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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01326091
First received: March 29, 2011
Last updated: June 17, 2014
Last verified: June 2014

March 29, 2011
June 17, 2014
March 2011
March 2015   (final data collection date for primary outcome measure)
To assess if the specific intra-operative positioning affects post-operative sagittal alignment [ Time Frame: Will be assessed during immediate post-operative period (day 1) as well as 3 weeks post-operatively ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01326091 on ClinicalTrials.gov Archive Site
Surgeon satisfaction with operative patient positioning [ Time Frame: During surgery (day 1) ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Intervertebral Disk Degeneration
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.
  • 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.
    Intervention: Other: Hyperlordotic Positioning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
March 2016
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Jessica R Moreno, RN, BSN 919-668-6712 jessica.moreno@duke.edu
United States
 
NCT01326091
Pro00028159
Yes
Duke University
Duke University
Not Provided
Principal Investigator: Oren N Gottfried, MD Duke University
Duke University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP