MLX/XLX ACR Expandable Lumbar Interbody Implants

NCT04420143 | Completed

• 1 other identifier: NUVA.EXP0120
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 4

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.

Conditions

Spondylolisthesis; Degenerative Scoliosis; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (2)

• Rate of Complications

  Rate of complications (i.e., safety) attributable to use of the associated interbody implants (MLX or XLX ACR)

  At least three months

• Proportion of Subjects with Improvement in Neurological Symptoms

  The rate of improvement as compared to baseline in preoperative neurological symptoms will be measured using a standard motor/sensory neurological exam.

  At least three months

Secondary Outcomes (1)

• Proportion of Subjects with Apparent Radiographic Fusion

  12 months or greater

Study Arms (2)

MLX - Medial Lateral Expandable Lumbar Interbody System

Patients who underwent lumbar interbody fusion with the MLX expandable interbody implant will be included in the MLX - Medial Lateral Expandable Lumbar Interbody System cohort.

XLX ACR Interbody System

Patients who underwent lumbar interbody fusion with the XLX ACR expandable interbody implant will be included in the XLX ACR Interbody System cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least 90 (75 MLX, 15 XLX ACR) subjects will be enrolled in this multicenter study by at least four investigative sites. A site may have more than one surgeon investigator contributing to the total site enrollment. As a retrospective study, enrollment goals will be determined with the surgeon investigator during site selection by the Sponsor and will be based on available case volume. The site will identify potential subjects who are more than three months from the surgery postoperative time point during the study duration for inclusion in the study.

You may qualify if:

• Patients who were ≥18 years of age at the time of surgery
• Underwent spine surgery using either MLX or XLX ACR interbody implant (NuVasive, Inc., San Diego, CA) at:
• One or two adjacent 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 (i.e., cancellous and/or corticocancellous allograft bone)
• NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the thoracolumbar spine

You may not qualify if:

• Use of any bone graft with the associated interbody implant that is not FDA-cleared for use within interbody implants.
• 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)
• Systemic or local infection (latent or active) or signs of local inflammation documented at the time of surgery
• 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)
• Inadequate bone stock or bone quality documented at the time of surgery
• Known sensitivity to materials implanted documented at the time of surgery

Sponsors & Collaborators

• NuVasive: lead

Study Sites (4)

Orthopaedic Specialty Institute

Orange, California, 92868, United States

Location

Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

Carolina NeuroSurgery & Spine Associates

Charlotte, North Carolina, 28204, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Kyle Malone, MS

  NuVasive

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: January 27, 2020
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (4)