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

Duke University

Status: Terminated

Conditions: Intervertebral Disk Degeneration

Treatments: Other: Hyperlordotic Positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01326091

Pro00028159

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups

Standard Positioning

No Intervention group

Hyperlordotic Positioning

Active Comparator group

Description:

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.

Treatment:

Other: Hyperlordotic Positioning