TerminatedNot Applicable

AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY

Stopped: Lack of subject enrollment

United States9 participantsStarted 2016-06-08

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.

Timeframe: 24 months

Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.

Timeframe: 24 months

Trial details

NCT IDNCT02704689

SponsorVB Spine, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-01-19

Results submitted2018-03-22

View on ClinicalTrials.gov More Degenerative Disc Disease trials