Clinical Trials Directory

Trials / Terminated

TerminatedNCT01326091

Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction

Operative Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This is a parallel, randomized controlled trial comparing two types of patient positioning and their effect on radiologic measures (pre-surgery visit, in the operating room prior to surgery, at the conclusion of surgery, and at 3 weeks after surgery at patients' postoperative visits) as well as surgeon satisfaction (prior to the end of the surgery) and patient outcomes using patient self reported scales (pre-surgery, post surgery at 3 weeks follow-up).

Detailed description

The investigators are evaluating how patient positioning affects radiologic metrics as well as surgeon satisfaction (surgeon being blinded to positioning). Patients will be allocated to either a hyperlordotic or a standard positioning group by computer generated randomization. Surgeons will perform all of their standard techniques to promote lordosis with instrumentation. Adult patients, ages 18-65, undergoing lumbar surgical fusion will be asked to participate.

Conditions

Interventions

TypeNameDescription
OTHERHyperlordotic PositioningHyperlordotic positioning will be achieved through pelvic pads positioned low on iliac crest to maximize lumbar hyperlordosis and increased hip flexion with as many pillows as tolerated at thighs and knees to allow for increased sacral slope. Regular position will involve the pelvic pads at above or iliac crest and without extra pillows at thighs and legs.

Timeline

Start date
2011-03-01
Primary completion
2015-02-01
Completion
2015-02-01
First posted
2011-03-30
Last updated
2015-06-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01326091. Inclusion in this directory is not an endorsement.