Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease

• Novosis Putty (Device): Single Level TLIF surgery with Novosis Putty
• Standard of Care (Other): Single Level TLIF surgery with standard of care bone graft

Primary outcomes

• Overall Success [24 months after surgery]: Meet all of the following conditions: 1. Fusion success 2. Oswestry Disability Index success 3. Neurological success 4. No subsequent surgical interventions 5. No related serious event

Secondary outcomes

• Fusion Success [12 months after surgery]: Fusion Success at Month 12 via CT scan and X-ray defined by the success of the 3 components: Interbody Bridging Bone from the superior to the inferior vertebral body (via CT), Angular Motion ≤ 5° (via X-ray) AND Translational Motion ≤ 3 mm at the index level (via X-ray). Secondary categorical endpoints will be summarized over time using counts and percentages.
• Overall Success [6 and 12 months after surgery]: Meet all of the following conditions: 1. Fusion success 2. Oswestry Disability Index success 3. Neurological success 4. No subsequent surgical interventions 5. No related serious event
• Fusion Success [6 and 24 months after surgery]: Fusion Success at Month 6 and Month 24 via CT scan and X-ray defined by the success of the 3 components: Interbody Bridging Bone from the superior to the inferior vertebral body (via CT), Angular Motion ≤ 5° (via X-ray) AND Translational Motion ≤ 3 mm at the index level (via X-ray). Secondary categorical endpoints will be summarized over time using counts and percentages.
• ODI score [6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]: Evaluate Oswestry Disability Index(ODI) score/ lowest 0(best) to highest 100(worst)
• VAS score [6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]: Evaluate Visual Analog Scale(VAS) score/ none (0 mm) to an extreme amount of pain (100mm)
• SF-12 score [6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]: Evaluate SF-12 scores / lowest 0(worst) to highest 100(best)
• Time to Fusion Success [From surgery to 60 months after surgery]
• Time to First SSI [From surgery to 60 months after surgery]
• Treatment satisfaction [6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]
• Intraoperative variables [intraoperative]: Surgery time, blood loss

Sex: All, ages: 21 Years to 80 Years

Inclusion Criteria:

* Has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 2 (≤50% translation) spondylolisthesis. Symptomatic lumbar degeneration (L1 to S1) that may be associated with a co-morbid condition.
* Has a history of failure conservative treatment (e.g. bed rest, physical therapy, medications, transcutaneous electrical nerve stimulation (TENS), manipulation, and/or spinal injections) for at least 6 months
* Has preoperative Oswestry Disability Index score ≥ 40/100 at baseline
* Male or Female, 21-80 years of age and skeletally mature at the time of surgery
* Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
* Signed informed consent

Exclusion Criteria:

* Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
* Degenerative or lytic spondylolisthesis greater than Grade 2 (50% translation);
* Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
* Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis;
* Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;
* Lactating, pregnant or interested in becoming pregnant in the next 3 years;
* Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.
* Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.