Short summary

This single-center, randomized controlled trial evaluates the efficacy of cryoneurolysis in patients undergoing total knee arthroplasty (TKA). Participants are randomized into a cryoneurolysis or sham group, and will be assessed at various intervals post-TKA. The main outcome is opioid consumption post-operation, with secondary outcomes including pain scores and adverse effects.

Rationale

Chronic pain, especially from osteoarthritis, is a global challenge. In Europe, 20% of chronic pain is linked to osteoarthritis. Current treatments offer limited relief and can have side effects. Total knee arthroplasty (TKA) is an effective solution, but post-surgery pain impacts recovery. Over 20% still experience pain post-surgery. Cryoneurolysis is an emerging solution that targets nerves, disrupting their function but allowing regeneration. It's shown promise in reducing hospital stays and pain post-TKA. This study aims to determine cryoneurolysis's effectiveness in reducing opioid use and postoperative pain after TKA, and its impact on functional performance and patient satisfaction.

Description of the cohort

The study includes patients scheduled for unilateral, primary total knee arthroplasty at the department of orthophedics, University Hospital of Southern Denmark, Esbjerg / Grindsted Hospital.

Data and biological material

Primary outcome measures • Oral morphine intake during the first 14 after the operation Secondary outcome measures • Pain score measured in VAS during the first 14 days after the operation • Adverse effects from cryoneurolysis • Opioid-related adverse effects Exploratory outcomes • Functional performance, evaluated by the 30 second chair-stand test, the 40m fast-paced walk test, the 9 step stair test and Maximum Voluntary Contraction (MVC) force • Pain score measured in VAS • PRO-data specifically designed to evaluate patients with knee pain (knee oxford score) • Health-related quality of life using the SF-36 questionnaire. • Range of motion via Copenhagen Knee Rom Scale • Socioeconomic indicators including patient satisfaction, readmission rate • Pain catastrophizing

Collaborating researchers and departments

Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense

• Martin Lindberg-Larsen

Department of Neurology, University Hospital of Southern Denmark, Esbjerg / Grindsted Hospital

• Carsten Kock-Jensen

Department of Orthopedics, University Hospital of Southern Denmark, Esbjerg / Grindsted Hospital

• Didde Christiansen
• Lars Lykke Hermansen

Publications associated with the project

Nygaard, N. B. et al. Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial. BMC Musculoskelet Disord 22, 228, doi:10.1186/s12891-021-04102-1 (2021).