Cryoneurolysis for TKA - a Pilot Study

NCT05286996 | Unknown

• 1 other identifier: 22-iovera
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Total Knee Arthroplasty (TKA) is also known as a knee replacement. It is one of the most common orthopaedic (bone) surgeries performed and is usually very successful, but some people who have had a knee replacement feel pain that lasts for at least 3 months after surgery and thus continue to take pain control/ analgesic (opioids) medication. Opiates are medications like morphine. Pain post-surgery can make it difficult to recover and return to daily activities. A better control of pain before the surgery, can help people feel less pain, recover faster, and use less opioids after surgery. Cryoneurolysis means freezing the nerves that can cause pain. It uses very low temperatures in a specific body part (e.g., nerves to the knee) to freeze the pain nerves and therefore reduce the pain. When applied before the surgery it might help with postoperative pain after knee replacement. This study will evaluate Iovera, a cryoneurolysis handheld device commercially available in Canada that delivers freezing cold to a target nerve by using nitrous oxide. Cryoneurolysis can relieve pain and symptoms associated with osteoarthritis of the knee for up to 90 days.

Conditions

Knee Pain Chronic; Osteoarthritis

Keywords

total knee artroplasty; knee replacement

Outcome Measures

Primary Outcomes (1)

• Patient recruitment rate

  The primary objective of the pilot trial is to establish the feasibility of a larger definitive trial by successfully recruiting 20 patients over a 12-month period.

  12 months postoperative

Secondary Outcomes (5)

• Opioid consumption

  2 weeks postoperative

• Numeric Rating Scale of Pain

  2, 6 and 12 weeks postoperative

• Oxford Knee score

  6 and 12 weeks postoperative

• EQ-5D-5L

  6 and 12 weeks postoperative

• Quality of Recovery

  12 weeks postoperative

Study Arms (2)

Iovera

EXPERIMENTAL

Cryoneurolysis + standard of care: Usual intervention plus pre-operation Iovera treatment. Patients will receive local anaesthesia unilaterally to the affected knee prior to the treatment and then the anesthesiologist will administer the freezing cold therapy (Iovera device) to the affected knee.

Device: Iovera - Cryoneurolysis

Placebo

PLACEBO COMPARATOR

Placebo: Usual intervention plus pre-operation placebo. The placebo group will receive short-acting local anaesthesia injection unilaterally to the affected knee.

Drug: Local anesthetic

Interventions

Iovera - Cryoneurolysis DEVICE

Iovera system delivers precise, controlled doses of cold temperature only to the targeted nerve through a handheld device.

Iovera

Local anesthetic DRUG

Placebo - local anaesthesia

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients
• to 80 years of age
• Patients with radiographic confirmation and clinical correlation for severe osteoarthritis diagnosis with an indication for total knee replacement
• Patients undergoing primary unilateral total knee replacement
• No previous unilateral knee injection (steroids/biologics) within 6 months of study
• The patient is able to read and understand English and provide informed consent to participation in the study

You may not qualify if:

• Pregnancy and breastfeeding
• Cryoglobulinemia
• Paroxysmal cold hemoglobinuria
• Cold urticaria
• Raynaud's disease
• Current Opioid use
• History of opiate, narcotic and alcohol abuse
• Revision total knee replacement surgery
• Open and/or infected wounds at or near the affected knee

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

RECRUITING

Related Publications (7)

• Khan M, Osman K, Green G, Haddad FS. The epidemiology of failure in total knee arthroplasty: avoiding your next revision. Bone Joint J. 2016 Jan;98-B(1 Suppl A):105-12. doi: 10.1302/0301-620X.98B1.36293.

  PMID: 26733654 BACKGROUND

• Choi YJ, Ra HJ. Patient Satisfaction after Total Knee Arthroplasty. Knee Surg Relat Res. 2016 Mar;28(1):1-15. doi: 10.5792/ksrr.2016.28.1.1. Epub 2016 Feb 29.

  PMID: 26955608 BACKGROUND

• Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald D, Simpson AH, Howie CR. What determines patient satisfaction with surgery? A prospective cohort study of 4709 patients following total joint replacement. BMJ Open. 2013 Apr 9;3(4):e002525. doi: 10.1136/bmjopen-2012-002525. Print 2013.

  PMID: 23575998 BACKGROUND

• Wylde V, Hewlett S, Learmonth ID, Dieppe P. Persistent pain after joint replacement: prevalence, sensory qualities, and postoperative determinants. Pain. 2011 Mar;152(3):566-572. doi: 10.1016/j.pain.2010.11.023. Epub 2011 Jan 15.

  PMID: 21239114 BACKGROUND

• Zhou L, Kambin P, Casey KF, Bonner FJ, O'Brien E, Shao Z, Ou S. Mechanism research of cryoanalgesia. Neurol Res. 1995 Aug;17(4):307-11. doi: 10.1080/01616412.1995.11740333.

  PMID: 7477749 BACKGROUND

• Zhou L, Shao Z, Ou S. Cryoanalgesia: electrophysiology at different temperatures. Cryobiology. 2003 Feb;46(1):26-32. doi: 10.1016/s0011-2240(02)00160-8.

  PMID: 12623025 BACKGROUND

• Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.

  PMID: 28336454 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Luana Melo

CONTACT

4168646060; luana.melo@unityhealth.to

Amit Atrey

CONTACT

416- 864-5342; amit.atrey@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessors will be blinded about treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-randomized participant-blinded control trial

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 18, 2022
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)