Retrospective Modulus ALIF Study

Sponsor

NuVasive (Industry)

Overall Status

Completed

CT.gov ID

NCT05566704

Collaborator

(none)

123

Enrollment

Locations

4.4

Actual Duration (Months)

Patients Per Site

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease Spondylolisthesis Stenosis	Device: Modulus ALIF System

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

Study Type:

Observational

Actual Enrollment :

123 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

An Assessment of the Safety and Performance of the Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion

Actual Study Start Date :

Aug 18, 2022

Actual Primary Completion Date :

Oct 15, 2022

Actual Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Modulus ALIF System	Device: Modulus ALIF System 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.

Arm

Intervention/Treatment

Modulus ALIF System

Device: Modulus ALIF System

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.

Outcome Measures

Primary Outcome Measures

Rates of complications attributable to the use of the Modulus ALIF System [12 months]
Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative [12 months]

Secondary Outcome Measures

Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

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°

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Girard Orthopedic Surgeons	San Diego	California	United States	92121
2	Georgia Spine & Neurosurgery Center	Atlanta	Georgia	United States	30342
3	Atlantic Brain and Spine	Wilmington	North Carolina	United States	28401

Sponsors and Collaborators

NuVasive

Investigators

Study Director: Kyle Malone, MS, NuVasive

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NuVasive

ClinicalTrials.gov Identifier:

NCT05566704

Other Study ID Numbers:

NUVA.RMA0222

First Posted:

Oct 4, 2022

Last Update Posted:

Jan 13, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Intervertebral Disc Degeneration

Spondylolisthesis

Study Results

No Results Posted as of Jan 13, 2023