Recruiting NCT07017634
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novosis Putty, Standard of Care.
- Who it may be relevant to
- Registry conditions: Degenerative Disc Disease. Basic parameters: 21 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Device Novosis Putty
Single Level TLIF surgery with Novosis Putty - Other Standard of Care
Single Level TLIF surgery with standard of care bone graft
Primary outcome measures
- Overall Success [Time frame: 24 months after surgery]
Secondary outcome measures (10)
- Fusion Success [Time frame: 12 months after surgery]
- Overall Success [Time frame: 6 and 12 months after surgery]
- Fusion Success [Time frame: 6 and 24 months after surgery]
- ODI score [Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]
- VAS score [Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]
- SF-12 score [Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]
- Time to Fusion Success [Time frame: From surgery to 60 months after surgery]
- Time to First SSI [Time frame: From surgery to 60 months after surgery]
- Treatment satisfaction [Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]
- Intraoperative variables [Time frame: intraoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- The Spine Center of Louisiana — Baton Rouge
- LSU Health — Shreveport
- Thomas Jefferson University - Department of Neurological Surgery — Philadelphia
- American Neurospine Institute, PLLC — Frisco
- West Virginia University - Department of Orthopaedics — Morgantown
Identifiers
NCT: NCT07017634 · CGNVP002