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

Stopped early

Conditions studied: Physical Capability Outcomes

In brief

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.

Key facts

Study ID

NCT01055574

Run by

Gundersen Lutheran Medical Foundation

People needed

45

Starts

2009-10-01

Expected to finish

2012-01-01

Last updated by the study team

2011-09-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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