Comparison of Conventional and Cooled Radiofrequency of the Genicular Nerves in Patients With Chronic Knee Pain

NCT05407610 | Recruiting

• 3 other identifiers: COGENIUSZ-2021109KCE20-1255
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 15

Brief Summary

Chronic knee pain remains a disabling disease despite current treatment strategies. There is an increase in the prevalence of osteoarthritis (OA) of the knee in the general population, presently affecting approximately 450,000 individuals in Belgium. A total knee replacement is a viable alternative for severe knee OA that does not respond to conservative therapy. Unfortunately, up to 53% of patients who undergo a total knee replacement develop persistent post-surgical pain (PPSP). There is currently no effective therapy for PPSP. A radiofrequency (RF) treatment applies high frequency current on the nerve responsible for pain conduction, resulting in an interruption of the transmission of pain. This can be applied to the nerves innervating the knee joint - the superolateral, superomedial and inferomedial genicular nerves - and could be an alternative, minimally invasive treatment for patients with knee OA who fail conservative treatments and for patients with PPSP. Data from the recent literature indicates that this treatment leads to a reduction of pain intensity and could result in an improvement of knee function, of the psychological state of the individual, and finally in an increase in health-related quality of life. Furthermore, RF of the genicular nerves could help avoid or delay a total knee replacement therefore potentially contributing to cost reduction. Both cooled and conventional RF treatments are reported in the literature to improve pain. The use of water to cool the RF electrodes results in an increased lesion size by removing heat from adjacent tissue, allowing power delivery to be increased. As a consequence, cooled RF could result in a higher chance of success and longer duration of effect. Until now, the studies performed on cooled RF are industry initiated and a direct comparison between conventional, cooled and a sham procedure is lacking. The aim of the COGENIUS trial is to investigate the effect of the two types of RF treatment on individuals experiencing chronic knee pain that is resistant to conservative treatments. For this purpose, the efficacy and cost-effectiveness of cooled and conventional RF will be compared to a sham procedure in patients suffering from knee OA and PPSP after total knee replacement.

Conditions

Knee Osteoarthritis; Persistent Postsurgical Pain; Chronic Knee Pain

Keywords

Osteoarthritis; Persistent Postsurgical Pain; Knee; Radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months post-intervention

  The primary endpoint is the WOMAC score (range 0-96) at 6 months post-intervention. The WOMAC score is derived from a self-administered osteoarthritis-specific validated questionnaire on pain, stiffness, and physical functioning of the knee joint.The lower the score, the lower the osteoarthritis-specific symptoms are.

  6 months post-intervention.

Secondary Outcomes (16)

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

  1-, 3-, 6-, 12- and 24-months post-intervention.

• Pain Intentisty

  1-, 3-, 6-, 12- and 24-months post-intervention.

• The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS)

  1-, 3-, 6-, 12- and 24-months post-intervention.

• Health-related quality of life

  1-, 3-, 6-, 9-, 12- and 24-months post-intervention.

• Goniometry

  1-, 3-, 6-, 12- and 24-months post-intervention.

Other Outcomes (2)

• Phenotype of patients suffering from Persistent Post-Surgical Pain (PPSP)

  Baseline

• Time to additional interventions

  Follow-up until 24-months post- intervention.

Study Arms (3)

Conventional Radiofrequency of the genicular nerves

ACTIVE COMPARATOR

In the conventional radiofrequency group a intervention of 80°C at the tip is applied during 90 seconds at each nerve (superolateral, superomedial and inferomedial genicular nerves). The probe stays in place for 150 seconds at each nerve so that the time needed for each procedure is similar.

Procedure: Conventional Radiofrequency ablation of the genicular nerves

Cooled Radiofrequency of the genicular nerves

ACTIVE COMPARATOR

In the cooled radiofrequency group a intervention of 60°C measured at the tip and on average 80°C in the targeted tissue is applied for 150 seconds using the Cooled RF system at each nerve (superolateral, superomedial and inferomedial genicular nerves).

Procedure: Cooled Radiofrequency ablation of the genicular nerves

Sham procedure

SHAM COMPARATOR

In the sham group a 18 gauge introducer and probe will be placed but no RF intervention will be applied. The generator will be turned on without connection to the probe for 150 seconds and the sound of the generator will be mimicked with a recording. The position of the needle will not be checked by fluoroscopy; however, the intervention team will position the fluoroscopy arm and mention the acquisition of the fluoroscopic image to the patient. This way no unnecessary radiation is used.

Procedure: Sham procedure

Interventions

Conventional Radiofrequency ablation of the genicular nerves PROCEDURE

Conventional Radiofrequency treatment of the genicular nerves of the knee blocks the transmission of painful stimuli from the sensory genicular nerves of the knee to the central nervous system by means of a thermal lesion created using RF current.

