Cryoneurolysis Prior to Total Knee Arthroplasty

Summary

Knee osteoarthritis is a major issue worldwide with limited treatment options. Many patients receive knee joint replacement surgery which is considered effective and safe. Nonetheless the period post-surgery is characterized by moderate to severe pain inhibiting early ambulation, motivation and range of motion, compromising rehabilitation, patient satisfaction, and overall outcomes. An optimal strategy of postoperative pain treatment after knee replacement surgery has not yet been established.

Recently, our research center and others have shown that is possible to target the nerves surrounding the knee with a novel treatment called cryoneurolysis. Cryoneurolysis apply low temperatures \[-20°C ; -100°C\] to a target nerve, which disrupts nerve function and provides potential pain relief. This suggest a potential for cryoneurolysis to significantly improve rehabilitation, reduce opioid intake and overall outcomes after knee replacement surgery.

The primary objective of the current project is to determine the effectiveness of cryoneurolysis in its proposed ability to reduce opioid intake and postoperative pain after knee replacement surgery.

The study is a randomized controlled study with two groups. Group CRYO receives cryoneurolysis prior to knee replacement surgery and group SHAM receives a sham treatment prior to knee replacement surgery. Both groups receive surgery, analgesics and postoperative rehabilitation as per usual.

Efficacy of treatment is evaluated using the change in opioid intake in the CRYO group compared to the SHAM group 14 days after knee replacement surgery. Participants will also be assessed at 90 and 180 days after knee replacement surgery and will include measures on pain, quality of life and function.

Conditions

• Post Operative Pain
• Knee Osteoarthritis
• Opioid-Related Disorders

Interventions

DEVICE

Cryoneurolysis

The VISUAL-ICE uses a combination of argon and helium, to create a highly localized cold zone with temperatures between -20 and -100°C. A probe will be inserted percutaneously at the target AFCN and IBSN guided by ultrasound visualization to accurately determine the location of the nerve and to account for adjacent neurovascular structures and variations in anatomical structures. The target locations are drawn directly on the patients' skin prior to treatment along which a dose of local anesthetic will be injected subcutaneously before treatment. Cryoneurolysis at each target site requires 2 freeze cycles with a duration of 3 mins, and with thaw cycles between 20-40 seconds.

OTHER

Sham

A sham needles will be inserted percutaneously at the target AFCN and IBSN guided by ultrasound visualization. The target locations are drawn directly on the patients' skin prior to treatment along which a dose of local anesthetic will be injected subcutaneously before treatment. Sham will simulate cryoneurolysis at each target site for 2 freeze cycles with a duration of 3 mins, and also simulate thaw cycles between 20-40 seconds. No temperature changes will actually occur although the experience and sounds will be similar to cryoneurolysis

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Boston Scientific Corporation

  collaborator INDUSTRY

• Esbjerg Hospital - University Hospital of Southern Denmark

  lead OTHER

Principal Investigators

• Niels-Peter B Nygaard, PhD · Esbjerg Hospital - University Hospital of Southern Denmark

• Carsten Kock-Jensen, MD · Esbjerg Hospital - University Hospital of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-30

Primary Completion

2025-06-01

Completion

2026-03-01

FDA Device

Yes

Countries

• Denmark

Study Locations