Clinical trial NCT07017634: Efficacy and Safety of NOVOSIS Putty for Interbody Lumbar Fusion Cases
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Degenerative Disc Disease
Lead sponsor: CGBio Inc.
Sponsor class: INDUSTRY
Collaborators: name: CGBio USA
First posted: 2025-06-12
Enrollment: 316
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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 preoperative Oswestry Disability Index score ≥ 40/100 at baseline
* 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.

Primary outcomes:
measure: Overall Success
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Overall Success
timeFrame: 6 and 12 months after surgery
measure: ODI score
timeFrame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
measure: VAS score
timeFrame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
measure: SF-12 score
timeFrame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
measure: Intraoperative variables
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
References: