Cryoneurolysis Prior to Total Knee Arthroplasty for the Management of Postoperative Pain; A Randomized, Sham-controlled, Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Scheduled for unilateral, primary total knee arthroplasty

• Age ≥ 18y

• Written and oral understanding of Danish.

Locations
Other Locations
Denmark
Hospital of Southwest Jutland
RECRUITING
Esbjerg
Contact Information
Primary
Niels-Peter B Nygaard, PhD
niels-peter.brochner.nygaard@rsyd.dk
DK+20612033
Backup
Carsten Kock-Jensen, MD
carsten.kock-jensen@rsyd.dk
Time Frame
Start Date: 2023-08-30
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 100
Treatments
Experimental: CRYO
Receives cryoneurolysis treatment on the anterior femoral cutanous nerve and the infrapatellar branch of the saphenous nerve.
Sham_comparator: SHAM
Receives similar procedures as in CRYO but with no freezing temperatures.
Sponsors
Collaborators: Boston Scientific Corporation, Odense University Hospital
Leads: Esbjerg Hospital - University Hospital of Southern Denmark

This content was sourced from clinicaltrials.gov