Also known as: Conventional Radiofrequency ablation

Conventional Radiofrequency of the genicular nerves

Cooled Radiofrequency ablation of the genicular nerves PROCEDURE

Cooled RF treatment causes a larger lesion size compared to conventional RF by means of internal cooling of the probe.

Also known as: Cooled Radiofrequency ablation

Cooled Radiofrequency of the genicular nerves

Sham procedure PROCEDURE

Sham procedure with placing of needles subcutaneously.

Sham procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent must be obtained before any study assessment is performed.
• Adult patients (Age ≥ 18 years old).
• Chronic anterior knee pain (\> 12 months) that is moderate to severe (defined as NRS \> 4 on most or all days for the index knee either constantly or with motion at time of screening and, an average NRS score reported in the patient diary \>4 at the end of the run-in period).
• Only for patients with Osteoarthritis (OA): Radiologic confirmation of knee osteoarthritis of grade 2 (mild), 3 (moderate) or 4 (severe) noted within 12 months prior to the screening for the index knee according the Kellgren Lawrence criteria diagnosed by an independent radiologist with experience in musculoskeletal imaging on radiography (Rx) or magnetic resonance imaging (MRI). If imaging will need to be performed at screening it is recommended to perform an MRI instead of Rx. Imaging with MRI will enable the independent radiologist to perform a better estimation of the grade of OA.
• Only for patients with Persistent Post-Surgical Pain (PPSP) after Total Knee Arthroplasty (TKA): Patients with PPSP\* after TKA need to have had a negative orthopaedic work-up

You may not qualify if:

• Local or systemic infection (bacteraemia).
• Evidence of inflammatory arthritis or an inflammatory systemic disease responsible for knee pain.
• Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, ...) in the index knee during the 3 months prior to procedure.
• Pregnant, nursing or planning to become pregnant before the study intervention. Participants who become pregnant after the study intervention during the follow-up period will not be excluded.
• Chronic widespread pain.
• Patients with unstable psychosocial disorder.
• Allergies to products used during the procedure (lidocaine, propofol, chlorhexidine).
• Uncontrolled coagulopathy defined as supratherapeutic dose of anticoagulation medication.
• Uncontrolled immune suppression.
• Participating in another clinical trial/investigation within 30 days prior to signing informed consent.
• Patient is currently implanted with a neurostimulator.
• Current radicular pain in index leg.
• Previous conventional or cooled radiofrequency of the index knee.
• Patients who have a planned TKA in the near future defined as patients who already have agreed on a date for the TKA procedure.
• Patients who are unwilling or mentally incapable to complete the study questionnaires.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• Belgium Health Care Knowledge Centre: collaborator
• Klinische Epidemiologie en Medical Technology Assessment: collaborator

Study Sites (15)

UZ Antwerpen

Antwerp, 2650, Belgium

RECRUITING

AZ Klina

Brasschaat, 2930, Belgium

ACTIVE NOT RECRUITING

ULB Erasme

Brussels, 1070, Belgium

RECRUITING

UCL Saint-Luc

Brussels, 1200, Belgium

ACTIVE NOT RECRUITING

Ziekenhuis Oost-Limburg AV

Genk, 3600, Belgium

RECRUITING

AZ Maria Middelares

Ghent, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

AZ Groeninge

Kortrijk, 8500, Belgium

ACTIVE NOT RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

CHR de la Citadelle

Liège, 4000, Belgium

RECRUITING

CHU Liège

Liège, 4000, Belgium

ACTIVE NOT RECRUITING

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

AZ Turnhout

Turnhout, 2300, Belgium

RECRUITING

Rijnstate

Arnhem, 6815 AD, Netherlands

ACTIVE NOT RECRUITING

MUMC

Maastricht, 6229 HX, Netherlands

RECRUITING

Related Publications (1)

• Vanneste T, Belba A, van Kuijk S, Kimman M, Bellemans J, Bonhomme V, Sommer M, Emans P, Vankrunkelsven P, Tartaglia K, Van Zundert J. Comparison of conventional and cooled radiofrequency treatment of the genicular nerves versus sham procedure for patients with chronic knee pain: protocol for a multicentre, double-blind, randomised controlled trial (COGENIUS). BMJ Open. 2023 Aug 2;13(8):e073949. doi: 10.1136/bmjopen-2023-073949.

  PMID: 37532482 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Jan Van Zundert

CONTACT

+32 (0)89 32.52.54; cogenius@zol.be

Charlotte Claes

CONTACT

+32 (0)89 21.20.85; cogenius@zol.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three-arm, pragmatic, prospective, multicentre, double blind, randomised sham-controlled trial

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: July 7, 2022
• Primary Completion: March 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Considering that ongoing research contributing to the completion of datasets must not be compromised by premature or opportunistic sharing and analysis of data, ZOL will not release the data of its studies until the primary study results have been published, unless authorized for release has been granted.

Locations

NL (2); BE (13)