In-person Randomized Control Trial of the Incidence of Postoperative Hypoesthesia Among Bilateral Sagittal Split Osteotomy Patients Treated With Ultrasonic vs. Reciprocating Saw Instrumentation

Status: Enrolling by invitation
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw. Patients included in the study are ages 15-45 scheduled to undergo BSSO surgery at the University of California, San Francisco. One side of the patient's mandible will be instrumented with either the Stryker Sonopet ultrasonic saw or traditional reciprocating saw, while the other side will receive the remaining intervention (determined via randomization on the day of surgery). Patient paresthesias will then be analyzed on each side for 3 months postoperatively (at postoperative days: 1, 7, 14, 28, and 84). Sensory examinations will be carried out by blinded examiners using von Frey hairs and two point discrimination testing. Patients will also subjectively rate their sensation on each side. The results will then be analyzed to determine if patient paresthesias, including the severity and duration, differed depending on which instrument was used, the ultrasonic or reciprocating saw.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 45
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Must be undergoing bilateral sagittal split osteotomy surgery with Dr. Saghezchi at UCSF

• Must agree to return for all follow up visits.

• Must not have any preexisting V3 nerve paresthesia

• Must be below the age of 45.

Locations
United States
California
UCSF Benioff Children's Hospital
San Francisco
University of California, San Francisco Medical Center
San Francisco
Time Frame
Start Date: July 20, 2021
Estimated Completion Date: July 2023
Participants
Target number of participants: 50
Treatments
Placebo Comparator: Reciprocating saw
The traditional surgical instrument used for cutting bilateral sagittal split osteotomies
Active Comparator: Sonopet ultrasonic saw
This instrument is being compared to the reciprocating saw
Authors
Sohail Saghezchi
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov