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

Intervertebral Disk Degeneration Clinical Trial

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

Status Terminated

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disk Degeneration

• NCT number: NCT01326091
• Study type: Interventional
• Source: Duke University
• Status: Terminated
• Phase: N/A
• Start date: March 2011
• Completion date: February 2015