AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY

Stopped early · Not applicable

Conditions studied: Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis

In brief

This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1.

Key facts

Study ID

NCT02704689

Run by

VB Spine, LLC

People needed

9

Starts

2016-06-08

Expected to finish

2017-01-19

Last updated by the study team

2018-04-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is skeletally mature and between 18 and 70 years of age.
• DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1.
• No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
• Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
• Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.
• Subject agrees to comply with visit schedule and completing study questionnaires.

You may not qualify if…

• Significant instability of the spine.
• Requires TLIF at more than 2 levels between L2 and S1.
• Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.
• Younger than 18 years of age, or older than 70 years of age.
• BMI of 40 or greater.
• History of metabolic bone disease
• Osteoporosis
• Diabetes mellitus requiring daily insulin management.
• Subject has any of the following:
• Progressive neuromuscular disease; OR
• Autoimmune disease; OR
• Active malignancy within the last 15 years; OR
• Active hepatitis; OR
• AIDS, ARC, or is HIV positive; OR
• Syringomyelia at any spinal level; OR
• Any other condition that would interfere with the subject self -assessment of pain, function or quality of life.
• Allergy to implant materials (titanium, titanium alloy).
• Active systemic infection or infection localized to the site of implantation.
• Primary or metastatic tumors involving the spine.
• Open wounds or inadequate issue tissue coverage over the operative site.
• History of significant mental illness or mental incapacity.
• Pregnancy or intent to become pregnant.
• Participating in another investigational study for a similar purpose.
• Belongs to a vulnerable population that would compromise ability to provide informed consent or compliance with follow-up requirements.
• Smokers unwilling to cease up to 3 months post-op or recent history of alcohol or other substance abuse within the past 2 years.

Where it is running

• University of Missouri Health Care — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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