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
  Purpose

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 Intervention
Intervertebral Disk Degeneration
Other: Hyperlordotic Positioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Operative Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 52
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326091

Contacts
Contact: Jessica R Moreno, RN, BSN 919-668-6712 jessica.moreno@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jessica Moreno, RN, BSN    919-668-6712    jessica.moreno@duke.edu   
Principal Investigator: Oren N Gottfried, MD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Oren N Gottfried, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01326091     History of Changes
Other Study ID Numbers: Pro00028159
Study First Received: March 29, 2011
Last Updated: June 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Lumbar fusion surgery

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

ClinicalTrials.gov processed this record on October 19, 2014