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CompletedNCT06715345Updated Nov 9, 2026

Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease

An interventional study of Bone graft materials and rhBMP-2 in Degenerative Lumbar Diseases, sponsored by CGBio Inc.. Completed at 4 sites in South Korea. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by CGBio Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2024, registered Nov 2024).
Updated Nov 9, 2026Now CompletedPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
22 Years to 80 Years
Sex
All
01

Study 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 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 (BMP2_1mg)
  • Experimental Group 2 (n=12): Dose 2 (BMP2_2mg)
  • Experimental Group 3 (n=12): Dose 3 (BMP2_3mg)
02

Conditions studied

  • Degenerative Lumbar Diseases

Keywords

  • TLIF
  • Degenerative lumbar diseases
  • BMP-2
03

In context

Lead sponsor

CGBio Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form after hearing the explanation on objectives and methods of this study

Exclusion criteria

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
  • 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 ≥ 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, 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
  • Subjects who smoke ≥ 20 cigarettes a day
  • Subjects with 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • No intervention
    Control Group

    Local autologous bone

  • Experimental
    Experimental Group 1

    Dose 1(BMP2\_1mg)

    Device: Bone graft materials and rhBMP-2

  • Experimental
    Experimental Group 2

    Dose 2(BMP2\_2mg)

    Device: Bone graft materials and rhBMP-2

  • Experimental
    Experimental Group 3

    Dose 3(BMP2\_3mg)

    Device: Bone graft materials and rhBMP-2

Interventions

  • DeviceBone graft materials and rhBMP-2

    NOVOSIS PUTTY is a product composed of recombinant human bone morphogenetic protein-2(BMP2) and β-tricalcium phosphate/hydrogel complex.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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

    Time frame: 12 months after surgery

Secondary outcomes

  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

    Time frame: 6 and 24 months after surgery

  2. Bone fusion rate

    Bone fusion rate based on CT, X-ray

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 6 weeks, 3, 6, 12, and 24 months after surgery

  7. Satisfaction rate

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

    Time frame: 6 weeks, 3, 6, 12, and 24 months after surgery

07

Study locations

4 sites
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Seoul, 03312, South Korea
  • Asan medical center
    Seoul, 05505, South Korea
  • The Catholic University of Korea, Seoul ST. Mary's Hospital
    Seoul, 06591, South Korea
  • Severance hospital
    Seoul, South Korea
08

References and documents

Publications

  • Mobbs RJ, Phan K, Malham G, Seex K, Rao PJ. Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF. J Spine Surg. 2015 Dec;1(1):2-18. doi: 10.3978/j.issn.2414-469X.2015.10.05. PubMed 27683674 ↗
  • GJESSING MH. Osteoplastic anterior fusion of the lower lumbar spine in spondylolisthesis, localized spondylosis, and tuberculous spondylitis. Acta Orthop Scand. 1951;20(3):200-13. doi: 10.3109/17453675108991168. No abstract available. PubMed 14894192 ↗
  • Smith JS, Fu KM, Polly DW Jr, Sansur CA, Berven SH, Broadstone PA, Choma TJ, Goytan MJ, Noordeen HH, Knapp DR Jr, Hart RA, Donaldson WF 3rd, Perra JH, Boachie-Adjei O, Shaffrey CI. Complication rates of three common spine procedures and rates of thromboembolism following spine surgery based on 108,419 procedures: a report from the Scoliosis Research Society Morbidity and Mortality Committee. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2140-9. doi: 10.1097/BRS.0b013e3181cbc8e7. PubMed 20581760 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Mar 2024 to primary completion in Jul 2025, 16 months.

Primary completion moved once since we started tracking on Sep 25, 2026: Jun 2024 → Jul 2025, on Nov 9, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2024
First posted
Dec 4, 2024
StartActual
Mar 6, 2024
Primary completionActual
Jul 8, 2025was Jun 2024
CompletionActual
Dec 31, 2025
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Nov 9, 2026
Sites
3 sites added
Show 3 added (3 South Korea)
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital · Seoul, South Korea
  • Asan medical center · Seoul, South Korea
  • The Catholic University of Korea, Seoul ST. Mary's Hospital · Seoul, South Korea
Nov 9, 2026
Primary completion
Jun 30, 2024→Jul 8, 2025
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Active, not recruiting→Completed
    3 sites added
    Show 3 added (3 South Korea)
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital · Seoul, South Korea
    • Asan medical center · Seoul, South Korea
    • The Catholic University of Korea, Seoul ST. Mary's Hospital · Seoul, South Korea
    Primary completion Jun 30, 2024→Jul 8, 2025
    + 4 other changes: verification date, description, arm descriptions and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06715345
Lead sponsor
CGBio Inc.
Responsible party
Sponsor
First posted
Dec 4, 2024
Start date
Mar 6, 2024
Primary completion
Jul 8, 2025
Completion
Dec 31, 2025
Last update
Nov 9, 2026

Study contacts

Jumi Han
study chair · CGBio Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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