Back to resultsPatient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction
Primary Purpose
Intervertebral Disk Degeneration
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperlordotic Positioning
Sponsored by
About this trial
This is an interventional treatment trial for Intervertebral Disk Degeneration focused on measuring Lumbar fusion surgery
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard Positioning
Hyperlordotic Positioning
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01326091
Brief Title
Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction
Official Title
Operative Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient study support
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disk Degeneration
Keywords
Lumbar fusion surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Positioning
Arm Type
No Intervention
Arm Title
Hyperlordotic Positioning
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hyperlordotic Positioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess if the specific intra-operative positioning affects post-operative sagittal alignment
Description
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
Time Frame
Will be assessed during immediate post-operative period (day 1) as well as 3 weeks post-operatively
Secondary Outcome Measure Information:
Title
Surgeon satisfaction with operative patient positioning
Description
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.
Time Frame
During surgery (day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oren N Gottfried, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction
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