Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease

NCT06715345 | Active Not Recruiting

• 1 other identifier: B2201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Lumbar Diseases

Keywords

TLIF; Degenerative lumbar diseases; BMP-2

Outcome Measures

Primary Outcomes (2)

• Overall bone fusion rate

  Meet the definition of bone fusion based on CT and the definition of bone fusion based on X-ray simultaneously.

  12 months after surgery

• Overall fusion success rate

  Meet all of the following conditions: 1. Success in ODI 2. Overall Bone Fusion Success 3. Neurological Success 4. No serious adverse event 5. No re-operation

  12 months after surgery

Secondary Outcomes (7)

• Overall fusion success rate

  6 and 24 months after surgery

• Bone fusion rate

  6, 12, and 24 months after surgery

• Oswestry Disability Index(ODI)

  6 weeks, 3, 6, 12, and 24 months after surgery

• SF-12 scores (general condition test)

  6 weeks, 3, 6, 12, and 24 months after surgery

• Numerical Rating Scale (NRS)

  6 weeks, 3, 6, 12, and 24 months after surgery

Study Arms (4)

Control Group

NO INTERVENTION

Local autologous bone

Experimental Group 1

EXPERIMENTAL

Dose 1

Device: Bone graft materials and rhBMP-2

Experimental Group 2

EXPERIMENTAL

Dose 2

Device: Bone graft materials and rhBMP-2

Experimental Group 3

EXPERIMENTAL

Dose 3

Device: Bone graft materials and rhBMP-2

Interventions

Bone graft materials and rhBMP-2 DEVICE

NOVOSIS PUTTY is a product composed of recombinant human bone morphogenetic protein-2 and β-tricalcium phosphate/hydrogel complex.

Experimental Group 1; Experimental Group 2; Experimental Group 3

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• Subjects who need to administer drugs that inhibit bone metabolism within 2 weeks after surgery, or Subjects who need to receive post operative drugs that are expected to interfere with bone fusion, such as steroids
• Subjects who smoke ≥ 20 cigarettes a day
• Subjects with autoimmune disease
• Subjects who were exposed to rhBMP 2 in the past
• Subjects who require to get fusion of two or more vertebral levels

Sponsors & Collaborators

• CGBio Inc.: lead

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Jumi Han

  CGBio Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: single blind( subject - blind, investigator -open, Outcome assessor- blind)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single blind( subject - blind, investigator -open, Outcome assessor- blind)

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: March 6, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)