MLX/XLX ACR Expandable Lumbar Interbody Implants

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04420143
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NuVasive
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kyle Malone, MS
Principal Investigator Affiliation NuVasive
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease, Spondylolisthesis, Degenerative Scoliosis
Additional Details

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

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orthopaedic Specialty Institute, Orange, California

Status

Address

Orthopaedic Specialty Institute

Orange, California, 92868

Lyerly Neurosurgery, Jacksonville, Florida

Status

Address

Lyerly Neurosurgery

Jacksonville, Florida, 32207

Carolina NeuroSurgery & Spine Associates, Charlotte, North Carolina

Status

Address

Carolina NeuroSurgery & Spine Associates

Charlotte, North Carolina, 28204

OrthoCarolina Research Institute, Charlotte, North Carolina

Status

Address

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207