MLX/XLX ACR Expandable Lumbar Interbody Implants

Completed

• Conditions: Spondylolisthesis; Degenerative Disc Disease; Degenerative Scoliosis

• Registration Number: NCT04420143
• Lead Sponsor: NuVasive

Brief Summary

The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiographic outcomes, and clinical patient outcomes. This study is being undertaken to identify possible residual risks and to clarify mid- to long-term clinical performance that may affect the benefit/risk ratios of the MLX and XLX ACR interbody implants.

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 with surgeries that meet eligibility requirements will be included in the study and available progress notes, medical records, patient-reported outcomes (PROs), radiographs, and complications will be obtained from the medical records.

The safety and performance of the MLX and XLX ACR interbody implants will be assessed using the following:

1. Complications attributable to the use of the associated interbody implant as noted in surgical summaries, progress notes, and hospital records

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

3. Radiographic outcome (fusion) and description of device status from plain film radiographs and computed tomography (CT) scan(s), as available

Study Timeline

• Study Start: 2020-01-27
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Primary Completion: 2020-10-23
• Study Completion: 2020-10-23
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

1. Patients who were ≥18 years of age at the time of surgery

2. Underwent spine surgery using either MLX or XLX ACR interbody implant (NuVasive, Inc., San Diego, CA) at:

   1. One or two adjacent thoracic and/or lumbar levels for degenerative disc disease or degenerative spondylolisthesis, or
   2. Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined as >10º coronal curve)

3. Interbody fusion with autograft and/or allograft (i.e., cancellous and/or corticocancellous allograft bone)

4. NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the thoracolumbar spine

Exclusion Criteria

1. Use of any bone graft with the associated interbody implant that is not FDA-cleared for use within interbody implants.

   Examples of these include:

   1. Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
   2. 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))
   3. 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))
   4. Peptide enhanced bone graft (e.g., iFactor (Cerapedics))

2. Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable)

3. Systemic or local infection (latent or active) or signs of local inflammation documented at the time of surgery

4. Patient was involved in active litigation relating to the spine during the surgical/postoperative period (worker's compensation claim is allowed if it is not contested)

5. Inadequate bone stock or bone quality documented at the time of surgery

6. Known sensitivity to materials implanted documented at the time of surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Complications	At least three months	Rate of complications (i.e., safety) attributable to use of the associated interbody implants (MLX or XLX ACR)
Proportion of Subjects with Improvement in Neurological Symptoms	At least three months	The rate of improvement as compared to baseline in preoperative neurological symptoms will be measured using a standard motor/sensory neurological exam.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects with Apparent Radiographic Fusion	12 months or greater	Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative, as imaging is available

Trial Locations

Locations (4)

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States

Orthopaedic Specialty Institute; 🇺🇸 Orange, California, United States

Lyerly Neurosurgery; 🇺🇸 Jacksonville, Florida, United States

Carolina NeuroSurgery & Spine Associates; 🇺🇸 Charlotte, North Carolina, United States