Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Miami
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Estimated Blood Loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 22 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Use of Cobb device
Use of SISTER device during surgery
Intervention: SISTER device (Device)
Control
Standard exposure technique and instruments will be used during surgery
Outcomes
Primary Outcomes
Estimated Blood Loss
Time Frame: 1.5 hours
Amount of blood loss from incision time to screw placement
Secondary Outcomes
- Time of Exposure(1.5 hours)
- Rate of Clogging(1.5 hours)
Investigators
Ian Cote
Assistant Professor
University of Miami