NanoFUSE® PL Gutter PMCF

Study Overview
=================
Brief Summary
-----------------
This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.

Detailed Description
-----------------
NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis.) These defects may be surgically created osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine. This product provides a bone graft substitute that remodels into the recipient's skeletal system. Radiographic success will be the primary judgement of success. All patient's achieving fused or probably fused status will be judged as a success.

Official Title
-----------------
Clinical Investigation of NanoFUSE® Bioactive Matrix and Autogenous Bone in Posterolateral Spinal Fusion (Nonloadbearing)

Conditions
-----------------
Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grade I or II (less than 50% slip f the cephalic vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5 Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of nonsurgical treatment, or such patients with worsening neurological condition Patients who are medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix is consistent with product labeling Patients who have consented for surgical treatment Patients able to provide informed consent for the study and complete the questionnaires Exclusion Criteria: Lytic spondylolisthesis Non degenerative stenosis (example: tumor, trauma, epidural, lipomatosis) Segmental kyphosis at the level of the spondylolisthesis Rheumatoid arthritis Active infection On long term disability or workers compensation claim

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NanoFuse® PL Gutter<br>NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral) | Device: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)<br>* NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Success | All patients achieving fused or probably fused status will be judged as successes at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall patient success | Overall patient success will be based on all clinical and radiographic evaluation parameters and complications for the indication for use. Success criteria includes the following: Presence of radiographic fusion as evidenced by identification of new bone mass No hardware failure or screw blackout Decreased level of pain (VAS) Maintained or improved level of function (ODI) Maintained or improved neurological status | 12 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Demineralized Bone Matrix, Primary Lumbar Fusion, Autograft Lumbar Fusion