Trial Outcomes & Findings for Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis (NCT NCT02781324)

NCT ID: NCT02781324

Last Updated: 2021-01-13

Results Overview

Estimated blood loss is being obtained from the report generated by the cell saver.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: Intraoperative
• Results posted on: 2021-01-13

Participant Flow

Participant milestones

Measure	Ultrasonic Bone Scalpel Group Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Overall Study STARTED	33	33
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Ultrasonic Bone Scalpel Group Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	2

Baseline Characteristics

Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

Baseline characteristics by cohort

Measure	Ultrasonic Bone Scalpel Group n=31 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=31 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	30 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	31 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative

Population: The above 65 patients were analyzed as part of a treated cohort and an intention-to-treat cohort. The discrepancy between the 65 patients with data evaluated and the 66 patients initially consented is explained by 1 patient who withdrew consent from the study. The study team therefore did not feel it was ethical to collect this patient's data.

Estimated blood loss is being obtained from the report generated by the cell saver.

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=33 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Estimated Blood Loss/Level	35.21 mL Standard Deviation 18.09	38.68 mL Standard Deviation 15.34

SECONDARY outcome

Timeframe: Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery)

This outcome measure measures the number of patients with intraoperative and postoperative blood transfusions placed in the Ultrasonic Bone Scalpel Group and the Standard of Care Group.

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=33 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group	32 Participants	33 Participants

SECONDARY outcome

Timeframe: Intraoperative (for duration of the procedure)

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=33 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Procedure Time (Minutes)	157.5 minutes Standard Deviation 39.46	159.7 minutes Standard Deviation 36.25

OTHER_PRE_SPECIFIED outcome

Timeframe: Preoperative (up to 1 month before scheduled date of surgery)

measured from preoperative radiographs

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=33 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Preoperative Major Cobb Angle (Degrees)	49.78 degrees Standard Deviation 8.37	51.15 degrees Standard Deviation 7.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Short Term Postoperative (3 month), Long Term Postoperative (1 year)

Cobb angle is a measurement of the degree of side-to-side spinal curvature used to define Scoliosis. A Cobb angle of 10 degrees is the minimum angle to define scoliosis. Angles of 40-50 degrees or more may require corrective surgery. Cobb angle will be measured from postoperative radiographs

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Intraoperative

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=33 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Number of Vertebral Levels Fused	10.53 vertebral levels Standard Deviation 2.74	10.55 vertebral levels Standard Deviation 1.82

OTHER_PRE_SPECIFIED outcome

Timeframe: Preoperative (on day of surgery)

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=33 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
BMI Percentile at Surgery	53.92 percentile Standard Deviation 28.42	55.7 percentile Standard Deviation 25.63

OTHER_PRE_SPECIFIED outcome

Timeframe: Preoperative (on day of surgery)

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=33 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Weight (kg) at Surgery	52.45 kilograms Standard Deviation 10.37	54.14 kilograms Standard Deviation 8.96

OTHER_PRE_SPECIFIED outcome

Timeframe: Preoperative (up to 1 month before scheduled date of surgery)

Lenke Type 1 is a main thoracic curve pattern, and is the most common pattern observed in cases of adolescent idiopathic scoliosis (AIS). The Lenke Classification System provides surgeons with a simple, accurate, and reproducible way to communicate about scoliosis. It relies on measurements taken from standard x-rays. The surgeon evaluates the x-ray from the front, side, and in bending positions. Each scoliosis curve is then classified in three ways: by the curve type based on the three regions of the spine, a lumbar spine modifier, and a sagittal thoracic modifier. The classification system combines the curve type (1-6) with the lumbar modifier (A, B, C) and the sagittal thoracic modifier (-. N, +) to form the complete classification.

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=33 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Percent of Participants With Lenke 1 Curve Pattern	53 percentage of participants	64 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Preoperative (prior to first incision)

Population: one less standard of care participant analyzed because labs were not drawn in designated window.

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=32 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Preoperative Hematocrit	38.24 grams/deciliter Standard Deviation 5.77	36.5 grams/deciliter Standard Deviation 12.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Short Term Postoperative (12-18 hours after procedure)

Population: deviation in numbers due to some postop labs not being drawn and therefore no postop hematocrit values were collected

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=30 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=30 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Postoperative Hematocrit	30.39 grams/deciliter Standard Deviation 10.7	30.45 grams/deciliter Standard Deviation 9.51

OTHER_PRE_SPECIFIED outcome

Timeframe: Intraoperative

Outcome measures

Measure	Ultrasonic Bone Scalpel Group n=32 Participants Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel	Standard of Care Group n=33 Participants Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion
Intraoperative Use of Antifibrinolytic	32 Participants	33 Participants

Adverse Events

Ultrasonic Bone Scalpel Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eun Kim, Spine Research Assistant

Children's Hospital Colorado

Phone: 720-777-8026

Email: eun.kim@childrenscolorado.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place