Hip ArthropathyNCT06942078
Cryoneurolysis in Patients Awaiting Total Hip and Knee Arthroplasty
A study testing Cryoneurolysis in people with Hip Arthropathy and Knee Arthropathy, run by University of Calgary.
Trial summary
During the COVID-19 pandemic, there was a drastic increase in surgical wait times across Canada, notably for patients awaiting total knee and hip arthroplasty. Currently the average wait time for total hip arthroplasty (THA) in Alberta is 16 weeks with the 90th percentile of wait times being 47 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy, Knee Arthropathy
- What is being tested?
- Cryoneurolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently awaiting THA or TKA (have signed consent for surgery)
- Osteoarthritis as a primary diagnosis for THA or TKA
- Currently taking regular daily opioids for at least one month
- No allergies to local aesthetics
- Speaks and understands English
- Over 18 years old
- Lives within a 1-hour distance of the hospital where the study is taking place or willing to travel to the hospital for the interventions and follow up.
Who cannot join
- If surgery is expected to be completed within 1 month of the intervention as this would limit our ability to evaluate the effectiveness of the cryoneurolysis procedure
- Allergies to local anesthetics
- Inability to communicate with investigators
- Opioid use disorder
- History of severe psychiatric or medical conditions which hinder effective communication
- Living more than 1 hour away from the hospital where the study is taking place or unable to travel to the hospital for the interventions and follow up
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- Body mass Index (BMI) ≥40
- Any contraindications specific to percutaneous cryoneurolysis such as history of bleeding diathesis, any active infections at the procedural site, cold urticaria, cryofibrinogenemia, cryoglobulinemia, paroxysmal cold hemoglobinuria, or Raynaud's disease (see Ilfeld \& Finneran, 2020)
- Use of therapeutic anticoagulation
- Diagnosis of Non-Osteoarthritis as the cause for THA or TKA
- Other chronic pain condition which patients may be taking opioids to control the pain (e.g. Fibromyalgia or Complex Regional Pain Syndrome)
- Less than 50% reduction in pain with diagnostic blocks using 0.5% bupivacaine
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cryoneurolysis as an Interim Pain Control Strategy in Patients Awaiting Total Hip and Knee Arthroplasty: a Prospective Observational Study
During the COVID-19 pandemic, there was a drastic increase in surgical wait times across Canada, notably for patients awaiting total knee and hip arthroplasty. Currently the average wait time for total hip arthroplasty (THA) in Alberta is 16 weeks with the 90th percentile of wait times being 47 weeks. The average wait for total knee arthroplasty (TKA) in Alberta is 20 weeks with the 90th percentile of wait times being 60 weeks. As the waitlist for these surgeries grows and with limited resources to increase the number of surgeries being performed, there is a critical need for strategies to manage the pain experienced by patients during these long waiting periods.
Many patients awaiting surgery are placed onto long-term opioid therapy to manage their pain. There are, however, significant risks associated with the extended use of opioids for pain management, such as addiction, opioid abuse, increased risk of overdose, increased risk of fractures, and increased risk of adverse cardiac events. Recognizing these risks, different strategies need to be employed to attempt to minimize the opioid burden faced by those waiting for surgery. One potential strategy is to utilize regional anesthesia for analgesia rather than relying on opioids. Regional anesthesia with nerve blocks using local anesthetic has been used in the management of preoperative pain for patients awaiting surgery for hip fracture and has been shown to be effective in reducing pain, opioid use, and the risk of serious adverse effects. However, for patients with hip fractures, their surgery usually occurs within 36 hours due to significant risks which occur beyond that timeframe. For patients waiting for THA and TKA, the surgical wait time could be weeks to months. Providing daily nerve blocks or even weekly catheters for an individual waiting up to a year for surgery is not sustainable and carries significant risks with repeated injections. New regional anesthesia techniques lasting a longer period of time are needed.
One promising intervention is to utilize cryoneurolysis. Cryoneurolysis involves treating targeted nerves using extremely low temperatures. This disrupts nerve conduction and pain impulses. Importantly, connective tissue components of the nerve are left intact allowing for regeneration over time. Because of this, cryoneurolysis is a well-established treatment for chronic and acute pain due to its effectiveness and low risk safety profile. While cryoneurolysis is well-established in its use treating chronic and surgical pain, one limitation is that it is focused primarily on postoperative pain. Our study intends to primarily evaluate the efficacy of cryoneurolysis as a preoperative pain management intervention. Establishing the use of cryoneurolysis for preoperative pain will provide a valuable resource for reducing the pain patients experience while awaiting surgery, leading to decreased opioid use and improved overall well-being. The investigators will be recruiting 30 participants total (15 having TKA and 15 having THA) that will be given cryoneurolysis while waiting for their surgery.
