ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft
Conditions
Keywords
ACLR
Brief 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.
Interventions
DEVICEPacira Iovera Cryoneurolysis device
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.
DEVICEPlacebo/Sham device
The placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (VAS) for Pain score | Baseline, Post-operative Day 1 | 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. |
| Change in Numeric Rating Scale (NRS) | Baseline, Post-operative Day 1 | 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" |
| Cumulative opioid consumption as measured by morphine milligram equivalents (MME) | Up to 21 days post-operative | — |
Countries
United States
Contacts
CONTACTLayne Estes
CONTACTEric J. Strauss, MD
PRINCIPAL_INVESTIGATOREric J. Strauss, MD
NYU Langone Health
Outcome results
None listed