ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) AutograftNCT07731178
Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)
A study testing Pacira Iovera Cryoneurolysis device in people with ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this research study is to assess whether cryoneurolysis will help control pain after ACLR surgery and decrease the need of opioid medications. The primary objective is to compare postoperative functional recovery between Iovera and sham arms at 1 month after ACLR. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft
- What is being tested?
- Pacira Iovera Cryoneurolysis device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years
- Scheduled for primary ACLR with BPTB autograft
- Willingness and ability to participate in Iovera
- No chronic opioid use preoperatively
- No known neurologic disorders affecting the lower extremity
- Capacity and willingness to provide informed consent and comply with follow-up schedules
Who cannot join
- Prior surgery on the affected knee.
- Non-English speaking if validated PRO instruments at the site are only available in English; include validated translations if available and approved.
- Contraindications to cryoneurolysis (e.g., cryoglobulinemia, cold urticaria, Raynaud's phenomenon, paroxysmal cold hemoglobinuria) or to local anesthetics.
- Active skin infection, dermatitis, or compromised skin integrity at or near treatment sites.
- Bleeding diathesis or anticoagulant therapy not compatible with minor percutaneous procedures per institutional policy.
- Pregnancy or breastfeeding.
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- Known peripheral neuropathy or significant sensory deficit of the target region.
- Any condition that, in the investigator's judgment, increases risk or interferes with participation
- Concomitant use of other opioid drugs or prior chronic use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Efficacy of Preoperative Cryoneurolysis With Iovera on Postoperative Pain, Function, and Opioid Use Following ACL Reconstruction With Bone-Patellar Tendon-Bone Autograft
The purpose of this research study is to assess whether cryoneurolysis will help control pain after ACLR surgery and decrease the need of opioid medications. The primary objective is to compare postoperative functional recovery between Iovera and sham arms at 1 month after ACLR.
- Being tested
- Pacira Iovera Cryoneurolysis device, Placebo/Sham device
- Keywords
- ACLR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacira Iovera Cryoneurolysis deviceDevice
The device includes a hand-held piece, charging port with cord, and disposable components: the nitrous oxide capsule and a small probe called the Smart Tip, which has needles that administer the cold to the nerve. It works immediately by freezing nerves that transmit pain signals to reduce pain transmission after surgery.
Placebo/Sham deviceDevice
The placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ioveraº cryoneurolysis study group | Experimental | Participants will receive the ioveraº cryoneurolysis intervention before surgery. Receives: Device: Pacira Iovera Cryoneurolysis device |
| Placebo study group | Sham comparator | Participants will have a sham intervention that does not have cryoneurolysis before surgery. Receives: Device: Placebo/Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Measured: Baseline, 1 Month
Difference in Lysholm knee scoring scale (LKSS)
The Lysholm knee scoring scale is a 100-point patient-reported questionnaire designed to assess functional knee ligament injuries. It evaluates eight areas - limp, support, locking, instability, pain, swelling, stair climbing, and squatting - with higher scores (up to 100) indicating better function.
Measured: Baseline, 1 Month
Secondary outcomes (7)
Change in Visual Analogue Scale (VAS) for Pain score
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Baseline, Post-operative Day 1
Change in Visual Analogue Scale (VAS) for Pain score
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Baseline, Week 3
Change in Visual Analogue Scale (VAS) for Pain score
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Baseline, Month 6
Change in Numeric Rating Scale (NRS)
A segmented, numbered version of the VAS. Patients select a whole number from 0 to 10 where 0 is "no pain" and 10 is the "worst pain imaginable"
Measured: Baseline, Post-operative Day 1
Change in Numeric Rating Scale (NRS)
A segmented, numbered version of the VAS. Patients select a whole number from 0 to 10 where 0 is "no pain" and 10 is the "worst pain imaginable"
Measured: Baseline, Week 3
Change in Numeric Rating Scale (NRS)
A segmented, numbered version of the VAS. Patients select a whole number from 0 to 10 where 0 is "no pain" and 10 is the "worst pain imaginable"
Measured: Baseline, Month 6
Cumulative opioid consumption as measured by morphine milligram equivalents (MME)
Measured: Up to 21 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) AutograftStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric J. Strauss, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731178
- Sponsor's protocol ID
- 25-00771
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a single-site device study. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to layne.estes@nyulangone.org.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Preoperative Cryoneurolysis With Iovera on Postoperative Pain, Function, and Opioid Use Following ACL Reconstruction With Bone-Patellar Tendon-Bone Autograft
- ClinicalTrials.gov ID
- NCT07731178
- Acronym / sponsor ID
- 25-00771
- Keywords
- ACLR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Jul 2026 (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.
