Clinical trial NCT05566704: Retrospective Modulus ALIF Study
Official title: An Assessment of the Safety and Performance of the Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Spondylolisthesis
Stenosis
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2022-10-04
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Rates of complications attributable to the use of the Modulus ALIF System
timeFrame: 12 months
measure: Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative
timeFrame: 12 months
Secondary outcomes:
measure: Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
timeFrame: 12 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: Hoag Orthopedics
state: California
city: San Diego
country: United States
facility: Girard Orthopedic Surgeons
state: California
city: Atlanta
country: United States
facility: Georgia Spine & Neurosurgery Center
state: Georgia
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Wilmington
country: United States
facility: Atlantic Brain and Spine
state: North Carolina
Study officials:
affiliation: Globus Medical
name: Kyle Malone, MS
role: STUDY_DIRECTOR
References: