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New spine implants tested for safety in patients with back problems

NCT ID NCT04420143

Disease control Sponsor: NuVasive Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the safety and performance of two types of expandable spine implants (MLX and XLX ACR) in 109 adults with degenerative disc disease, spondylolisthesis, or scoliosis. Researchers tracked complications, bone fusion, and improvement in nerve symptoms after surgery. The goal was to understand how well these implants work over the medium to long term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
expandable lumbar interbody implants (MLX and XLX ACR)
What this could lead to
If successful, this could confirm that these implants are safe and effective for treating degenerative spine conditions, offering a surgical option to reduce pain and improve function.
What could go wrong
This is a completed study with only 109 participants and no comparison group, so results may not apply to all patients. Risks include complications from surgery and implant failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

109 people

The number who actually took part.

Started

Jan 2020

Finished

Oct 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

At least 90 (75 MLX, 15 XLX ACR) subjects will be enrolled in this multicenter study by at least four investigative sites. A site may have more than one surgeon investigator contributing to the total site enrollment. As a retrospective study, enrollment goals will be determined with the surgeon investigator during site selection by the Sponsor and will be based on available case volume. The site will identify potential subjects who are more than three months from the surgery postoperative time point during the study duration for inclusion in the study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who were ≥18 years of age at the time of surgery 2. Underwent spine surgery using either MLX or XLX ACR interbody implant (NuVasive, Inc., San Diego, CA) at: 1. One or two adjacent thoracic and/or lumbar levels for degenerative disc disease or degenerative spondylolisthesis, or 2. Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined as \>10º coronal curve) 3. Interbody fusion with autograft and/or allograft (i.e., cancellous and/or corticocancellous allograft bone) 4. NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the thoracolumbar spine Exclusion Criteria: 1. Use of any bone graft with the associated interbody implant that is not FDA-cleared for use within interbody implants. Examples of these include: 1. Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic)) 2. Synthetic bone graft extenders (e.g., AttraX (NuVasive), Formagraft (NuVasive), Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss (RTI Surgical), Fibergraft (Prosidyan/Depuy Synthes), ChronOs (Depuy Synthes)) 3. Demineralized bone matrices (DBM) regulated as medical devices by the FDA (e.g., Grafton Putty/Gel (Medtronic), DBX (MTF/Depuy Synthes), Accell Evo3 (IsoTis), Propel Putty/Gel (NuVasive)) 4. Peptide enhanced bone graft (e.g., iFactor (Cerapedics)) 2. Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable) 3. Systemic or local infection (latent or active) or signs of local inflammation documented at the time of surgery 4. Patient was involved in active litigation relating to the spine during the surgical/postoperative period (worker's compensation claim is allowed if it is not contested) 5. Inadequate bone stock or bone quality documented at the time of surgery 6. Known sensitivity to materials implanted documented at the time of surgery

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder scoliosis spondylolisthesis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative disc disease Degenerative scoliosis Spondylolisthesis

Contacts and locations

Locations

  • Carolina NeuroSurgery & Spine Associates

    Charlotte, North Carolina, 28204, United States

  • Lyerly Neurosurgery

    Jacksonville, Florida, 32207, United States

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207, United States

  • Orthopaedic Specialty Institute

    Orange, California, 92868, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.