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Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease

Primary Purpose

BKP, Osteoporotic Vertebral Compression Fracture, Kummell's Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SAIF
BKP
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BKP

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 60 or above, gender not specified. Must have one to three vertebral segments with vertebral compression fracture (VCF) located between T5 and L5, attributed to underlying primary or secondary osteoporosis rather than cancer. All VCFs must exhibit the following radiographic changes: according to Genant's criteria, acute (≤4 months) decrease in anterior, middle, or posterior vertebral height by at least one grade (20-25% reduction in vertebral height, 10-20% reduction in vertebral area) compared to previous X-ray, CT, or MRI results. All VCFs for treatment must occur within four months or less. All VCFs for treatment must be technically feasible and clinically suitable for BKP or SAIF surgery. Pre-treatment back pain NRS score must be ≥ 7 and ineffective with conservative (non-surgical) treatment. Pre-treatment Oswestry Disability Index must be ≥ 30 (on a scale of 0-100). Patient's life expectancy must be ≥ 12 months. Must declare willingness to participate in all post-operative follow-ups. Must be capable of understanding the risks and benefits of the study and willing to provide written informed consent. Exclusion Criteria: Vertebral morphology or fracture morphology unsuitable for balloon kyphoplasty. VCF caused by high-energy trauma. Asymptomatic VCF or vertebral bodies amenable to prophylactic treatment. VCF at the same site associated with primary bone tumors. Back pain caused by reasons other than acute fractures. VCF with an estimated fracture time of more than 4 months, based on clinical assessment (radiological evidence and patient history). VCF associated with secondary radiculopathy or neurological compromise. VCF requiring spinal surgery other than BKP or SAIF. Spinal cord compression or vertebral canal injury requiring decompression surgery. Combined clinical conditions unsuitable for surgery or affecting subsequent long-term data collection or follow-up. Allergy to any component during the surgical procedure (e.g., bone cement, contrast agents). Concurrent participation in another clinical study. Pregnancy during the study or planning to become pregnant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SAIF

    BKP

    Arm Description

    patients will be treated with kyphoplasty surgery combined with pedicular screw-assisted internal fixation for vertebral augmentation

    patients will be treated with balloon kyphoplasty surgery for vertebral augmentation

    Outcomes

    Primary Outcome Measures

    ODI score
    Each patients were asked to complete the Oswestry Disability Index questionnaire postoperatively during follow up

    Secondary Outcome Measures

    CT imaging indicators related to vertebral body stability
    There are total 5 indicators measured based on CT images: Anterior vertebral height (ant VBH), middle vertebral height (mid VBH), posterior vertebral height (post VBH), vertebral kyphosis angle (VKA), local kyphosis angle (LKA)
    SF36 score
    SF-36 questionnaire aimed at two different constructs to measure health-related quality of life: the Physical Component and the Mental Component
    VAS score
    The Visual Analogue Scale (VAS) measures pain intensity. 0 indicates no pain and 10 indicates pain as bad as it could possibly be
    EQ-5D score
    The EQ-5D descriptive system measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Full Information

