Efficacy of Suction Enabled Retraction Device
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 22 - 99 |
| Updated: | 2/17/2019 |
| Start Date: | June 20, 2017 |
| End Date: | December 28, 2018 |
Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery
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.
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.
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.
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.
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
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