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Clinical Trials/NCT06603051
NCT06603051
Recruiting
Not Applicable

The Effect of Pre-Operative Cryoneurolysis on Post-Operative Narcotic Consumption in Patients Undergoing Autograft ACL Reconstruction

Virtua Health, Inc.2 sites in 1 country20 target enrollmentAugust 28, 2024
ConditionsACL Repair

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ACL Repair
Sponsor
Virtua Health, Inc.
Enrollment
20
Locations
2
Primary Endpoint
Post-operative opioid consumption
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 28, 2024
End Date
February 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Post-operative opioid consumption

Time Frame: Measured at 1-week, 6-weeks, 12-weeks

average daily morphine milliequivalents (MMEs) over the measured postoperative period

Secondary Outcomes

  • IKDC Subjective Knee Evaluation Form(1-week, 6-week, 12-week postoperative period)

Study Sites (2)

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