NCT06594003

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2024Nov 2026

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 10, 2024

Last Update Submit

September 10, 2024

Conditions

Keywords

kneeosteoarthritisradiofrequencygenicular nerves

Outcome Measures

Primary Outcomes (1)

  • vas score

    will be assessed at 0, 1, and 4 weeks. on the Visual Analogue Scale (VAS) (0 = no pain, 10 = unbearable pain).

    4 weeks

Secondary Outcomes (4)

  • Total WOMAC score.

    4 weeks

  • seven-point Likert scale

    4 weeks

  • analgesic request

    4 weeks

  • adverse effects

    4 weeks

Study Arms (2)

three genicular nerves raiofrequency ablation

ACTIVE COMPARATOR
Procedure: Radiofrequency

eight genicular nerves radiofrequency ablation

ACTIVE COMPARATOR
Procedure: Radiofrequency

Interventions

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 ablationthree genicular nerves raiofrequency ablation

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine

Asyut, Egypt

Location

Related Publications (11)

  • 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.

    PMID: 38929474BACKGROUND
  • 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.

    PMID: 31257831BACKGROUND
  • 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.

    PMID: 28835778BACKGROUND
  • 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.

    PMID: 31333900BACKGROUND
  • 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.

    PMID: 38155108BACKGROUND
  • 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.

    PMID: 37745043BACKGROUND
  • 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.

    PMID: 33801304BACKGROUND
  • 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.

    PMID: 32722615BACKGROUND
  • 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.

    PMID: 35686229BACKGROUND
  • 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.

    PMID: 37615856BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Amal Ibrahim Amal Ibrahim Mubarak, assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations