence of postsurgical pain ranges from 5% to 85%, depending on the type of surgical procedure. Severe CPSP occurs in approximately 2% to 15% of patients, with reported rates of 17-21% after abdominal surgery, 6-55% after caesarean section, 5-65% after thoracotomy, 27% after hip arthroplasty, and 13-20% after knee arthroplasty. Specifically, after total knee arthroplasty (TKA), pain severity tends to plateau between three and six months postoperatively.
Knee osteoarthritis (OA) is a degenerative joint disease characterized by progressive cartilage wear, leading to pain, stiffness, and joint swelling. It is highly prevalent in aging populations and is strongly associated with obesity and previous joint injury. OA affects millions of individuals worldwide, with incidence and prevalence increasing markedly with age and resulting in significant functional disability. Approximately 23% of individuals over 40 years of age are affected, with prevalence rising to nearly 80% in older populations. Major risk factors include aging, elevated body mass index (BMI), joint injury, repetitive joint overload, and genetic predisposition. Since the mid-20th century, both prevalence and incidence have doubled, largely due to increased life expectancy and rising obesity rates.
The primary therapeutic goals in the management of knee osteoarthritis are pain reduction and improvement of joint mobility. Treatment follows a stepwise approach, including exercise therapy, weight reduction, physiotherapy, analgesics, nonsteroidal anti-inflammatory drugs, intra-articular corticosteroid or hyaluronic acid injections, arthroscopic procedures, and, in advanced disease, total joint replacement followed by structured rehabilitation.
Total knee arthroplasty is considered one of the most effective surgical interventions for relieving pain and restoring function in patients with severe knee osteoarthritis. Nevertheless, residual pain and limited functional improvement remain the most frequent causes of patient dissatisfaction following TKA. Both patients and surgeons may consider the procedure unsuccessful when long-term pain relief and functional recovery are inadequate. Furthermore, older adults experiencing chronic pain after TKA may suffer from impaired social relationships and social isolation. Chronic pain in this population is also associated with depression, anxiety, sleep disturbances, and long-term opioid use, all of which negatively affect health-related quality of life.
The most relevant variables associated with the development of chronic pain following TKA can be broadly categorized into demographic and preoperative factors. Demographic factors include age and body mass index. Preoperative factors with strong supporting evidence include the severity of preoperative pain, chronic widespread pain, maladaptive health beliefs, sleep disturbances, central sensitization, anxiety, and impaired preoperative function.
Consequently, prevention of chronic pain after TKA relies on a multimodal, patient-centered approach initiated in the preoperative period. This strategy includes optimization of the patient's overall condition, active patient involvement in the surgical pathway, preemptive analgesia (such as peripheral nerve blocks and local anesthesia), optimization of surgical precision thanks to new devices (Rosa - Robotic Surgical Assistant), early initiation of physical therapy, effective management of acute postoperative pain using cryotherapy, limb elevation, and pharmacological treatment, as well as the integration of psychosocial support.
Among the various risk factors, particular attention should be given to the intensity of preoperative pain, which has been identified as a major predictor of CPSP. Strong evidence supporting this association has been reported in a systematic review published in 2024.
Preoperative pain management may be achieved through several approaches, including pharmacological therapy, physiotherapy, ketamine infusion, and locoregional anesthesia techniques such as genicular nerve blocks and adductor canal blocks. Among these modalities, radiofrequency-based interventions appear to provide the most sustained analgesic effects.
Electrical stimulation techniques have long been recognized for their analgesic properties. Among them, radiofrequency is one of the most widely used modalities in the treatment of chronic pain. Two main types of radiofrequency are currently employed: continuous and pulsed. Continuous radiofrequency (CRF) delivers continuous electrical stimulation, generating high temperatures (up to 80°C) at the target nerve or tissue, resulting in neural ablation. With increasing clinical experience, it became evident that effective pain control could also be achieved at lower temperatures. Subsequent research demonstrated that the therapeutic effect of pulsed radiofrequency (PRF) is primarily related to the electrical field generated around the target nerve rather than thermal ablation.
Genicular nerve radiofrequency ablation (GNRFA) has emerged as an innovative treatment option for symptomatic knee osteoarthritis. This technique has been shown to reduce pain and improve function, with clinical benefits often observed as early as one week after treatment. GNRFA consistently provides short-term pain relief (3 to 6 months) and, in some cases, longer-lasting benefits.
