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Efficacy and Safety of Cryoablation Compared with Cooled Radiofrequency Ablation of Genicular Nerves in Advanced Osteoarthritis of the Knee: A Study Protocol of Single-Centric, Assessor-Blinded, Randomized, Parallel-Group, Non-inferiority Study

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  • Musculoskeletal Interventions
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Abstract

Purpose

In patients with symptomatic osteoarthritis knee (OAK), cryoneurolysis (CRYO) and cooled radiofrequency ablation (C-RFA) are reported to be effective and safe; however, they have not been compared directly. The objective of this study is to compare CRYO and C-RFA of the genicular nerve (GN) in terms of efficacy and safety profile in patients with Kellgren and Lawrence (KL) grade ≥ 3 OAK.

Methods

This single-centric, assessor-blinded, randomized, parallel-group, non-inferiority study will include 80 patients with KL grade ≥ 3 OAK. The patients with ≥ 50% pain relief on diagnostic block of three GNs will be randomized to one of the two groups, i.e., CRYO (n = 40) or C-RFA (n = 40). The three target GNs for the interventions will include: superior medial, superior lateral, and inferior medial. The primary outcome will be efficacy of CRYO or C-RFA at 2, 12, and 24 weeks post-procedure based on the 11-point Numerical Pain Rating Scale. The secondary outcomes will be functional improvement based on 12-item Oxford Knee Score and safety of both the procedures. The study is registered in the Clinical Trials Registry—India.

Conclusion

CRYO and C-RFA provide pain relief and improve functional outcome by preventing transmission of pain signals, though by distinct mechanisms. While C-RFA is an established treatment modality, recent evidence supports CRYO in patients with OAK. This study intends to demonstrate non-inferiority of CRYO against C-RFA, thereby supporting the use of CRYO as an additional treatment modality in patients with KL grade ≥ 3 OAK.

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Author information

Authors and Affiliations

  1. Department of Pain Medicine, Daradia: The Pain Clinic, Kolkata, West Bengal, 700067, India

    Gautam Das & Sushpa Das

  2. Department of Anesthesia & Pain Medicine, JNMC, Wardha, Maharashtra, 442005, India

    Amol Singam & Vivek Chakole

  3. Department of Academic Research, Maverick Medicorum®, 601, Shiv Ganga Apartment, Beltarodi, Nagpur, Maharashtra, 440034, India

    Vikas Sharma

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  1. Gautam Das
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Correspondence to Vikas Sharma.

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Conflict of Interest

All authors declare that they have no conflict of interest.

Clinical Trial Registration

This study was registered in the Clinical Trials Registry—India (CTRI/2023/06/053646).

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For this protocol, consent for publication is not required.

Ethical Approval

This study was approved by the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India (DMIHER(DU)/IEC/2023/549).

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All procedures performed in studies involving human participants will be in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent will be obtained from all individual participants included in the study.

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Das, G., Singam, A., Chakole, V. et al. Efficacy and Safety of Cryoablation Compared with Cooled Radiofrequency Ablation of Genicular Nerves in Advanced Osteoarthritis of the Knee: A Study Protocol of Single-Centric, Assessor-Blinded, Randomized, Parallel-Group, Non-inferiority Study. Cardiovasc Intervent Radiol 47, 508–514 (2024). https://doi.org/10.1007/s00270-024-03703-2

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