Cryoneurolysis Prior to Total Knee Arthroplasty

NCT05840276 | Active Not Recruiting FDA Device

• 1 other identifier: Cryo_tka
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Opioids

  Oral morphine intake after total knee arthroplasty in CRYO compared to SHAM

  14 days after total knee arthroplasty

Secondary Outcomes (9)

• Pain scores on the visual analogue scale

  14, 90 and 180 days after total knee arthroplasty

• Adverse effects

  14, 90 and 180 days after total knee arthroplasty

• Opioid-related adverse effects

  14, 90 and 180 days after total knee arthroplasty

• Pain and Function

  90 and 180 days after total knee arthroplasty

• Quality of Life using SF-36

  90 and 180 days after total knee arthroplasty

Study Arms (2)

CRYO

EXPERIMENTAL

Receives cryoneurolysis treatment on the anterior femoral cutanous nerve and the infrapatellar branch of the saphenous nerve.

Device: Cryoneurolysis

SHAM

SHAM COMPARATOR

Receives similar procedures as in CRYO but with no freezing temperatures.

Other: Sham

Interventions

Cryoneurolysis DEVICE

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.

Also known as: Cryoanalgesia, Cryoneuroablation, Cryoablation

CRYO

Sham OTHER

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

SHAM

Eligibility Criteria

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

You may qualify if:

• Scheduled for unilateral, primary total knee arthroplasty
• Age ≥ 18y
• Written and oral understanding of Danish.

You may not qualify if:

• Contraindications against ibuprofen or paracetamol, for example previous gastric ulcer, or known renal failure (eGRF \< 60 ml/kg/1,73m2), known thrombocytopenia (\< 100 bil/l); or against treatment with morphine
• History of neuropathic pain
• Previous recipient of cryoneurolysis for the knee
• Patients with daily use of high dose opioid (\> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids
• Uncontrolled serious disease (cancer, diabetes, etc.)
• Disease associated with reactions to cold, such as cryoglobulinemia, cold urticarial and Reynaud's syndrome.

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Odense University Hospital: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

Hospital of Southwest Jutland

Esbjerg, Region Syddanmark, 6700, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Knee; Opioid-Related Disorders

Interventions

Cryosurgery; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Niels-Peter B Nygaard, PhD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Carsten Kock-Jensen, MD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: August 30, 2023
• Primary Completion: June 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after completion and publication of the study results.
• Access Criteria: Data must adhere to the Danish Data Protection Agency and must be handled according to the General Data Protection Regulation (GDPR) and the Danish Data Protection Act.

Locations

DK (1)