Retrospective Modulus ALIF Study

Completed

• Conditions: Spondylolisthesis; Degenerative Disc Disease; Stenosis
• Interventions: Device: Modulus ALIF System

• Registration Number: NCT05566704
• Lead Sponsor: NuVasive

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.

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:

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

Study Timeline

• Study Start: 2022-08-18
• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Primary Completion: 2022-10-15
• Study Completion: 2024-05-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Modulus ALIF System	Modulus ALIF System	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (5)

Hoag Orthopedics; 🇺🇸 Orange, California, United States

Girard Orthopedic Surgeons; 🇺🇸 San Diego, California, United States

Atlantic Brain and Spine; 🇺🇸 Wilmington, North Carolina, United States

Georgia Spine & Neurosurgery Center; 🇺🇸 Atlanta, Georgia, United States

OrthoCarolina; 🇺🇸 Charlotte, North Carolina, United States