Cryoneurolysis for ACL Reconstruction
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should be opioid naïve, meaning they should not be regularly using opioids before the surgery.
What data supports the effectiveness of the treatment Cryoneurolysis for ACL Reconstruction?
Research shows that ultrasound-guided cryoneurolysis, a technique using cold temperatures to target nerves, has been effective in providing pain relief after surgeries like mastectomy and thoracic surgery. Patients have reported long-term pain relief and improved function, suggesting it could be a useful option for managing pain after ACL reconstruction.12345
Is cryoneurolysis generally safe for humans?
Cryoneurolysis, which uses extreme cold to treat nerve pain, is considered a safe procedure with minimal risk of complications when done with imaging guidance. Studies have shown it provides pain relief without causing permanent nerve damage, and no serious complications have been identified in patients.12367
How does cryoneurolysis differ from other treatments for ACL reconstruction?
Cryoneurolysis is unique because it uses extremely cold temperatures to temporarily block pain signals by freezing the nerves, unlike other treatments that may rely on medications or physical therapy. This method is guided by ultrasound to ensure precise targeting of the nerves, potentially offering long-term pain relief without the need for drugs.12345
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for patients scheduled for ACL reconstruction using their own tendon. They must be able to undergo standard care and willing to potentially receive Cryoneurolysis before surgery. Specific eligibility criteria are not provided, but typically include being in good health with no conditions that would interfere with the study or recovery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Participants in Group B receive Cryoneurolysis treatment 7-10 days before surgery
Surgery and Immediate Post-operative Care
Participants undergo ACL reconstruction and receive standard preoperative and postoperative pain management
Follow-up
Participants are monitored for safety and effectiveness, with assessments at 1-week, 6-weeks, and 12-weeks post-surgery
Treatment Details
Interventions
- Cryoneurolysis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virtua Health, Inc.
Lead Sponsor
Pacira Pharmaceuticals, Inc
Industry Sponsor
Dr. Jonathan Slonin
Pacira Pharmaceuticals, Inc
Chief Medical Officer since 2020
BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University
Frank D. Lee
Pacira Pharmaceuticals, Inc
Chief Executive Officer since 2024
BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business