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Degenerative Lumbar DiseasesNCT06715345

Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease

A study testing Bone graft materials and rhBMP-2 in people with Degenerative Lumbar Diseases, run by CGBio Inc. at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 80 years
Conditions the study is for
Degenerative Lumbar Diseases
What is being tested?
Bone graft materials and rhBMP-2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSouth Korea
Study dates
6 Mar 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • Subjects who have a pseudoarthrosis after previous fusion
  • Subjects who had a history of at least one non fusion spinal surgery on the level to be operated
  • Subjects who are considered to have a disease that hinders the accurate evaluation (e.g., neuromuscular disease, serious psychiatric disease) at the discretion of the investigator
  • Subjects who are pregnant at screening or who are planning to become pregnant during the study participation period
  • Subjects who are currently lactating or who are planning to lactate during the study
  • Subjects who participated in studies for other drugs, biologics, or medical devices within 6 months from the date of surgery
  • Subjects who are in a difficult situation to comply with study related matters

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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

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.

Read the 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
Being tested
Bone graft materials and rhBMP-2
Keywords
TLIF, Degenerative lumbar diseases, BMP-2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone graft materials and rhBMP-2Device

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

Study groups in NCT06715345
Study groupRoleWhat they receive
Control GroupNo interventionLocal autologous bone
Experimental Group 1ExperimentalDose 1
Receives: Device: Bone graft materials and rhBMP-2
Experimental Group 2ExperimentalDose 2
Receives: Device: Bone graft materials and rhBMP-2
Experimental Group 3ExperimentalDose 3
Receives: Device: Bone graft materials and rhBMP-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall bone fusion rate

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

    Measured: 12 months after surgery

  2. 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

    Measured: 12 months after surgery

Secondary outcomes (7)

  1. 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

    Measured: 6 and 24 months after surgery

  2. Bone fusion rate

    Bone fusion rate based on CT, X-ray

    Measured: 6, 12, and 24 months after surgery

  3. Oswestry Disability Index(ODI)

    Evaluate Oswestry Disability Index(ODI) score/ lowest 0(best) to highest 50(worst)

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

  4. SF-12 scores (general condition test)

    Evaluate SF-12 scores / lowest 0(worst) to highest 100(best)

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

  5. Numerical Rating Scale (NRS)

    Evaluate Numerical Rating Scale (NRS) scores / lowest 0(best) to highest 30(worst)

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

  6. Neurological Symptoms

    Evaluate Neurological Symptoms test/ check among the 3 questions(Worsened/ Constent/Improved) best is imporved, worst is worsened

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

  7. Satisfaction rate

    Evaluate Satisfaction rate score / lowest 0(worst) to highest 3(best)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start6 Mar 2024
  3. Primary completion30 Jun 2024
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
single blind( subject - blind, investigator -open, Outcome assessor- blind)
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06715345
Sponsor's protocol ID
B2201
Status last verified
Nov 2024
First submitted
26 Nov 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bone graft materials and rhBMP-2 in people with Degenerative Lumbar Diseases, run by CGBio Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall bone fusion rate (time frame: 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06715345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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