Modulus in XLIF Study

Sponsor

NuVasive (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04418817

Collaborator

(none)

Enrollment

Locations

27.3

Anticipated Duration (Months)

37.5

Patients Per Site

1.4

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 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications, radiographic outcomes, and patient-reported outcomes.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease Degenerative Spondylolisthesis Degenerative Scoliosis

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 asked to consent to participate in the study. Once enrolled in the study, subjects will undergo a computed tomography (CT) scan at 12 months postoperative or later to evaluate their fusion status. If the patient already had a postoperative CT scan at 12 months or greater, this will be used in this study and an additional CT scan should not be performed for this 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 safety and performance of the Modulus XLIF interbody implant will be assessed using the following:

Complications attributable to the use of the Modulus XLIF interbody implant as noted in surgical summaries, progress notes, and hospital records
Radiographic outcome (fusion) and description of device status from plain film radiographs and CT scan(s)
Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

An Assessment of the Safety and Performance of the Modulus® 3D-printed Titanium Interbody Implant in Patients Undergoing eXtreme Lateral Interbody Fusion (XLIF®)

Actual Study Start Date :

Mar 22, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Modulus XLIF Interbody System

Outcome Measures

Primary Outcome Measures

Rate of Complications [At least 12 months]
Rate of complications attributable to use of the Modulus XLIF interbody implant
Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative [At least 12 months]
Proportion of subjects with fusion at 12 months or greater

Secondary Outcome Measures

Improvement in neurologic status [At least 12 months]
Proportion of subjects with neurological improvement as compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients who are ≥18 years of age at the time of surgery
Treated with XLIF procedure with the Modulus 3D-printed titanium interbody implant at:
One or two thoracic and/or lumbar levels for degenerative disc disease or degenerative spondylolisthesis, or
Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined as >10º coronal curve)
Interbody fusion with autograft and/or allograft
Any NuVasive supplemental fixation
Patient is able and to undergo a CT scan. If the patient already had a postoperative CT scan at 12 months or greater, this will be used in this study and an additional CT scan should not be performed for this study.
Patient understands the conditions of enrollment and is willing to sign an informed consent form to participate.

Exclusion Criteria:

Use of any bone graft with the Modulus XLIF interbody implant that is not FDA-cleared for use in the interbody space. Examples of these include:
Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
Synthetic bone graft extenders (e.g., AttraX (NuVasive), Formagraft (NuVasive), Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss (RTI Surgical), Fibergraft (Prosidyan/Depuy Synthes), ChronOs (Depuy Synthes))
Demineralized bone matrices (DBM) regulated as medical devices by the FDA (e.g., Grafton Putty/Gel (Medtronic), DBX (MTF/Depuy Synthes), Accell Evo3 (IsoTis), Propel Putty/Gel (NuVasive))
Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable)
Patients with active infection at the surgical site at the time of surgery
Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
Patient is unwilling or unable to undergo a CT scan due to pregnancy or other medical condition
Patient is a prisoner
Patient is participating in another clinical study that would confound study data

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erik C. Spayde, MD Inc.	Thousand Oaks	California	United States	91360
2	Georgia Spine & Neurosurgery Center	Atlanta	Georgia	United States	30342

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:

NCT04418817

Other Study ID Numbers:

NUVA.X1901

First Posted:

Jun 5, 2020

Last Update Posted:

Jul 20, 2021

Last Verified:

Jul 1, 2021

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

Additional relevant MeSH terms:

Scoliosis

Intervertebral Disc Degeneration

Spondylolisthesis

Study Results

No Results Posted as of Jul 20, 2021