Freezing nerves before knee surgery may slash painkiller needs
NCT ID NCT07731178
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial tests whether freezing specific nerves before ACL reconstruction can reduce post-surgery pain and the need for opioid medications. About 150 people aged 18 to 45 scheduled for ACL surgery with a bone-patellar tendon-bone graft will receive either the nerve-freezing treatment or a sham procedure. The study measures pain, knee function, and recovery one month after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a device that freezes nerves to block pain signals before surgery
- What this could lead to
- If it works, this could offer a non-drug way to manage post-surgery pain and reduce reliance on opioids.
- What could go wrong
- This is an early-stage trial with a sham comparison, so the real benefit over placebo is uncertain. Nerve freezing may cause temporary numbness or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-45 years 2. Scheduled for primary ACLR with BPTB autograft 3. Willingness and ability to participate in Iovera 4. No chronic opioid use preoperatively 5. No known neurologic disorders affecting the lower extremity 6. Capacity and willingness to provide informed consent and comply with follow-up schedules Exclusion Criteria: 1. Prior surgery on the affected knee. 2. Non-English speaking if validated PRO instruments at the site are only available in English; include validated translations if available and approved. 3. Contraindications to cryoneurolysis (e.g., cryoglobulinemia, cold urticaria, Raynaud's phenomenon, paroxysmal cold hemoglobinuria) or to local anesthetics. 4. Active skin infection, dermatitis, or compromised skin integrity at or near treatment sites. 5. Bleeding diathesis or anticoagulant therapy not compatible with minor percutaneous procedures per institutional policy. 6. Pregnancy or breastfeeding. 7. Known peripheral neuropathy or significant sensory deficit of the target region. 8. Any condition that, in the investigator's judgment, increases risk or interferes with participation 9. Concomitant use of other opioid drugs or prior chronic use.
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Get notified about this study
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
New York, New York, 10016, United States
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