Degenerative Disc DiseaseNCT05566704
Retrospective Modulus ALIF Study
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by NuVasive at 5 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Stenosis
- What is being tested?
- Modulus ALIF System
- Type of treatment
- Medical device
- How many people
- 123 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Aug 2022to 1 May 2024
- 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
- Adult, Older adult
Study population: The analysis population will include all subjects who meet the criteria for enrollment, specifically, those subjects who: * Satisfied the inclusion and exclusion criteria * Previously underwent the surgical procedure as defined in this protocol
Who may be able to join
- Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery
- Male or female patients who are ≥18 years of age at the time of surgery
- Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome
- Treated with ALIF procedure with the Modulus ALIF System at:
- One or two adjacent lumbar and/or lumbosacral levels for degenerative disc disease (DDD), degenerative spondylolisthesis, or spinal stenosis, or
- Any number of lumbar and/or lumbosacral levels for degenerative scoliosis (defined as >10º coronal curve) or sagittal deformity
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- Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:
- 1-2 levels treated for DDD, and
- 3 or 4 interfixated screws placed, and
- Implant lordosis is ≤20°
Who cannot join
- Patient was a prisoner at the time of Modulus ALIF treatment
- Patient was participating in another clinical study during treatment that would confound study data
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Georgia Spine & Neurosurgery Center
Atlanta, Georgia, 30342
OrthoCarolina
Charlotte, North Carolina, 28207
Hoag Orthopedics
Orange, California, 92868
Girard Orthopedic Surgeons
San Diego, California, 92121
Atlantic Brain and Spine
Wilmington, North Carolina, 28401
About this study
Official title: An Assessment of the Safety and Performance of the Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion
The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.
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 who meet eligibility requirements will be considered for participation in the study. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects.
The complication profile and overall performance of the Modulus ALIF System will be assessed using the following:
- Complications attributable to the use of the Modulus ALIF System as noted in surgical summaries, progress notes, and hospital records; and
- Radiographic outcome (fusion) and description of device status from available plain film radiographs and CT scan(s); and
- Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Stenosis
- Being tested
- Modulus ALIF System
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modulus ALIF SystemDevice
The Modulus ALIF System is designed to address lumbar pathologies utilizing interbody placement through an anterior or anterolateral surgical approach. The Modulus ALIF System is an interfixated interbody system available in various shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Modulus ALIF System | Not described Receives: Device: Modulus ALIF System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of complications attributable to the use of the Modulus ALIF System
Measured: 12 months
Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative
Measured: 12 months
Secondary outcomes (1)
Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start18 Aug 2022
- Primary completion15 Oct 2022
- Study completion1 May 2024
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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Malone, MS, Study director, Globus Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566704
- Sponsor's protocol ID
- NUVA.RMA0222
- Status last verified
- Dec 2025
- First submitted
- 30 Sep 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT05566704
- Acronym / sponsor ID
- NUVA.RMA0222
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 4 Oct 2022 (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 primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.
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 who meet eligibility requirements will be considered for participation in the study. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects.
The complication profile and overall performance of the Modulus ALIF System will be assessed using the following:
- Complications attributable to the use of the Modulus ALIF System as noted in surgical summaries, progress notes, and hospital records; and
- Radiographic outcome (fusion) and description of device status from available plain film radiographs and CT scan(s); and
- Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modulus ALIF System | – | Device: Modulus ALIF System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The analysis population will include all subjects who meet the criteria for enrollment, specifically, those subjects who: * Satisfied the inclusion and exclusion criteria * Previously underwent the surgical procedure as defined in this protocol
Key inclusion criteria (10 listed)
- Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery
- Male or female patients who are ≥18 years of age at the time of surgery
- Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome
- Treated with ALIF procedure with the Modulus ALIF System at:
- Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:
Key exclusion criteria (2 listed)
- Patient was a prisoner at the time of Modulus ALIF treatment
- Patient was participating in another clinical study during treatment that would confound study data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modulus ALIF SystemThe Modulus ALIF System is designed to address lumbar pathologies utilizing interbody placement through an anterior or anterolateral surgical approach. The Modulus ALIF System is an interfixated interbody system available in various shapes and sizes to suit the individual pathology and anatomical conditions of the patient. | Device | Modulus ALIF System |
Primary outcome
Rates of complications attributable to the use of the Modulus ALIF System
Time frame: 12 months
Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative
Time frame: 12 months
1 secondary outcome
Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
Time frame: 12 months
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
Globus Medical
5 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 5 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 10 inclusion and 2 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 5 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?
Rates of complications attributable to the use of the Modulus ALIF System (time frame: 12 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.