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Evaluation of the efficacy and safety of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion to treat Degenerative Spinal Disease: A prospective, randomized, Assessor blind, multicenter trial

Status Approved

First Submitted Date

2020/11/05
Registered Date

2020/11/19
Last Updated Date

2022/01/04

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005610
Unique Protocol ID	B-2008/630-003
Public/Brief Title	Evaluation of the efficacy and safety of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion
Scientific Title	Evaluation of the efficacy and safety of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion to treat Degenerative Spinal Disease: A prospective, randomized, Assessor blind, multicenter trial
Acronym	Transforaminal interbody fusion with rhBMP (TiBone)
MFDS Regulated Study	Yes
IND/IDE Protocol	Yes
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted approval

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	B-2008/630-003
Approval Date	2020-11-03
Institutional Review Board Name	Seoul National University Bundang Hospital Institutional Review Board
Institutional Review Board Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-787-8801
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Sang-Min Park
Title	Professor
Telephone	+82-31-787-7208
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea
Contact Person for Public Queries
Name	Sang-Min Park
Title	Professor
Telephone	+82-31-787-7208
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea
Contact Person for Updating Information
Name	Sang-Min Park
Title	Professor
Telephone	+82-31-787-7208
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 6
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2022-01-10 Anticipated
Target Number of Participant	154
Primary Completion Date	2025-07-07 , Anticipated
Study Completion Date	2025-07-07 , Anticipated
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2022-01-17 ,
Recruitment Status by Participating Study Site 2
Name of Study	Chung-Ang Univerisity Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2022-01-10 ,
Recruitment Status by Participating Study Site 3
Name of Study	Hanyang University Seoul Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2022-03-01 ,
Recruitment Status by Participating Study Site 4
Name of Study	Hallym University Medical Center-Kangnam
Recruitment Status	Not yet recruiting
Date of First Enrollment	2022-03-01 ,
Recruitment Status by Participating Study Site 5
Name of Study	Yonsei University Health System, Gangnam Severance Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2022-03-01 ,
Recruitment Status by Participating Study Site 6
Name of Study	Korea University Ansan Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2022-03-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	CGBio
Organization Type	Others
Project ID	B2001

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute
2. Sponsor Organization
Organization Name	Chung-Ang Univerisity Hospital
Organization Type	Medical Institute
3. Sponsor Organization
Organization Name	Hanyang University Seoul Hospital
Organization Type	Medical Institute
4. Sponsor Organization
Organization Name	Hallym University Medical Center-Kangnam
Organization Type	Medical Institute
5. Sponsor Organization
Organization Name	Yonsei University Health System, Gangnam Severance Hospital
Organization Type	Medical Institute
6. Sponsor Organization
Organization Name	Korea University Ansan Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this study is to evaluate the fusion rate and safety at 1 year of patients who undergo a Transforaminal Lumbar Interbody Fusion(TLIF) with Novosis or autologous iliac bone.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	Before the start of this clinical trial, all researchers participating in the trial agree on the method of treatment for the clinical trial medical device and perform the procedure in a standardized manner. The applicable dose of the Escherichia coli-derived recombinant human bone morphogenetic protein-2(rhBMP-2) used in this clinical trial is a maximum of 0.5 mg~1.0mg per level and the applicable dose per person is rhBMP-2 up to 2.0 mg in total.
Number of Arms	2
Arm 1	Arm Label Transforaminal lumbar interbody fusion(TLIF) using synthetic bone graft substitutes with growth factors
	Target Number of Participant 77
	Arm Type Experimental
	Arm Description Transforaminal Lumbar Interbody Fusion(TLIF) with Novosis. The applicable dose of the Escherichia coli-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) used in this clinical trial is a maximum of 0.5 mg~1.0mg per level and the applicable dose per person is rhBMP-2 up to 2.0 mg in total.
Arm 2	Arm Label Transforaminal lumbar interbody fusion(TLIF) using autologous iliac bone.
	Target Number of Participant 77
	Arm Type Active comparator
	Arm Description Transforaminal Lumbar Interbody Fusion(TLIF) with autologous iliac bone.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M48.06)Spinal stenosis, lumbar region Patients requiring one- or two-level laminectomy with fusion (TLIF) for spinal stenosis, severe herniated disc, spondylolysis or spondylolisthesis, recurrent disc herniation
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~80Year
	Description 1. 19~75 years of age at the date of written informed consent 2. Patients requiring one- or two-level laminectomy with fusion for the following reasons (This clinical trial is performed for patients who do not respond despite 3 months of conservative treatment or who continue to have pain with a VAS score of 4 or higher.) 1) Spinal Stenosis 2) Severe herniated disc with neurologic deficit (such as cauda equina syndrome) 3) Spondylolysis or spondylolisthesis 4) Recurrent Lumbar Disc Herniation etc. 3. It able to comply with the study plan and can visit every follow-up for this study 4. It able to understand and sign the subject Informed Consent Form.
Exclusion Criteria	1. Prior interbody surgery at the same level 2. Pregnant or lactating women, or those who are planning pregnancy for the duration of this clinical trial or don't agree to medically accepted contraceptive methods * Medically accepted contraceptive methods: condoms, oral contraceptives for at least 3 months, injectable or implantable contraceptives, and intrauterine contraceptives, etc. 3. Severe osteoporosis on DEXA bone density test (DEXA T-score is -3.0 or lower) 4. Active malignancy or having been on chemotherapy of any kind for a malignancy in the past 5 year 5. Hypersensitivity to rhBMP-2, Hydroxyapatite,PEEK. 6. Those who are diagnosed with the following disease. 1) Mental illness 2) Drug intoxication and alcoholism 3) liver disease; Liver cancer, cirrhosis, acute/chronic hepatitis4) Acute/chronic renal failure 4) kidney disease; Acute/chronic renal failure, Elimination disorders 5) heart disease; Severe heart failure 6) respiratory diseases; Active tuberculosis 7) infectious diseases; Active systemic infection and application site infection 8) metabolic diseases; Rickets, osteomalacia, pituitary dysfunction, thyroid dysfunction, and other bone metabolic disorders 9) fracture of the applied area; osteoporotic vertebral fracture, spine trauma fracture 7. Those who can’t prohibit drugs (parathyroid hormone, bisphosphonate, Systemic Steroid) that may affect bone metabolism during the prohibition period 8. Those who severe autoimmune disease 9. Those who smoke more than 20 per day 10. BMI > 35 kg/m2 11. Those who can’t stop taking antithrombotic or anticoagulant before surgery 12. Uncontrolled diabetes or hypertension or blood coagulation defect 13. terminal patient 14. Those who cannot understand the purpose and method of clinical trials 15. Patients who have participated in other medical device clinical trials within six months (For clinical trials of drugs, within 30 days) 16. Others, if judged by the investigator to be inappropriate for participation in this clinical trial
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Bone fusion rate on CT after surgery (%)
Timepoint	52 weeks after surgery
Secondary Outcome(s) 1
Outcome	Bone fusion rate on CT after surgery (%) : evaluation by surgical site(level)
Timepoint	52 weeks after surgery
Secondary Outcome(s) 2
Outcome	Serial ODI score changes after surgery
Timepoint	at before surgery, 12, 24, and 52 weeks after surgery
Secondary Outcome(s) 3
Outcome	Serial EQ-5D score changes
Timepoint	at before surgery, 12, 24, and 52 weeks after surgery
Secondary Outcome(s) 4
Outcome	Serial VAS score changes
Timepoint	at before surgery, 12, 24, and 52 weeks after surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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