The purpose of this research study is to assess whether cryoneurolysis will help control pain after ACLR surgery and decrease the need of opioid medications. The primary objective is to compare postoperative functional recovery between Iovera and sham arms at 1 month after ACLR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ioveraº cryoneurolysis study group | Experimental | Device: Pacira Iovera Cryoneurolysis deviceParticipants will receive the ioveraº cryoneurolysis intervention before surgery. |
| Placebo study group | Sham comparator | Device: Placebo/Sham deviceParticipants will have a sham intervention that does not have cryoneurolysis before surgery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45 years
- Scheduled for primary ACLR with BPTB autograft
- Willingness and ability to participate in Iovera
- No chronic opioid use preoperatively
- No known neurologic disorders affecting the lower extremity
Key exclusion criteria (9 listed)
- Prior surgery on the affected knee.
- Non-English speaking if validated PRO instruments at the site are only available in English; include validated translations if available and approved.
- Contraindications to cryoneurolysis (e.g., cryoglobulinemia, cold urticaria, Raynaud's phenomenon, paroxysmal cold hemoglobinuria) or to local anesthetics.
- Active skin infection, dermatitis, or compromised skin integrity at or near treatment sites.
- Bleeding diathesis or anticoagulant therapy not compatible with minor percutaneous procedures per institutional policy.
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 |
|---|---|---|
| Pacira Iovera Cryoneurolysis deviceThe device includes a hand-held piece, charging port with cord, and disposable components: the nitrous oxide capsule and a small probe called the Smart Tip, which has needles that administer the cold to the nerve. It works immediately by freezing nerves that transmit pain signals to reduce pain transmission after surgery. | Device | Ioveraº cryoneurolysis study group |
| Placebo/Sham deviceThe placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment. | Device | Placebo study group |
Primary outcome
Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 1 Month
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Difference in Lysholm knee scoring scale (LKSS)
Time frame: Baseline, 1 Month
The Lysholm knee scoring scale is a 100-point patient-reported questionnaire designed to assess functional knee ligament injuries. It evaluates eight areas - limp, support, locking, instability, pain, swelling, stair climbing, and squatting - with higher scores (up to 100) indicating better function.
7 secondary outcomes
Change in Visual Analogue Scale (VAS) for Pain score
Time frame: Baseline, Post-operative Day 1
Change in Visual Analogue Scale (VAS) for Pain score
Time frame: Baseline, Week 3
Change in Visual Analogue Scale (VAS) for Pain score
Time frame: Baseline, Month 6
Change in Numeric Rating Scale (NRS)
Time frame: Baseline, Post-operative Day 1
Change in Numeric Rating Scale (NRS)
Time frame: Baseline, Week 3
Change in Numeric Rating Scale (NRS)
Time frame: Baseline, Month 6
Cumulative opioid consumption as measured by morphine milligram equivalents (MME)
Time frame: Up to 21 days post-operative
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 28 Jul 2026.
- Individual participant dataSharing planned: No. This is a single-site device study. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to layne.estes@nyulangone.org.
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.
Eric J. Strauss, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacira Iovera Cryoneurolysis device in people with ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft, run by NYU Langone Health at 1 site in United States.
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 6 inclusion and 9 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Layne Estes (646-501-7208, Layne.estes@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline, 1 Month). The study lists 2 primary outcomes in all. 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 28 Jul 2026.