Retrospective Modulus ALIF Study

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05566704
• Other study ID #: NUVA.RMA0222
• Status: Completed
• Start date: August 18, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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:

1. Complications attributable to the use of the Modulus ALIF System as noted in surgical summaries, progress notes, and hospital records; and

2. Radiographic outcome (fusion) and description of device status from available plain film radiographs and CT scan(s); and

3. Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 1, 2024
• Est. primary completion date: October 15, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery

2. Male or female patients who are =18 years of age at the time of surgery

3. 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

4. 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

5. 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:

1. Patient was a prisoner at the time of Modulus ALIF treatment

2. Patient was participating in another clinical study during treatment that would confound study data

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spondylolisthesis
• Stenosis

Intervention

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.

Locations

Country	Name	City	State
United States	Georgia Spine & Neurosurgery Center	Atlanta	Georgia
United States	OrthoCarolina	Charlotte	North Carolina
United States	Hoag Orthopedics	Orange	California
United States	Girard Orthopedic Surgeons	San Diego	California
United States	Atlantic Brain and Spine	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of complications attributable to the use of the Modulus ALIF System		12 months
Primary	Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative		12 months
Secondary	Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available		12 months