- Conditions
- Hip Arthropathy, Knee Arthropathy
- Being tested
- Cryoneurolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisProcedure or surgery
Targeting of specific nerves related to surgical procedure using very low temperatures
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolysis | Experimental | Participants will receive a diagnostic nerve block with local anesthetic. This block will be performed on nerves that supply the hip joint or knee joint depending on location of osteoarthritis. If pain relief is greater than 50%, cryoneurolysis will be performed targeting nerves that supply the hip or knee joint with very low temperatures. Receives: Procedure: Cryoneurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Morphine Equivalent Consumption
Daily Oral Morphine Equivalent Consumption
Measured: Pre-intervention, 2-weeks, 4-weeks, 8-weeks, 6 months, and 1-year post-intervention; 2-weeks, 6-weeks, 12-weeks postoperative
Secondary outcomes (3)
NRS Pain Score
Numerical Rating Scale Pain Score
Measured: Pre-intervention, 2-weeks, 4-weeks, 8-weeks, 6 months, and 1-year post-intervention; 2-weeks, 6-weeks, 12-weeks postoperative
EQ-5D Score
EuroQol 5-Dimension Score
Measured: Pre-intervention, 2-weeks, 4-weeks, 8-weeks, 6 months, and 1-year post-intervention; 2-weeks, 6-weeks, 12-weeks postoperative
WOMAC Score
Western Ontario and McMaster Universities Osteoarthritis Index Score
Measured: Pre-intervention, 2-weeks, 4-weeks, 8-weeks, 6 months, and 1-year post-intervention; 2-weeks, 6-weeks, 12-weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Endersby, University of Calgary
- Investigators
- Ryan Endersby, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942078
- Sponsor's protocol ID
- REB25-0319
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoneurolysis as an Interim Pain Control Strategy in Patients Awaiting Total Hip and Knee Arthroplasty: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06942078
- Acronym / sponsor ID
- REB25-0319
- Conditions
- Hip Arthropathy, Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the COVID-19 pandemic, there was a drastic increase in surgical wait times across Canada, notably for patients awaiting total knee and hip arthroplasty. Currently the average wait time for total hip arthroplasty (THA) in Alberta is 16 weeks with the 90th percentile of wait times being 47 weeks. The average wait for total knee arthroplasty (TKA) in Alberta is 20 weeks with the 90th percentile of wait times being 60 weeks. As the waitlist for these surgeries grows and with limited resources to increase the number of surgeries being performed, there is a critical need for strategies to manage the pain experienced by patients during these long waiting periods.
Many patients awaiting surgery are placed onto long-term opioid therapy to manage their pain. There are, however, significant risks associated with the extended use of opioids for pain management, such as addiction, opioid abuse, increased risk of overdose, increased risk of fractures, and increased risk of adverse cardiac events. Recognizing these risks, different strategies need to be employed to attempt to minimize the opioid burden faced by those waiting for surgery. One potential strategy is to utilize regional anesthesia for analgesia rather than relying on opioids. Regional anesthesia with nerve blocks using local anesthetic has been used in the management of preoperative pain for patients awaiting surgery for hip fracture and has been shown to be effective in reducing pain, opioid use, and the risk of serious adverse effects. However, for patients with hip fractures, their surgery usually occurs within 36 hours due to significant risks which occur beyond that timeframe. For patients waiting for THA and TKA, the surgical wait time could be weeks to months. Providing daily nerve blocks or even weekly catheters for an individual waiting up to a year for surgery is not sustainable and carries significant risks with repeated injections. New regional anesthesia techniques lasting a longer period of time are needed.
One promising intervention is to utilize cryoneurolysis. Cryoneurolysis involves treating targeted nerves using extremely low temperatures. This disrupts nerve conduction and pain impulses. Importantly, connective tissue components of the nerve are left intact allowing for regeneration over time. Because of this, cryoneurolysis is a well-established treatment for chronic and acute pain due to its effectiveness and low risk safety profile. While cryoneurolysis is well-established in its use treating chronic and surgical pain, one limitation is that it is focused primarily on postoperative pain. Our study intends to primarily evaluate the efficacy of cryoneurolysis as a preoperative pain management intervention. Establishing the use of cryoneurolysis for preoperative pain will provide a valuable resource for reducing the pain patients experience while awaiting surgery, leading to decreased opioid use and improved overall well-being. The investigators will be recruiting 30 participants total (15 having TKA and 15 having THA) that will be given cryoneurolysis while waiting for their surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoneurolysis | Experimental | Procedure: CryoneurolysisParticipants will receive a diagnostic nerve block with local anesthetic. This block will be performed on nerves that supply the hip joint or knee joint depending on location of osteoarthritis. If pain relief is greater than 50%, cryoneurolysis will be performed targeting nerves that supply the hip or knee joint with very low temperatures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Currently awaiting THA or TKA (have signed consent for surgery)
- Osteoarthritis as a primary diagnosis for THA or TKA
- Currently taking regular daily opioids for at least one month
- No allergies to local aesthetics
- Speaks and understands English
Key exclusion criteria (12 listed)
- If surgery is expected to be completed within 1 month of the intervention as this would limit our ability to evaluate the effectiveness of the cryoneurolysis procedure
- Allergies to local anesthetics
- Inability to communicate with investigators
- Opioid use disorder
- History of severe psychiatric or medical conditions which hinder effective communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoneurolysisTargeting of specific nerves related to surgical procedure using very low temperatures | Procedure or surgery | Cryoneurolysis |
Primary outcome
Oral Morphine Equivalent Consumption
Time frame: Pre-intervention, 2-weeks, 4-weeks, 8-weeks, 6 months, and 1-year post-intervention; 2-weeks, 6-weeks, 12-weeks postoperative
Daily Oral Morphine Equivalent Consumption
3 secondary outcomes
NRS Pain Score
Time frame: Pre-intervention, 2-weeks, 4-weeks, 8-weeks, 6 months, and 1-year post-intervention; 2-weeks, 6-weeks, 12-weeks postoperative
EQ-5D Score
Time frame: Pre-intervention, 2-weeks, 4-weeks, 8-weeks, 6 months, and 1-year post-intervention; 2-weeks, 6-weeks, 12-weeks postoperative
WOMAC Score
Time frame: Pre-intervention, 2-weeks, 4-weeks, 8-weeks, 6 months, and 1-year post-intervention; 2-weeks, 6-weeks, 12-weeks postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Endersby, MD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurolysis in people with Hip Arthropathy and Knee Arthropathy, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Endersby, MD (403-956-3827, ryan.endersby@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Morphine Equivalent Consumption (time frame: Pre-intervention, 2-weeks, 4-weeks, 8-weeks, 6 months, and 1-year post-intervention; 2-weeks, 6-weeks, 12-weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.