Motor Sparing Techniques, Genicular Nerve Radiofrequency Ablation Has Emerged As a Viable Alternative to Conservative Therapy and Total Knee Arthroplasty

NCT ID: NCT06594003

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-11-01

Brief Summary

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There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves (11, 12). Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support

Detailed Description

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Knee pain is a common issue in adults, with a steadily increasing prevalence (1). There are many causes of knee pain, such as meniscal and tendon injuries, posttraumatic syndrome, and postsurgical pain; osteoarthritis is the leading cause (2).

Knee osteoarthrosis (KOA) is a very common joint disease, with a prevalence ranging from 4.2% to 15.5% and gradually increasing with age (3). It is associated with diverse causes including age, obesity, metabolic bone diseases, and acute or chronic joint injuries. Pain and disabilities are the major consequences of KOA, with 25% of patients suffering from severe arthralgia. KOA is believed to be a result of the failure of chondrocytes to maintain homeostasis between the synthesis and degradation of the extracellular matrix and from subchondral bone developing osteoarthrosis (4, 5).

Although traditional treatment modalities, including analgesics, physical therapy, and intra-articular steroid (IAS) injections, have long been employed to manage symptoms, the growing need for more effective and minimally invasive interventions has prompted the exploration of novel approaches (6).

Among these newer treatments, motor sparing techniques, genicular nerve radiofrequency ablation has emerged as a viable alternative to conservative therapy and total knee arthroplasty (7).

Genicular nerve ablation is a known procedure to help these cases as they transfer the pain signal of the knee. It is usually reserved for patients with symptomatic knee osteoarthritis who have had failure of conservative treatment and have had failure of or are poor candidates for surgery (8).

However, there is a high failure rate among the patients undergoing the procedure as regarding the efficacy or the duration of pain relief and various methods have been used to increase the rate of success and the duration of the pain relief such as using alcohol in the ablation, cooled radiofrequency or increase the lesions on the nerves (9, 10).

There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves (11, 12). Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support (13).

Conditions

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Knee Osteoarthritis \(OA\)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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three genicular nerves raiofrequency ablation

Group Type ACTIVE_COMPARATOR

Radiofrequency

Intervention Type PROCEDURE

There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves . Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support

eight genicular nerves radiofrequency ablation

Group Type ACTIVE_COMPARATOR

Radiofrequency

Intervention Type PROCEDURE

There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves . Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support

Interventions

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Radiofrequency

There has recently been considerable interest in the role of radiofrequency ablation (RFA) of the genicular nerves for KOA. In the majority of previous studies, ablation was done via a radiofrequency technique using either fluoroscopy or ultrasound for only three genicular nerves, whereas the knee joint is also supplied by a few other nerves . Interestingly, neurolytic agents can also be used to ablate the nerves, and are readily available, less costly, and need less logistic support

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age from 50-70 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Patients with 3rd and 4th degree of KOA pain who undergo knee articular branch denervation via RF ablation.

Exclusion Criteria

* Deformities in knee.
* Charcot joint (stiff Joint)
* Acute knee injury
* Previous ipsilateral total knee arthroplasty or radiofrequency denervation.
* Instability of knee Joint.
* Knee effusion \& Baker's cyst . . Inability to assume a recumbent or semirecumbent position.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amal Ibrahim Mubarak

teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Amal Ibrahim Amal Ibrahim Mubarak, assistant lecturer

Role: CONTACT

01067820046 ext. +2

References

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Kwon HJ, Kim CS, Kim DH, Shin JW, Choi D, Choi SS. Effectiveness of the Cooled Radiofrequency Ablation of Genicular Nerves in Patients with Chronic Knee Pain Due to Osteoarthritis: A Double-Blind, Randomized, Controlled Study. Medicina (Kaunas). 2024 May 24;60(6):857. doi: 10.3390/medicina60060857.

Reference Type BACKGROUND
PMID: 38929474 (View on PubMed)

Dass RM, Kim E, Kim HK, Lee JY, Lee HJ, Rhee SJ. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain. 2019 Jul 1;32(3):223-227. doi: 10.3344/kjp.2019.32.3.223.

Reference Type BACKGROUND
PMID: 31257831 (View on PubMed)

Wehling P, Evans C, Wehling J, Maixner W. Effectiveness of intra-articular therapies in osteoarthritis: a literature review. Ther Adv Musculoskelet Dis. 2017 Aug;9(8):183-196. doi: 10.1177/1759720X17712695. Epub 2017 Jun 20.

Reference Type BACKGROUND
PMID: 28835778 (View on PubMed)

Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.

Reference Type BACKGROUND
PMID: 31333900 (View on PubMed)

Karm MH, Kwon HJ, Kim CS, Kim DH, Shin JW, Choi SS. Cooled radiofrequency ablation of genicular nerves for knee osteoarthritis. Korean J Pain. 2024 Jan 1;37(1):13-25. doi: 10.3344/kjp.23344.

Reference Type BACKGROUND
PMID: 38155108 (View on PubMed)

Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.

Reference Type BACKGROUND
PMID: 37745043 (View on PubMed)

Primorac D, Molnar V, Matisic V, Hudetz D, Jelec Z, Rod E, Cukelj F, Vidovic D, Vrdoljak T, Dobricic B, Anticevic D, Smolic M, Miskulin M, Cacic D, Boric I. Comprehensive Review of Knee Osteoarthritis Pharmacological Treatment and the Latest Professional Societies' Guidelines. Pharmaceuticals (Basel). 2021 Mar 2;14(3):205. doi: 10.3390/ph14030205.

Reference Type BACKGROUND
PMID: 33801304 (View on PubMed)

Primorac D, Molnar V, Rod E, Jelec Z, Cukelj F, Matisic V, Vrdoljak T, Hudetz D, Hajsok H, Boric I. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020 Jul 26;11(8):854. doi: 10.3390/genes11080854.

Reference Type BACKGROUND
PMID: 32722615 (View on PubMed)

Ng TK, Lam KHS, Allam AE. Motor-Sparing Neural Ablation with Modified Techniques for Knee Pain: Case Series on Knee Osteoarthritis and Updated Review of the Underlying Anatomy and Available Techniques. Biomed Res Int. 2022 May 31;2022:2685898. doi: 10.1155/2022/2685898. eCollection 2022.

Reference Type BACKGROUND
PMID: 35686229 (View on PubMed)

Leite CBG, Merkely G, Charles JF, Lattermann C. From Inflammation to Resolution: Specialized Pro-resolving Mediators in Posttraumatic Osteoarthritis. Curr Osteoporos Rep. 2023 Dec;21(6):758-770. doi: 10.1007/s11914-023-00817-3. Epub 2023 Aug 24.

Reference Type BACKGROUND
PMID: 37615856 (View on PubMed)

1. Байбусунова А, Нысанбай Г, Шварц Д, Жакеева М. Diagnosis and treatment of knee osteoarthritis: Modern aspects. J Orthop Trauma. 2024;48(12):21-9.

Reference Type BACKGROUND

Other Identifiers

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genicular nerves ablation

Identifier Type: -

Identifier Source: org_study_id

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