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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
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring rhBMP-2, lumbar fusion, fusion rate, osteoporosis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 5, 2023
    Last Updated
    June 20, 2023
    Sponsor
    Xijing Hospital
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    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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