Degenerative Disc Disease
Conditions
Brief summary
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study
Interventions
DEVICENovosis Putty
Single Level TLIF surgery with Novosis Putty
OTHERStandard of Care
Single Level TLIF surgery with standard of care bone graft
Sponsors
CGBio Inc.
CGBio USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTJumi Han
Outcome results
None listed