Degenerative Disc Disease Clinical Trial
Official title:
An Assessment of the Safety and Performance of the MLX® Medial Lateral and XLX ACR® Expandable Lumbar Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Thoracic and/or Lumbar Spine
Verified date | August 2021 |
Source | NuVasive |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 109 |
Est. completion date | October 23, 2020 |
Est. primary completion date | October 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Carolina NeuroSurgery & Spine Associates | Charlotte | North Carolina |
United States | OrthoCarolina Research Institute | Charlotte | North Carolina |
United States | Lyerly Neurosurgery | Jacksonville | Florida |
United States | Orthopaedic Specialty Institute | Orange | California |
Lead Sponsor | Collaborator |
---|---|
NuVasive |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Proportion of Subjects with Apparent Radiographic Fusion | Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative, as imaging is available | 12 months or greater |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Active, not recruiting |
NCT05114135 -
TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)
|
N/A | |
Suspended |
NCT04735185 -
Stem Cells vs. Steroids for Discogenic Back Pain
|
N/A | |
Withdrawn |
NCT03223701 -
Efficacy of Using Solum IV and BMC With GFC in TLIF
|
Phase 4 | |
Completed |
NCT04057235 -
Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
|
||
Not yet recruiting |
NCT06000319 -
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
|
||
Active, not recruiting |
NCT02969616 -
Trinity Elite in Lumbar Fusion
|
||
Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
Completed |
NCT02104167 -
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
|
||
Completed |
NCT00965380 -
Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
|
||
Completed |
NCT00996073 -
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
|
Phase 2 | |
Terminated |
NCT00974623 -
Bone Graft Materials Observational Registry
|
N/A | |
Completed |
NCT00758719 -
Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
|
||
Completed |
NCT00165893 -
Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease
|
Phase 4 | |
Terminated |
NCT01494493 -
Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
|
N/A | |
Recruiting |
NCT04727385 -
Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease
|
N/A | |
Completed |
NCT04849429 -
Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain
|
Phase 1 | |
Recruiting |
NCT04469387 -
Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion
|
N/A | |
Recruiting |
NCT04056520 -
Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
|
||
Completed |
NCT04119466 -
Stabilizing Training in Degenerative Disc Disease
|
N/A |