Spinal Surgery, Surgical Blood Loss
Conditions
Keywords
open lumbar spine surgery, operative time and efficiency, Suction-Integrated Surgical Tissue Elevator and Retractor
Brief summary
This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue Elevator & Retractor \[SISTER\] device to assess: * Effects on operative time and efficiency of exposure in open lumbar spine cases. * Effect on total blood loss during the exposure part of the operation. * Rate of clogging of suction device.
Detailed description
The device, Suction-Integrated Surgical Tissue Elevator & Retractor \[SISTER\], is shaped like a Cobb elevator but also has a hollow core allowing suction tubing to be connected. Thus, a single hand can be used to retract and suction at the same time while the other hand separates soft tissue from the bones with electrocautery. This set up which is proposed to be more efficient will be evaluated in this study.
Interventions
DEVICESISTER device
Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery
Sponsors
Ludwig Medical Corporation
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking * Patients undergoing lumbar one to sacral one open instrumentation * Surgery performed by the Departments of Neurological Surgery and Orthopedics at the University of MIami Miller School of Medicine
Exclusion criteria
* Less than 22 years old * Procedure does not involve instrumentation * Prior lumbar spine surgery involving more than one level * BMI less than 20 or greater than 35 * Known bleeding conditions ( ex. Factor V Leiden, Von Willebrand) * Routinely taking anticoagulation medicine (ex. aspirin 325 mg/day, Plavix) * Operative cases where a single surgeon performs both sides of exposure * Pregnant women * Prisoners * Adults unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | 1.5 hours | Amount of blood loss from incision time to screw placement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Exposure | 1.5 hours | Length of operation in minutes |
| Rate of Clogging | 1.5 hours | Average number of times the suction tip of the device had to be unclogged |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Use of Cobb Device Use of SISTER device during surgery
SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery | 10 |
| Control Standard exposure technique and instruments will be used during surgery | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Use of Cobb Device | Control | Total |
|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 11.8 | 71.1 years STANDARD_DEVIATION 7.4 | 68.2 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Estimated Blood Loss
Amount of blood loss from incision time to screw placement
Time frame: 1.5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Use of Cobb Device | Estimated Blood Loss | 364.0 ml | Standard Deviation 363.1 |
| Control | Estimated Blood Loss | 356.0 ml | Standard Deviation 256.5 |
p-value: 0.96t-test, 2 sided
Secondary
Rate of Clogging
Average number of times the suction tip of the device had to be unclogged
Time frame: 1.5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Use of Cobb Device | Rate of Clogging | 10.1 tip clogs | Standard Deviation 4.9 |
| Control | Rate of Clogging | 4.9 tip clogs | Standard Deviation 6 |
p-value: 0.05t-test, 2 sided
Secondary
Time of Exposure
Length of operation in minutes
Time frame: 1.5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Use of Cobb Device | Time of Exposure | 38.2 minutes | Standard Deviation 9 |
| Control | Time of Exposure | 69.7 minutes | Standard Deviation 56.1 |
p-value: 0.11t-test, 2 sided