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

NCT01326091 | Terminated DMC

• 1 other identifier: Pro00028159
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Intervertebral Disk Degeneration

Keywords

Lumbar fusion surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Surgeon satisfaction with operative patient positioning

  During surgery (day 1)

Study Arms (2)

Standard Positioning

NO INTERVENTION

Hyperlordotic Positioning

ACTIVE COMPARATOR

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

Interventions

Hyperlordotic Positioning OTHER

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.

Hyperlordotic Positioning

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults patients, aged between 18 and 65 years of age
• Patients undergoing lumbar fusion for degenerative conditions

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Oren N Gottfried, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 30, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-05

Locations

US (1)