Efficacy and Safety of NOVOSIS Putty for Interbody Lumbar Fusion Cases

Launched by CGBIO INC. · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a special material called NOVOSIS Putty for treating a condition known as degenerative disc disease in the lower back. The trial will involve patients who are experiencing significant back pain due to wear and tear on their spinal discs. To be eligible for the study, participants should be between the ages of 18 and 80, have a specific level of back pain as measured by a score on a disability questionnaire, and be able to follow the study’s requirements, including attending follow-up appointments.

Participants in this trial will undergo a procedure called transforaminal lumbar interbody fusion, which is a type of spinal surgery aimed at relieving pain and stabilizing the spine. It's important to note that people with certain medical conditions, previous spinal surgeries, or who are pregnant cannot participate. The trial is still in the planning stages and has not started recruiting participants yet, but those who join can expect to receive close monitoring and care throughout the study to evaluate how well the NOVOSIS Putty works for their condition.

Gender

ALL

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.