Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Comparison of conventional and cooled radiofrequency treatment of the genicular nerves versus sham procedure for patients with chronic knee pain: a multicentre, double blind, randomised controlled trial - COGENIUS |
|
Participants (P) |
The study population consists of two separate patient populations, patients with chronic knee pain due to therapy resistant osteoarthritis of the knee (OA) or persistent post-surgical knee pain (PPSP) after total knee arthroplasty. |
|
Intervention (I) |
There are two intervention groups: cooled and conventional radiofrequency (RF) treatment of the superolateral, superomedial and inferomedial genicular nerves. |
|
Control (C) |
A sham procedure with placement of three needles in the subcutaneous area of the superolateral, superomedial and inferomedial genicular nerves with injection of local anaesthetic which will mimic the intervention(s) mentioned above. |
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Outcome (O) |
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (range 0-96) at 6 months post treatment. The comparison of the three groups will happen for the primary endpoint cross-sectionally at 6 months. |
|
Trial Design |
A prospective, multicentre, double blind, randomised controlled pragmatic trial with three study groups with a 2:2:1 randomisation ratio |
|
Sample Size |
200 OA and 200 PPSP patients making a total of 400 patients |
|
Trial duration |
Approximately 57 months |
|
Budget |
2,395,000 € |
Trial team
|
Sponsor |
Ziekenhuis Oost-Limburg |
|
Chief Investigator |
Prof. Dr. Jan van Zundert |
|
External Partners |
KEMTA |
| Number of Participing Sites |
20 sites total: 18 sites from Flanders, Brussels and Wallonia and with the participation of 2 Dutch sites |
DOCUMENTS
REFERENCES
Clinicaltrials.gov: NCT05407610
Website: Cogenius study
