OssiMend BA in Posterolateral Instrumented Lumbar Fusion

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material

Detailed Description
-----------------
The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to OssiMend Bioactive Moldable. The secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).

Official Title
-----------------
OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion

Conditions
-----------------
Spinal Disease, Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: OssiMend™ Bioactive Moldable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings: Instability as defined by >3mm translation or >5 degrees angulation Osteophyte formation of facet joints or vertebral endplates Decreased disc height, on average by >2mm, but dependent upon the spinal level Herniated nucleus pulposus Facet joint degeneration/changes Exclusion Criteria: Subject is under 18 years of age at the time of consent Subject has had prior lumbar spine fusion surgery at any level Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis Subject has an active (local or systemic) infection or is undergoing adjunctive treatment for infection Subjects under workers compensation or active litigation

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OssiMend™ Bioactive Moldable<br>Patients undergoing Lumber Spine Fusion | Device: OssiMend™ Bioactive Moldable<br>* Lumbar Spine fusion with OssiMend™ Bioactive Moldable<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Success | Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) of back and leg (left and right) | Improvement of pain as defined by the Visual analog scale (VAS) of back and leg (left and right) | 12 months | 
| Oswestry Lower Back Pain Questionnaire | Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire | 12 months | 
| SF36 | Pain and function as measured by the Short - Form 36 | 12 months | 

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