Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use.

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 or osseous defects created from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. This product provides a bone graft substitute that remodels into the recipient's skeletal system.

Official Title
-----------------
Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix

Conditions
-----------------
Bone; Degeneration

Intervention / Treatment
-----------------
* Device: NanoFUSE® Bioactive Matrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skeletally mature Medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix consistent with product labeling Psychosocially, mentally, and physically able to fully comply with the protocol, including the post-operative regimen, requires follow-up visits, filling out required forms, and the ability to understand and give written informed consent Retrospective data collection must be allowed by the IRB and all information deidentified Exclusion Criteria: Previous fusion surgery of the proposed site Use of chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day) Pregnant or female intending to become pregnant during this study period Obesity (BMI >40kg/m2) Systemic infection or infection at the surgical site Current or past substance abuse Poor general healthy or any concurrent disease process that would place the patient in excessive risk to surgery (e.g. significant circulatory or pulmonary problems, cardiac disease Medical condition that would interfere with post-operative assessments and care

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® PMCF<br>NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon. | Device: NanoFUSE® Bioactive Matrix<br>* NanoFUSE® is placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Success that indicates patient achieving fused or probably fused status. | 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 | 12 months postoperatively | 

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