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

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ClinicalTrials.gov Identifier: NCT01326091
Recruitment Status : Terminated (Insufficient study support)
First Posted : March 30, 2011
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Duke University

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).

Condition or disease Intervention/treatment Phase
Intervertebral Disk Degeneration Other: Hyperlordotic Positioning Not Applicable

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Operative Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction
Study Start Date : March 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Surgeon satisfaction with operative patient positioning [ Time Frame: During surgery (day 1) ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326091


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Oren N Gottfried, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01326091     History of Changes
Other Study ID Numbers: Pro00028159
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: May 2015

Keywords provided by Duke University:
Lumbar fusion surgery

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases