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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intervertebral Disk Degeneration

Intervention / Treatment
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* Other: Hyperlordotic Positioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Positioning<br> | |
| Active Comparator: Hyperlordotic Positioning<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar fusion surgery