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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
What is being tested?
Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds
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.

Stefano Doria, MD contact

+32492514178

sdoria@his-izz.be

Belgium1 site, 1 recruiting
  • Iris South Hospitals

    Brussels, 1050

    Stefano Doria, MD, +32492514178, sdoria@his-izz.be

    Recruiting

Other trials in Belgium

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 groups in NCT07727551
Study groupRoleWhat they receive
RadiofrequencyExperimentalPatients 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
ControlNo interventionPatients 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.

  1. 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

  2. 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)
  1. Numerical rating scale pain postoperative

    At effort and at rest. Range 0 to 10, higher is more pain (worse)

    Measured: Three months post-operatively

  2. 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

  3. Morphine consumption

    As evaluated by morphine equivalents

    Measured: Three months post-operatively

  4. 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.

  1. First posted27 Jul 2026
  2. Study start1 Jun 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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)
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 17785736
  • Tubach 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 15208174
  • Angst 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 11501727
  • Clement 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 32711884
  • Jordan 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 16360560
  • Hasoon 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 39640541
  • Shanahan 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 36369781
  • GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.

    PubMed 18915634
  • Fari 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 35328153
  • Kvarstein 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 19647940
  • van 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 10515020
  • Koh 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 25530347
  • Shanthanna 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 24453500
  • Li 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 38811979
  • Wylde 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

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.

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