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

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).

Study Overview

• Status: Terminated
• Conditions: Intervertebral Disk Degeneration
• Intervention / Treatment: Other: Hyperlordotic Positioning

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults patients, aged between 18 and 65 years of age
• Patients undergoing lumbar fusion for degenerative conditions

Exclusion Criteria:

• Patients < 18 years of age or > 65 years of age
• Patients who have a history of metastatic disease
• Patients who currently have a pending workman's compensation claim
• Patients who have had a previous spinal surgery
• Patients who have or have had a spinal infection
• Patients who have a spinal deformity, such as scoliosis
• Women who are pregnant
• Inpatients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Positioning
Active Comparator: Hyperlordotic Positioning; Hyperlordotic 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.	Other: Hyperlordotic Positioning; Hyperlordotic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess if the specific intra-operative positioning affects post-operative sagittal alignment	X-rays will be performed at patients' pre-surgery visit, in the operating room prior to surgery and at the conclusion of surgery, and at 3 weeks after surgery at patients' postoperative visit. The specifics of the pelvic parameters will be measured at these visits. Also, the patient will complete VAS, ODI (Davidson, 2002; Fairbank, 2000 ), and WHOQOL-BREF prior to surgery and at 3 weeks follow-up. We will collect data on any complications occurring in the perioperative period till 3 weeks after surgery	Will be assessed during immediate post-operative period (day 1) as well as 3 weeks post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon satisfaction with operative patient positioning	Satisfaction ratings with regard to comfort in performing decompression and fusion will be collected by the coordinator prior to the end of the surgery to ensure that the surgeon remains blinded to allocation. It will be measured through a questionnaire using a series of verbal analog scales where 0 is completely unsatisfied and 10 is completely satisfied, the surgeon's degree of satisfaction with patient positioning and ease or difficulty in performing the surgery.	During surgery (day 1)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Oren N Gottfried, MD, Duke University

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Lumbar fusion surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: Pro00028159

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No