Trial Outcomes & Findings for Posterior Spinal Fusion With Two Energy Dissection Techniques (NCT NCT02465099)

NCT ID: NCT02465099

Last Updated: 2018-02-19

Results Overview

Estimated blood loss during intraoperative Stage 1, defined as the period from first incision to the first bone violation/cut (e.g., first pedicle screw drill); and intraoperative Stage 2, defined as the period from first bone violation/cut to last suture.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 64 participants
• Primary outcome timeframe: Intraoperative
• Results posted on: 2018-02-19

Participant Flow

Participant milestones

Measure	Phase 1 Monopolar Electrocautery Dissection Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.	Phase II OSTEOVUE Ultrasonic Dissection Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
Overall Study STARTED	45	19
Overall Study COMPLETED	45	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Posterior Spinal Fusion With Two Energy Dissection Techniques

Baseline characteristics by cohort

Measure	Phase 1 Monopolar Electrocautery Dissection n=45 Participants Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.	Phase II OSTEOVUE Ultrasonic Dissection n=19 Participants Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.	Total n=64 Participants Total of all reporting groups
Age, Continuous	15.1 years STANDARD_DEVIATION 2.64 • n=5 Participants	14.5 years STANDARD_DEVIATION 1.84 • n=7 Participants	14.9 years STANDARD_DEVIATION 2.43 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	14 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	16 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	19 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative

Population: All subjects in which the procedure was started. There was one subject that was enrolled who was to receive treatment with ultrasonic dissection, but the procedure was not performed due to study closure. Therefore, N=19 subjects enrolled for the ultrasonic dissection group, but only 18 subjects received treatment.

Estimated blood loss during intraoperative Stage 1, defined as the period from first incision to the first bone violation/cut (e.g., first pedicle screw drill); and intraoperative Stage 2, defined as the period from first bone violation/cut to last suture.

Outcome measures

Measure	Phase 1 Monopolar Electrocautery Dissection n=45 Participants Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.	Phase II OSTEOVUE Ultrasonic Dissection n=18 Participants Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
Estimated Intraoperative Blood Loss	134 milliliters Standard Deviation 124	163 milliliters Standard Deviation 146

Adverse Events

Phase 1 Monopolar Electrocautery Dissection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase II OSTEOVUE Ultrasonic Dissection

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

Jason Waggoner

Ethicon Inc

Phone: (513) 337-8130

Email: jwaggon1@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PIs agreed that the first publication of results should be made in conjunction with the presentation of a joint, multicenter publication of the results with all sites contributing data, analyses, and comments. If this publication was not submitted within 12 months after conclusion of the Study at all sites, or after Sponsor confirmed there would be no multicenter Study publication, whichever is first, the PIs could have published the results from their individual sites.
• Publication restrictions are in place

Restriction type: OTHER