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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
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.
The placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.
NYU Langone Health
New York, New York, United States
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 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.
Time frame: Baseline, 1 Month
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 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, Week 3
Change in Visual Analogue Scale (VAS) for Pain score
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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 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"
Time frame: 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"
Time frame: 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"
Time frame: Baseline, Month 6
Cumulative opioid consumption as measured by morphine milligram equivalents (MME)
Time frame: Up to 21 days post-operative