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Physical Capability Outcomes After Single-Level PD-L vs Single-Level ALIF: a Multi-Center Clinical Trial

This study has been terminated.
(Unanticipated study design flaw; PCO evaluator interrater reliability was not performed.)
Sponsor:
Collaborator:
Synthes USA HQ, Inc.
Information provided by (Responsible Party):
Humbert (Drew) Sullivan, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier:
NCT01055574
First received: January 22, 2010
Last updated: September 8, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition
Physical Capability Outcomes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Gundersen Lutheran Medical Foundation:

Primary Outcome Measures:
  • 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) [ Time Frame: pre-op, at 6mo., and at 12mo. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: pre-op, at 6mo., and at 12mo ] [ Designated as safety issue: No ]
  • EQ-5D Health Questionnaire [ Time Frame: pre-op, at 6mo., and at 12mo. ] [ Designated as safety issue: No ]
  • Visual Analog Scale (VAS) scores for pain severity and frequency [ Time Frame: pre-op, at 6mo., and at 12mo. ] [ Designated as safety issue: No ]
  • SF-36 scores for the 8 Domains [ Time Frame: pre-op, at 6mo., and at 12mo. ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: October 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
ProDisc-L
Subjects who received single-level ProDisc-L total disc replacement prior to physical capability evaluations
anterior lumbar interbody fusion (AILF)
Subjects who received single-level anterior lumbar interbody fusion prior to physical capability evaluations

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055574

Locations
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States
United States, Delaware
Christiana Spine Center
Newark, Delaware, United States, 19713
United States, Florida
Capital Regional Medical Center
Tallahassee, Florida, United States, 32308
United States, Michigan
Orthopaedic Surgery Associates of Marquette, PC
Marquette, Michigan, United States, 49855
United States, Texas
Texas Back Institute
Plano, Texas, United States, 75093
United States, Wisconsin
Gundersen Lutheran Health System
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Gundersen Lutheran Medical Foundation
Synthes USA HQ, Inc.
Investigators
Principal Investigator: Humbert (Drew) G Sullivan, MD Gundersen Lutheran Health System, LaCrosse, WI
Principal Investigator: Jack E Zigler, MD Texas Back Institute, Plano, TX
Principal Investigator: John G Devine, MD Eisenhower Army Medical Center, Augusta, GA
  More Information

Publications:

Responsible Party: Humbert (Drew) Sullivan, Chair, Department of Neurosurgery, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier: NCT01055574     History of Changes
Other Study ID Numbers: 2-09-05-002, 20092359
Study First Received: January 22, 2010
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Gundersen Lutheran Medical Foundation:
lumbar disc arthroplasty
total disc replacement
ProDisc L
anterior lumbar interbody fusion
lumbar spine surgery outcomes

ClinicalTrials.gov processed this record on May 16, 2013