Preoperative Genicular Radiofrequency and Functional Outcomes After Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAnesthesiology department Iris South Hospitals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 60
Elective total knee arthroplasty
2 to 6 weeks before the procedure
BMI > 35
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds
Procedure/SurgeryRadiofrequency 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: RadiofrequencyExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
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
Time frame
Three months post-operative2
Western Ontario and McMaster Universities Osteoarthritis Index postoperative
A 12 point difference will be considered significant Range: 0 to 96, higher is better
Time frame
3 months postoperativelySecondary outcomes
1
Numerical rating scale pain postoperative
At effort and at rest. Range 0 to 10, higher is more pain (worse)
Time frame
Three months post-operatively2
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
Time frame
3 months post-operatively3
Morphine consumption
As evaluated by morphine equivalents
Time frame
Three months post-operatively4
Patient satisfaction
11 point Likert scale, higher is better
Time frame
Three months postoperativelySponsors and contacts
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Source ClinicalTrials.gov