Preoperative Genicular Radiofrequency and Functional Outcomes After Total Knee Arthroplasty

NCT07727551 | Recruiting

• 1 other identifier: CEHIS2026/05
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Total Knee Arthroplasty Secondary to Osteoarthritis; 18 Years and Older

Keywords

Radiofrequency ablation; Genicular nerve

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 months postoperatively

Secondary Outcomes (4)

• Numerical rating scale pain postoperative

  Three months post-operatively

• Chronic regional pain syndrome post-operatively

  3 months post-operatively

• Morphine consumption

  Three months post-operatively

• Patient satisfaction

  Three months postoperatively

Study Arms (2)

Radiofrequency

EXPERIMENTAL

Patients in this arm will receive genicular nerve radiofrequency ablation between 2 to 6 weeks before undergoing elective total knee replacement

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

Interventions

Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds PROCEDURE

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.

Radiofrequency

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60
• Elective total knee arthroplasty
• to 6 weeks before the procedure
• AND either of:
• BMI \> 35
• Diabetes under insulin
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anesthesiology department Iris South Hospitals: lead

Study Sites (1)

Iris South Hospitals

Brussels, 1050, Belgium

RECRUITING

Related Publications (22)

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Study Officials

• Francesco Zuccarini, MD

  Iris South Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Doria, MD

CONTACT

+32492514178; sdoria@his-izz.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

BE (1)