Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-45 years
Scheduled for primary ACLR with BPTB autograft
Willingness and ability to participate in Iovera
No chronic opioid use preoperatively
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pacira Iovera Cryoneurolysis device
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.
Placebo/Sham device
DeviceThe placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Ioveraº cryoneurolysis study groupExperimental treatment 1 intervention
Group B: Placebo study groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 1 Month2
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.
Time frame
Baseline, 1 MonthSecondary outcomes
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.
Time frame
Baseline, Post-operative Day 12
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.
Time frame
Baseline, Week 33
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.
Time frame
Baseline, Month 64
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"
Time frame
Baseline, Post-operative Day 1Sponsors and contacts
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Source ClinicalTrials.gov
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