Trial Outcomes & Findings for TissueLink Study During Multi-Level Spine Surgery (NCT NCT01300559)

Last Updated: 2013-02-07

Results Overview

The primary hypothesis was that use of the Aquamantys coagulation system in addition to unipolar cautery results in less intraoperative Hb loss compared with unipolar cautery alone during multilevel spinal decompression and fusion surgery.Intraoperatively, shed blood will be collected into a Cell-saver device. Surgical sponges will be recovered in a container of citrated normal saline. Prior to processing the salvaged blood from the cell-saver device, hemoglobin concentration (g/dL) and volume (dL) of the salvaged blood will be measured, allowing calculation of hemoglobin loss in grams.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

At the end of surgery

Results posted on

2013-02-07

Participant Flow

60 adult patients (age ≥ 18 years) undergoing elective, multilevel, posterior lumbar decompression and fusion with Dr William Richardson were randomly assigned into two groups.

Enrollment started 10/09/2006 and enrollment completed 09/13/2010 with a total of 60 eligible subjects.

Participant milestones

Participant milestones
Measure	Treatment Group Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.	No Treatment Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TissueLink Study During Multi-Level Spine Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=30 Participants Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.	No Treatment n=30 Participants Unipolar electrocautery without Tissuelink device will be used in this arm of the study.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=99 Participants	18 Participants n=107 Participants	35 Participants n=206 Participants
Age, Categorical >=65 years	13 Participants n=99 Participants	12 Participants n=107 Participants	25 Participants n=206 Participants
Age Continuous	62.6 years STANDARD_DEVIATION 11.3 • n=99 Participants	61.8 years STANDARD_DEVIATION 10 • n=107 Participants	62.2 years STANDARD_DEVIATION 10.7 • n=206 Participants
Sex: Female, Male Female	22 Participants n=99 Participants	19 Participants n=107 Participants	41 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	11 Participants n=107 Participants	19 Participants n=206 Participants
Region of Enrollment United States	30 participants n=99 Participants	30 participants n=107 Participants	60 participants n=206 Participants

PRIMARY outcome

Timeframe: At the end of surgery

Population: Based on pilot data, it was estimated that 29 patients per group would provide 90% power with = 0.01 to distinguish such a difference between groups. Therefore, the randomized study was planned for 60 patients.

Outcome measures

Outcome measures
Measure	Treatment Group n=30 Participants Tissuelink device plus Unipolar electrocautery will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.	No Treatment Group n=30 Participants Unipolar electrocautery without Tissuelink device will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
Hemoglobin Measurement g/dl	66.2 hemoglobin g/dl Interval 14.4 to 174.1	102.4 hemoglobin g/dl Interval 55.5 to 197.3

Adverse Events

Treatment Group

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=30 participants at risk Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.	No Treatment n=30 participants at risk Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
Vascular disorders Serous wound drainage without evidence of infection.	3.3% 1/30 • Number of events 1 • 30 days Clinical assessment of subjects	0.00% 0/30 • 30 days Clinical assessment of subjects
Skin and subcutaneous tissue disorders Dural tear. (Spinal tissue tear)	3.3% 1/30 • Number of events 1 • 30 days Clinical assessment of subjects	0.00% 0/30 • 30 days Clinical assessment of subjects
Vascular disorders Wound hematoma. (bruise)	3.3% 1/30 • Number of events 1 • 30 days Clinical assessment of subjects	0.00% 0/30 • 30 days Clinical assessment of subjects
Infections and infestations Urinary tract infection.	0.00% 0/30 • 30 days Clinical assessment of subjects	3.3% 1/30 • Number of events 1 • 30 days Clinical assessment of subjects
Cardiac disorders Atrial fibrillation. (Irregular heart beat)	0.00% 0/30 • 30 days Clinical assessment of subjects	3.3% 1/30 • Number of events 1 • 30 days Clinical assessment of subjects
Infections and infestations Fever with a gout flare.	0.00% 0/30 • 30 days Clinical assessment of subjects	3.3% 1/30 • Number of events 1 • 30 days Clinical assessment of subjects

Other adverse events

Adverse event data not reported

Additional Information

Steven E. Hill, M.D.

Duke University Medical Center

Phone: 681-6614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60