    First Posted
    October 19, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06093087
    Brief Title
    Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease
    Official Title
    Internal Fixation Reconstruction With Stent Screw VS Balloon Kyphoplasty in the Treatment of Kummell's Disease: a Double Blinded Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 1, 2027 (Anticipated)
    Study Completion Date
    September 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (Kummell's disease) are better with the use of stent screw internal fixation and percutaneous bone cement reconstruction technique compared to patients undergoing traditional percutaneous balloon kyphoplasty (BKP) for vertebral augmentation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    BKP, Osteoporotic Vertebral Compression Fracture, Kummell's Disease, Stent-screw-assisted Internal Fixation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SAIF
    Arm Type
    Experimental
    Arm Description
    patients will be treated with kyphoplasty surgery combined with pedicular screw-assisted internal fixation for vertebral augmentation
    Arm Title
    BKP
    Arm Type
    Active Comparator
    Arm Description
    patients will be treated with balloon kyphoplasty surgery for vertebral augmentation
    Intervention Type
    Procedure
    Intervention Name(s)
    SAIF
    Intervention Description
    The patient was placed in a prone position under general anesthesia. Using a C-arm X-ray machine and a positioning plate for navigation, the target position on the vertebral body was located one the surface of the body. The puncture needle core was withdrawn after puncturing, and a guide needle was inserted. After removing the puncture needle sleeve, a hollow bone cement screw was screwed into the anterior column of the vertebral body through the guide needle. Subsequently, bone cement was injected into the appropriate position through the bone cement screw to restore the vertebral height
    Intervention Type
    Procedure
    Intervention Name(s)
    BKP
    Intervention Description
    The patient was placed in a prone position after general anesthesia. Using a C-arm X-ray machine and a positioning plate for guidance, the target position on the vertebral body was located from the surface of the body. A puncture needle sleeve was inserted into the vertebral body. A PKP balloon was then inserted to perform vertebral restoration. After removing the balloon, an appropriate amount of bone cement was injected to ensure even distribution within the vertebral body. Vertebral height augmentation and restoration will then be achieved.
    Primary Outcome Measure Information:
    Title
    ODI score
    Description
    Each patients were asked to complete the Oswestry Disability Index questionnaire postoperatively during follow up
    Time Frame
    ODI score measured 1,3,6 months post surgery during follow up
    Secondary Outcome Measure Information:
    Title
    CT imaging indicators related to vertebral body stability
    Description
    There are total 5 indicators measured based on CT images: Anterior vertebral height (ant VBH), middle vertebral height (mid VBH), posterior vertebral height (post VBH), vertebral kyphosis angle (VKA), local kyphosis angle (LKA)
    Time Frame
    all variables were measured 1,3,6 months post surgery during follow up
    Title
    SF36 score
    Description
    SF-36 questionnaire aimed at two different constructs to measure health-related quality of life: the Physical Component and the Mental Component
    Time Frame
    measured 1,3,6 months post surgery during follow up
    Title
    VAS score
    Description
    The Visual Analogue Scale (VAS) measures pain intensity. 0 indicates no pain and 10 indicates pain as bad as it could possibly be
    Time Frame
    measured 1,3,6 months post surgery during follow up
    Title
    EQ-5D score
    Description
    The EQ-5D descriptive system measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
    Time Frame
    measured 1,3,6 months post surgery during follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 60 or above, gender not specified. Must have one to three vertebral segments with vertebral compression fracture (VCF) located between T5 and L5, attributed to underlying primary or secondary osteoporosis rather than cancer. All VCFs must exhibit the following radiographic changes: according to Genant's criteria, acute (≤4 months) decrease in anterior, middle, or posterior vertebral height by at least one grade (20-25% reduction in vertebral height, 10-20% reduction in vertebral area) compared to previous X-ray, CT, or MRI results. All VCFs for treatment must occur within four months or less. All VCFs for treatment must be technically feasible and clinically suitable for BKP or SAIF surgery. Pre-treatment back pain NRS score must be ≥ 7 and ineffective with conservative (non-surgical) treatment. Pre-treatment Oswestry Disability Index must be ≥ 30 (on a scale of 0-100). Patient's life expectancy must be ≥ 12 months. Must declare willingness to participate in all post-operative follow-ups. Must be capable of understanding the risks and benefits of the study and willing to provide written informed consent. Exclusion Criteria: Vertebral morphology or fracture morphology unsuitable for balloon kyphoplasty. VCF caused by high-energy trauma. Asymptomatic VCF or vertebral bodies amenable to prophylactic treatment. VCF at the same site associated with primary bone tumors. Back pain caused by reasons other than acute fractures. VCF with an estimated fracture time of more than 4 months, based on clinical assessment (radiological evidence and patient history). VCF associated with secondary radiculopathy or neurological compromise. VCF requiring spinal surgery other than BKP or SAIF. Spinal cord compression or vertebral canal injury requiring decompression surgery. Combined clinical conditions unsuitable for surgery or affecting subsequent long-term data collection or follow-up. Allergy to any component during the surgical procedure (e.g., bone cement, contrast agents). Concurrent participation in another clinical study. Pregnancy during the study or planning to become pregnant.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wanli Li, MD
    Phone
    +86 13967116021
    Email
    liwanli@zju.edu.cn

    12. IPD Sharing Statement

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