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Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease | Clinical Trials | Clareo Health

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Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease

Sponsor-initiated Clinical Study to Evaluate the Efficacy and Safety of Novosis Putty for Bone Fusion in Patients Requiring Posterior Instrumentation and Transforaminal Lumbar Interbody Fusion Due to Degenerative Lumbar Disease

NCT06715345•CGBio Inc.

View on ClinicalTrials.gov

Summary

This clinical study aims to evaluate the efficacy and safety of NOVOSIS PUTTY for bone fusion in patients requiring posterior instrumentation and transforaminal lumbar interbody fusion (TLIF) due to degenerative lumbar disease.

Detailed Description

The Subject is a patient requiring posterior instrumentation and transforaminal lumbar interbody fusion (TLIF) due to degenerative lumbar disease. This clinical study aims to compare and evaluate the efficacy and safety of three dose groups of NOVOSIS PUTTY for bone fusion compared to the autologous bone in patients requiring posterior instrumentation and TLIF in the single level between L2 and S1(L2-S1) due to degenerative lumbar disease. * Control Group (n=12): Local autologous bone * Experimental Group 1 (n=12): Dose 1 * Experimental Group 2 (n=12): Dose 2 * Experimental Group 3 (n=12): Dose 3

Eligibility

Age

22 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult aged ≥ 22 to ≤ 80 years
•Subjects whose skeletal maturation are confirmed by showing the result of Risser stage 5 in Risser classification, the Plain Radiography
•Subjects diagnosed with disc degeneration in the single level (L2-S1) lumbar spine along with spondylolisthesis of Meyerding grade 1 (degree of translocation: 0- \<25%) or 2 (degree of translocation: 25- \<50%) based on the results of radiological examination (CT, MRI, X-ray).
•Subjects with an ODI (Oswestry Disability Index) score of ≥ 35/100 at screening
•Subjects who were treated with non surgical treatment/therapy for at least 3 months, but were judged to have failed treatment by the investigator
•Subjects who are willing to participate in the study, comply with treatment and procedures, and visit the hospital for all observational evaluations
•Subjects who voluntarily signed the informed consent form after hearing the explanation on objectives and methods of this study

Exclusion Criteria

•Subjects who have a history of medical device application (spinal instrumentation, for example, anterior disc replacement, interspinous device) to the target site or interbody fusion
•Subjects who are considered that the symptoms occurring in the lumbar region are not occurred by disc degeneration
•Subjects with active malignancy
•Subjects with a documented history of drug abuse (e.g., psychotropic drugs including narcotic analgesics and drugs with high dependence such as alcohol) within the last 6 months
•Subjects with a history of endocrine or metabolic disorders known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehler Danlos disease, or osteogenesis imperfecta)
•Subjects with BMI ≥ 35
•Subjects with spondylolis thesis/retrolisthesis with ≥ Grade 3 in the target level
•Subjects with a local acute infection at the current surgical site or active systemic infection (e.g., viral infections such as AIDS, HIV or hepatitis)
•Subjects with a history of metabolic or endocrine diseases known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers Danlos disease, osteogenesis imperfecta, fibrous dysplasia, etc.)
•Subjects with osteoporosis with a mean lumbar spine T-score of ≤ 2.5 on the DEXA bone density test and with a history of osteoporotic fractures (wrist fractures, femur fractures, lumbar spine fractures, etc.)
+12 more criteria

Locations (1)

Severance hospital

Seoul, South Korea

Key Dates

Start Date

March 6, 2024

Primary Completion Date

June 30, 2024

Completion Date

December 31, 2025

Last Updated

December 4, 2024

Enrollment

ACTUAL participants

Conditions

Degenerative Lumbar Diseases

Interventions

Bone graft materials and rhBMP-2

DEVICE

Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®

NCT06876311

Degenerative Cervical Disc DiseaseDegenerative Lumbar Diseases

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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