Recruiting

Cryoneurolysis

Sponsor:

Unity Health Toronto

Code:

NCT05286996

Conditions

Knee Pain Chronic

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Iovera - Cryoneurolysis

Local anesthetic

Study Details

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

Study ID

NCT05286996

Start date

Dec 1, 2022

Status verified date

May, 2023

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Oct 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female patients
  • 18 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Iovera

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.

placebo comparator: Placebo

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

Interventions

Iovera - Cryoneurolysis

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

Local anesthetic

Placebo - local anaesthesia

Primary outcome measure

  • Patient recruitment rate [ Time Frame: 12 months postoperative ]

Central Contacts and Locations

Central contacts

Luana Melo

4168646060luana.melo@unityhealth.to

Amit Atrey

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

Locations

St Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

Principal Investigator:

Amit Atrey, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

May 12, 2023

Last verified

May, 2023

Keywords

  • total knee artroplasty
  • knee replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2023-05-12.