CompletedNot Applicable

Modulus in XLIF Study

United States36 participantsStarted 2020-03-22

Plain-language summary

The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications, radiographic outcomes, and patient-reported outcomes.

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

. Male or female patients who are ≥18 years of age at the time of surgery
. Treated with XLIF procedure with the Modulus 3D-printed titanium interbody implant at:
. One or two 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
. Any NuVasive supplemental fixation
. Patient is able and to undergo a CT scan. If the patient already had a postoperative CT scan at 12 months or greater, this will be used in this study and an additional CT scan should not be performed for this study.
. Patient understands the conditions of enrollment and is willing to sign an informed consent form to participate.

Exclusion criteria

. Use of any bone graft with the Modulus XLIF interbody implant that is not FDA-cleared for use in the interbody space. Examples of these include:

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 12 months

Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative

Timeframe: At least 12 months

Trial details

NCT IDNCT04418817

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-01-31

View on ClinicalTrials.gov More Degenerative Disc Disease trials