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

September 8, 2011 updated by: Humbert (Drew) Sullivan, Gundersen Lutheran Medical Foundation

Physical Capability Outcomes After Single-Level ProDisc-L Total Disc Replacement or Single-Level Anterior Lumbar Interbody Fusion: a Multi-Center Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States
        • University of Colorado Denver
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Spine Center
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Capital Regional Medical Center
    • Michigan
      • Marquette, Michigan, United States, 49855
        • Orthopaedic Surgery Associates of Marquette, PC
    • Texas
      • Plano, Texas, United States, 75093
        • Texas Back Institute
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
pre-op, at 6mo., and at 12mo.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Oswestry Disability Index
Time Frame: pre-op, at 6mo., and at 12mo
pre-op, at 6mo., and at 12mo
EQ-5D Health Questionnaire
Time Frame: pre-op, at 6mo., and at 12mo.
pre-op, at 6mo., and at 12mo.
Visual Analog Scale (VAS) scores for pain severity and frequency
Time Frame: pre-op, at 6mo., and at 12mo.
pre-op, at 6mo., and at 12mo.
SF-36 scores for the 8 Domains
Time Frame: pre-op, at 6mo., and at 12mo.
pre-op, at 6mo., and at 12mo.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gundersen Lutheran Medical Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Synthes USA HQ, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2-09-05-002
  • 20092359 (Other Identifier: Western Institutional Review Board (WIRB))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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