Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion
Primary Purpose
Osteoporosis, Spinal Fusion
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RhBMP-2
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring rhBMP-2, lumbar fusion, fusion rate, osteoporosis
Eligibility Criteria
Inclusion Criteria: patients diagnosed with degenerative lumbar diseases. patients underwent one-level TLIF osteoporosis (DXA T≤-2.5) complete preoperative and follow-up data (imaging and health-related quality of life) Exclusion Criteria: history of previous spinal surgery inflammatory and neoplastic diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
rhBMP-2 group
No rhBMP-2 group
Arm Description
Outcomes
Primary Outcome Measures
Fusion rate at 6 months
<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs
Bridging bone connecting the adjacent vertebral bodies either through the implants or around the implants, and an absence of radiolucent lines around >50% of either implant from computed tomography (CT) scans of lumbar
Fusion rate at 3 months
<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs of radiolucent lines around >50% of either implant
Secondary Outcome Measures
Visual Analog Score for low back pain (VAS-B)
range from 0-10, a higher score means a worse outcome.Short Form Survey (SF-36)
Visual Analog Score for leg pain (VAS-L)
range from 0-10, a higher score means a worse outcome.
Oswestry disability index (ODI)
range from 0-100%, a higher score means a worse outcome.
36-Item Short Form Survey (SF-36)
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36) in 1992. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Incidence of complications
infection, revision surgery, etc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05911477
Brief Title
Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion
Official Title
Effect of rhBMP-2 on Early Bone Formation in Patients With Osteoporosis After Lumbar Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
rhBMP-2 has been used to promote spinal fusion. Despite potential risk of complications, satisfied results could be obtained with low dose of rhBMP-2. Effect of early bone formation has been validated using rat ovariectomy osteoporosis model. However, whether it functioned in patients with osteoporosis remained unknown. In this study, the investigators intend to investigate whether rhBMP-2 promotes early bone formation in patients with osteoporosis after transforaminal lumbar interbody fusion (TLIF).
Detailed Description
Pseudoarthrosis and many complications associated with iliac crest bone graft (ICBG) has prompted the spine surgeons to seek alternative methods to promote rate of spinal fusion. The rhBMP-2 received FDA approval in 2002 for use as an alternative to autograft for single-level anterior lumbar interbody fusion (ALIF). Many studies reported equivalent or better fusion rates. Recent studies, however, identified complications related to rhBMP-2 use such as osteolysis, graft subsidence, and retrograde ejaculation and other urological complications. Overdose of rhBMP-2 in patients may lead to complications mentioned above. A recent randomized controlled trial in 2022 confirmed a low dose usage of rhBMP-2 promoted fusion after TLIF (21.mg per fusion level) without increase in complications.
Current fusion methods achieve interbody fusion by filling the cage in the central region of the intervertebral space with bone graft material. However, the early fusion rates (at 3 and 6 months postoperatively) are often unsatisfactory. According to present literatures, the 3-month and 6-month fusion rates have ranged from 2.9% to 43.1% and 30% to 68.8%, respectively. Although a lack of fusion may be asymptomatic, it may potentially lead to complications, even a reoperation. In addition, failure to achieve early fusion may result in a delayed return to work, and reduced patient satisfaction, especially in patients with osteoporosis. Whether rhBMP-2 may lead to higher and early fusion rate in osteoporosis patient remains unknown.
In this study, the investigators intend to compare the time it takes to achieve osseous union/fusion and the clinical efficacy of using rhBMP-2 to control group in TLIF. The rhBMP-2 in the study is produced by a domestic enterprise (HANGZHOU JIUYUAN GENE ENGINEERING CO .,LTD., Hangzhou, China).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Spinal Fusion
Keywords
rhBMP-2, lumbar fusion, fusion rate, osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rhBMP-2 group
Arm Type
Experimental
Arm Title
No rhBMP-2 group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
RhBMP-2
Intervention Description
1mg RhBMP-2 for one fusion-level
Primary Outcome Measure Information:
Title
Fusion rate at 6 months
Description
<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs
Bridging bone connecting the adjacent vertebral bodies either through the implants or around the implants, and an absence of radiolucent lines around >50% of either implant from computed tomography (CT) scans of lumbar
Time Frame
6 months follow-up
Title
Fusion rate at 3 months
Description
<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs of radiolucent lines around >50% of either implant
Time Frame
3 months follow-up
Secondary Outcome Measure Information:
Title
Visual Analog Score for low back pain (VAS-B)
Description
range from 0-10, a higher score means a worse outcome.Short Form Survey (SF-36)
Time Frame
pre- and post-operative immediately, 3- and 6- months follow-up
Title
Visual Analog Score for leg pain (VAS-L)
Description
range from 0-10, a higher score means a worse outcome.
Time Frame
pre- and post-operative immediately, 3- and 6- months follow-up
Title
Oswestry disability index (ODI)
Description
range from 0-100%, a higher score means a worse outcome.
Time Frame
pre-operatively, 3- and 6-months follow-up
Title
36-Item Short Form Survey (SF-36)
Description
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36) in 1992. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Time Frame
pre-operatively, 3- and 6-months follow-up
Title
Incidence of complications
Description
infection, revision surgery, etc.
Time Frame
post-operative immediately, 3- and 6- months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed with degenerative lumbar diseases.
patients underwent one-level TLIF
osteoporosis (DXA T≤-2.5)
complete preoperative and follow-up data (imaging and health-related quality of life)
Exclusion Criteria:
history of previous spinal surgery
inflammatory and neoplastic diseases
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Other researchers should ask for permissions from the investigator.
IPD Sharing Time Frame
one year after the study is finished.
IPD Sharing Access Criteria
Through emails after Obtaining written permission from the investigator
Learn more about this trial
Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion
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