Degenerative Disc DiseaseNCT04420143
MLX/XLX ACR Expandable Lumbar Interbody Implants
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by NuVasive at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Degenerative Scoliosis
- How many people
- 109 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Jan 2020to 23 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Use of any bone graft with the associated interbody implant that is not FDA-cleared for use within interbody implants.
- Examples of these include:
- Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
- 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))
- 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))
- Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
Show all 11Show fewer
- Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable)
- Systemic or local infection (latent or active) or signs of local inflammation documented at the time of surgery
- 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)
- Inadequate bone stock or bone quality documented at the time of surgery
- Known sensitivity to materials implanted documented at the time of surgery
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Carolina NeuroSurgery & Spine Associates
Charlotte, North Carolina, 28204
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Lyerly Neurosurgery
Jacksonville, Florida, 32207
Orthopaedic Specialty Institute
Orange, California, 92868
About this study
Official title: An Assessment of the Safety and Performance of the MLX® Medial Lateral and XLX ACR® Expandable Lumbar Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Thoracic and/or Lumbar Spine
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.
Read the detailed description
Patients considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. All patients at a given site with surgeries that meet eligibility requirements will be included in the study and available progress notes, medical records, patient-reported outcomes (PROs), radiographs, and complications will be obtained from the medical records.
The safety and performance of the MLX and XLX ACR interbody implants will be assessed using the following:
- Complications attributable to the use of the associated interbody implant as noted in surgical summaries, progress notes, and hospital records
- Neurologic status, symptoms, and subject self-reported clinical outcomes (e.g., pain and disability), as available
- Radiographic outcome (fusion) and description of device status from plain film radiographs and computed tomography (CT) scan(s), as available
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MLX - Medial Lateral Expandable Lumbar Interbody System | Patients who underwent lumbar interbody fusion with the MLX expandable interbody implant will be included in the MLX - Medial Lateral Expandable Lumbar Interbody System cohort. | |
| XLX ACR Interbody System | Patients who underwent lumbar interbody fusion with the XLX ACR expandable interbody implant will be included in the XLX ACR Interbody System cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complications
Rate of complications (i.e., safety) attributable to use of the associated interbody implants (MLX or XLX ACR)
Measured: At least three months
Proportion of Subjects with Improvement in Neurological Symptoms
The rate of improvement as compared to baseline in preoperative neurological symptoms will be measured using a standard motor/sensory neurological exam.
Measured: At least three months
Secondary outcomes (1)
Proportion of Subjects with Apparent Radiographic Fusion
Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative, as imaging is available
Measured: 12 months or greater
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start27 Jan 2020
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Malone, MS, Study director, NuVasive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420143
- Sponsor's protocol ID
- NUVA.EXP0120
- Status last verified
- Dec 2025
- First submitted
- 2 Jun 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Safety and Performance of the MLX® Medial Lateral and XLX ACR® Expandable Lumbar Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Thoracic and/or Lumbar Spine
- ClinicalTrials.gov ID
- NCT04420143
- Acronym / sponsor ID
- NUVA.EXP0120
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. All patients at a given site with surgeries that meet eligibility requirements will be included in the study and available progress notes, medical records, patient-reported outcomes (PROs), radiographs, and complications will be obtained from the medical records.
The safety and performance of the MLX and XLX ACR interbody implants will be assessed using the following:
- Complications attributable to the use of the associated interbody implant as noted in surgical summaries, progress notes, and hospital records
- Neurologic status, symptoms, and subject self-reported clinical outcomes (e.g., pain and disability), as available
- Radiographic outcome (fusion) and description of device status from plain film radiographs and computed tomography (CT) scan(s), as available
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MLX - Medial Lateral Expandable Lumbar Interbody System | – | –Patients who underwent lumbar interbody fusion with the MLX expandable interbody implant will be included in the MLX - Medial Lateral Expandable Lumbar Interbody System cohort. |
| XLX ACR Interbody System | – | –Patients who underwent lumbar interbody fusion with the XLX ACR expandable interbody implant will be included in the XLX ACR Interbody System cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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:
- 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
Key exclusion criteria (11 listed)
- Use of any bone graft with the associated interbody implant that is not FDA-cleared for use within interbody implants.
- Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable)
- Systemic or local infection (latent or active) or signs of local inflammation documented at the time of surgery
- 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)
- Inadequate bone stock or bone quality documented at the time of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Complications
Time frame: At least three months
Rate of complications (i.e., safety) attributable to use of the associated interbody implants (MLX or XLX ACR)
Proportion of Subjects with Improvement in Neurological Symptoms
Time frame: At least three months
The rate of improvement as compared to baseline in preoperative neurological symptoms will be measured using a standard motor/sensory neurological exam.
1 secondary outcome
Proportion of Subjects with Apparent Radiographic Fusion
Time frame: 12 months or greater
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Malone, MS study director
NuVasive
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by NuVasive at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complications (time frame: At least three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.