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

Intervertebral Disk Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01326091
• Other study ID #: Pro00028159
• Status: Terminated
• Phase: N/A
• First received: March 29, 2011
• Last updated: June 22, 2015
• Start date: March 2011
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disk Degeneration

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No