CompletedNot Applicable

MLX/XLX ACR Expandable Lumbar Interbody Implants

United States109 participantsStarted 2020-01-27

Plain-language summary

The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiographic outcomes, and clinical patient outcomes. This study is being undertaken to identify possible residual risks and to clarify mid- to long-term clinical performance that may affect the benefit/risk ratios of the MLX and XLX ACR interbody implants.

Who can participate

Age range

18 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

. Patients who were ≥18 years of age at the time of surgery
. Underwent spine surgery using either MLX or XLX ACR interbody implant (NuVasive, Inc., San Diego, CA) at:
. One or two adjacent thoracic and/or lumbar levels for degenerative disc disease or degenerative spondylolisthesis, or
. Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined as \>10º coronal curve)
. Interbody fusion with autograft and/or allograft (i.e., cancellous and/or corticocancellous allograft bone)
. NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the thoracolumbar spine

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

Rate of Complications

Timeframe: At least three months

Proportion of Subjects with Improvement in Neurological Symptoms

Timeframe: At least three months

Trial details

NCT IDNCT04420143

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-10-23

View on ClinicalTrials.gov More Degenerative Disc Disease trials