Clinical trial NCT01055574: Physical Capability Outcomes After Single-Level PD-L vs Single-Level ALIF: a Multi-Center Clinical Trial
Official title: Physical Capability Outcomes After Single-Level ProDisc-L Total Disc Replacement or Single-Level Anterior Lumbar Interbody Fusion: a Multi-Center Clinical Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Physical Capability Outcomes
Keywords: lumbar disc arthroplasty
total disc replacement
ProDisc L
anterior lumbar interbody fusion
lumbar spine surgery outcomes
Lead sponsor: Gundersen Lutheran Medical Foundation
Sponsor class: OTHER
Collaborators: name: Synthes USA HQ, Inc.
First posted: 2010-01-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target study population are those meeting all the FDA criteria for ProDisc-L. Patients with third-party coverage for ProDisc-L that received surgical implantation of this device will be in one group. Patients without third-party coverage for ProDisc-L that underwent stand-alone ALIF with a device that incorporates fixation of the superior vertebral body to the inferior vertebral body, and where an osteoinductive biologic agent is placed within the device will be in the other group.

Brief summary: The purpose of this study is to compare the physical capability outcomes of patients who undergo single-level ProDisc-L disc replacement with those of patients who undergo stand-alone, single-level anterior lumbar interbody fusion (ALIF). This study will be the first multi-center clinical study to use clearly measurable outcomes from physical tests to compare the results of lumbar disc arthroplasty with disc fusion.

Detailed description: Physical capability testing will be conducted once before surgery and at 6 months and 1 year after surgery. Physical capability testing assesses the ability to perform a number of common tasks: the distance a subject can walk comfortably in 6 minutes; the amount of weight a subject can lift, push, pull, and carry; and the ability to squat and work bending forward in the kneeling and standing positions. The results of this testing will be evaluated to determine whether the subject's physical capability meets the physical requirements of their job, based on their responses to a pre-study questionnaire. Each physical capability testing session will require from 1 to 1 ½ hours of the subject's time. Physical capability testing will be provided without charge.

Eligibility criteria: Inclusion Criteria:

Eligible patients will meet the following criteria based on clinically appropriate criteria per standard of care at individual institutions which may include but are not limited to

* skeletally mature; BMI \< 40
* suffered from low-back pain with or without leg pain for 6 months or longer
* no evidence of spinal deformity on plain radiograph
* no evidence of angular instability on flexion extension radiographs
* severe and incapacitating low-back pain, defined as a score of 40% or greater on the Oswestry Disability Questionnaire
* a single level of degenerative disc disease at L34, L45, or L5-S1 on magnetic resonance imaging (MRI) scan
* discography, if indicated, reproduces pain at the level of degeneration noted on the MRI scan and is negative for pain reproduction at adjacent levels
* bone mineral density T-Score by DEXA Scan \>-1.0 for any skeletal region
* computed tomographic (CT) scan demonstrates the absence of pars defect at the index level
* CT scan demonstrates the absence of significant facet arthropathy at the index level
* considered reasonable candidates for surgery in regard to psychological factors as determined according to the standard of care at each participating center

Exclusion Criteria:

* active systemic infection
* evidence of alcoholism
* spondylolisthesis of greater than grade 1
* clinically significant lumbar spinal stenosis
* allergy to implant materials
* isolated radicular syndrome
* vertebral body compromised by trauma at the index level.

Primary outcomes:
measure: Change in physical capability outcomes (6 minute walk; squats; light board game task standing bent forward /kneeling; floor-to-waist lift; horizontal lift; static push/pull force)
timeFrame: pre-op, at 6mo., and at 12mo.
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: pre-op, at 6mo., and at 12mo
measure: EQ-5D Health Questionnaire
timeFrame: pre-op, at 6mo., and at 12mo.
measure: Visual Analog Scale (VAS) scores for pain severity and frequency
timeFrame: pre-op, at 6mo., and at 12mo.
measure: SF-36 scores for the 8 Domains
timeFrame: pre-op, at 6mo., and at 12mo.
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Newark
country: United States
facility: Christiana Spine Center
state: Delaware
city: Tallahassee
country: United States
facility: Capital Regional Medical Center
state: Florida
city: Marquette
country: United States
facility: Orthopaedic Surgery Associates of Marquette, PC
state: Michigan
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: La Crosse
country: United States
facility: Gundersen Lutheran Health System
state: Wisconsin
Study officials:
affiliation: Gundersen Lutheran Health System, LaCrosse, WI
name: Humbert (Drew) G Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Back Institute, Plano, TX
name: Jack E Zigler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eisenhower Army Medical Center, Augusta, GA
name: John G Devine, MD
role: PRINCIPAL_INVESTIGATOR
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