ACL Repair
Conditions
Keywords
ACL Repair, Cryoneurolysis
Brief summary
The purpose of the research is to investigate the effect of preoperative Cryoneurolysis of the knee on postoperative pain management in patients undergoing autograft anterior cruciate ligament (ACL) reconstruction (a surgical procedure that makes a new ACL using the patient's own tendon). Cryoneurolysis is an approved process of applying extreme cold temperatures to targeted nerves in order to decrease or eliminate pain. . If you take part in the research, you will be randomly assigned (assigned by chance, like a flip of a coin) to Group A (standard care) or Group B (standard care plus Cryoneurolysis). Participants in both groups will undergo standard ACL reconstruction and receive standard preoperative and postoperative pain management. Participants in Group B only will also receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days before their scheduled surgery. Participants in both groups (A & B) will be asked to bring their remaining postoperative pain medication to their postoperative follow-up appointments for review by study personnel. Participants will also be asked to complete a survey about their knee activity, function and symptoms at these appointments. Your time in the study will last until the completion of the 12-week postoperative follow-up appointment.
Interventions
PROCEDURECryoneurolysis
Those randomized to the intervention group (Group B) will receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days of their scheduled surgery. Treatment nerves for the procedure will include the anterior femoral cutaneous nerve (AFCN), supra-patellar branch of the saphenous nerve (SPBSN) and infra-patellar branch of the saphenous nerve (IPBSN).
Sponsors
Virtua Health, Inc.
Pacira Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Patients aged 14 and over * Patients who are patients within the PI's practice * Patients who can speak and read English * Patients undergoing autograft ACL reconstruction. * Patients who are opioid naïve
Exclusion criteria
* \- Under the age of 14 * Non-English speaking/reading patients * Patients with Reynauds' syndrome * Patients with skin disorders or hypo-vascularity * Patients undergoing allograft ACL reconstruction. * Patients who consistently use opioids preoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative opioid consumption | Measured at 1-week, 6-weeks, 12-weeks | average daily morphine milliequivalents (MMEs) over the measured postoperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IKDC Subjective Knee Evaluation Form | 1-week, 6-week, 12-week postoperative period | 10-item self-rated scale measuring symptoms, athletic activity, and knee function. |
Countries
United States
Contacts
CONTACTSean Mc Millan, DO
Outcome results
None listed