Performing GNRFA at least one week prior to TKA, as part of a comprehensive multimodal perioperative strategy, can enhance surgical outcomes by reducing preoperative pain and improving functional status, thereby placing patients in a more favorable condition to undergo surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Experimental | Procedure: Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 secondsPatients in this arm will receive genicular nerve radiofrequency ablation between 2 to 6 weeks before undergoing elective total knee replacement |
| Control | No intervention | –Patients in this group will not receive any intervention before undergoing elective total knee replacement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age between 18 and 60
- Elective total knee arthroplasty
- 2 to 6 weeks before the procedure
- BMI > 35
- Diabetes under insulin
Key exclusion criteria (4 listed)
- Previous prosthetic surgery on the same knee (i.e. redo surgery, open reduction internal fixation, knee hemiarthroplasty)
- Major psychiatric disorder (i.e. major depression, schizophrenia)
- Patient refusal
- Inability to communicate with the patient and obtain informed consent
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 |
|---|---|---|
| Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 secondsRadiofrequency ablation of the genicular nerves (upper medial, upper lateral and lower medial nerves), at 42 C for 120 seconds each, after injection of 5ml lidocaine 2% for each nerve. | Procedure or surgery | Radiofrequency |
Primary outcome
Postoperative Oxford Knee Score
Time frame: Three months post-operative
A difference of 5 points in Oxford Knee Score between groups will be considered significant. Range: 0 to 48, higher is better
Western Ontario and McMaster Universities Osteoarthritis Index postoperative
Time frame: 3 months postoperatively
A 12 point difference will be considered significant Range: 0 to 96, higher is better
4 secondary outcomes
Numerical rating scale pain postoperative
Time frame: Three months post-operatively
Chronic regional pain syndrome post-operatively
Time frame: 3 months post-operatively
Morphine consumption
Time frame: Three months post-operatively
Patient satisfaction
Time frame: Three months postoperatively
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 27 Jul 2026.
- Background: PubMed 17785736Murray DW, Fitzpatrick R, Rogers K, Pandit H, Beard DJ, Carr AJ, Dawson J. The use of the Oxford hip and knee scores. J Bone Joint Surg Br. 2007 Aug;89(8):1010-4. doi: 10.1302/0301-620X.89B8.19424.
- Background: PubMed 15208174Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.
- Background: PubMed 11501727Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001 Aug;45(4):384-91. doi: 10.1002/1529-0131(200108)45:43.0.CO;2-0.
- Background: PubMed 32711884Clement ND, Afzal I, Demetriou C, Deehan DJ, Field RE, Kader D. There is no clinically important difference in the Oxford knee scores between one and two years after total knee arthroplasty: The one-year score could be used as the benchmark timepoint to assess outcome. Knee. 2020 Aug;27(4):1212-1218. doi: 10.1016/j.knee.2020.05.015. Epub 2020 Jun 25.
- Background: PubMed 16360560Jordan K, Dunn KM, Lewis M, Croft P. A minimal clinically important difference was derived for the Roland-Morris Disability Questionnaire for low back pain. J Clin Epidemiol. 2006 Jan;59(1):45-52. doi: 10.1016/j.jclinepi.2005.03.018. Epub 2005 Nov 4.
- Background: PubMed 39640541Hasoon J, Orhurhu VJ, Yazdi C. Genicular Nerve Blocks for the Management of Chronic Knee Pain Related to Osteoarthritis - A Case Series. Orthop Rev (Pavia). 2024 Dec 3;16:126046. doi: 10.52965/001c.126046. eCollection 2024.
- Background: PubMed 36369781Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.
- Background: PubMed 18915634GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.
- Background: PubMed 35328153Fari G, de Sire A, Fallea C, Albano M, Grossi G, Bettoni E, Di Paolo S, Agostini F, Bernetti A, Puntillo F, Mariconda C. Efficacy of Radiofrequency as Therapy and Diagnostic Support in the Management of Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Feb 26;12(3):600. doi: 10.3390/diagnostics12030600.
- Background: PubMed 19647940Kvarstein G, Mawe L, Indahl A, Hol PK, Tennoe B, Digernes R, Stubhaug A, Tonnessen TI, Beivik H. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy--a 12-month follow-up. Pain. 2009 Oct;145(3):279-286. doi: 10.1016/j.pain.2009.05.001. Epub 2009 Aug 3.
- Background: PubMed 10515020van Kleef M, Barendse GA, Kessels A, Voets HM, Weber WE, de Lange S. Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain. Spine (Phila Pa 1976). 1999 Sep 15;24(18):1937-42. doi: 10.1097/00007632-199909150-00013.
- Background: PubMed 25530347Koh W, Choi SS, Karm MH, Suh JH, Leem JG, Lee JD, Kim YK, Shin J. Treatment of chronic lumbosacral radicular pain using adjuvant pulsed radiofrequency: a randomized controlled study. Pain Med. 2015 Mar;16(3):432-41. doi: 10.1111/pme.12624. Epub 2014 Dec 19.
- Individual participant dataSharing planned: Undecided
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.
Francesco Zuccarini, MD principal investigator
Iris South Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds in people with Total Knee Arthroplasty Secondary to Osteoarthritis and 18 Years and Older, run by Anesthesiology department Iris South Hospitals at 1 site in Belgium.
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 17 inclusion and 4 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 27 Jul 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 Belgium. 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 Stefano Doria, MD (+32492514178, sdoria@his-izz.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Oxford Knee Score (time frame: Three 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 NCT07727551, which also lists 22 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 27 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.