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Study Confirms or Refutes the Hypothesis That the Autologous Bone Marrow Concentrate Together With the Allograft is a Better Alternative for the Posterolateral Fusion in Spine Surgery Than the Allograft Alone

Primary Purpose

Spondyloarthrosis, Spondylosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bone allogaft with bone marrow concentrate
Sponsored by
Hospital Znojmo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthrosis, Spondylosis focused on measuring Lumbar spine, Posterolateral fusion, Allograft, Bone marrow concentrate, Mesenchymal stem cells, Fusion rate

Eligibility Criteria

45 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • degenerative disc disease or degenerative spondylolisthesis

Exclusion Criteria:

  • vertebral fractures,
  • infections or spinal neoplasms,
  • non-rigid instrumentations,
  • medication affecting bone mineralization (e.g., corticosteroids),
  • body mass index higher than 35,
  • systemic diseases,
  • blood disease and/or immunosuppressant treatment and/or dicoumarol therapy;
  • immunosuppressant and/or neoplastic and/or infectious diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    bone marrow concentrate

    Arm Description

    In forty cases, the posterolateral fusion was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

    Outcomes

    Primary Outcome Measures

    The improvement of the fusion of the posterolateral fusion measured on X-rays
    Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
    The improvement of the fusion of the posterolateral fusion measured on X-rays and CT scans.
    Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2012
    Last Updated
    May 20, 2012
    Sponsor
    Hospital Znojmo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01603836
    Brief Title
    Study Confirms or Refutes the Hypothesis That the Autologous Bone Marrow Concentrate Together With the Allograft is a Better Alternative for the Posterolateral Fusion in Spine Surgery Than the Allograft Alone
    Official Title
    Allograft Alone Versus Allograft With Bone Marrow Concentrate for the Healing of the Instrumented Posterolateral Lumbar Fusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Znojmo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing. Allograft by itself is not an effective material as a posterior onlay graft for the PLF in adult surgery.
    Detailed Description
    The study was prospective, randomized, controlled and blinded. Eighty patients with degenerative disease of the lumbar spine underwent instrumented lumbar or lumbosacral PLF. In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spondyloarthrosis, Spondylosis
    Keywords
    Lumbar spine, Posterolateral fusion, Allograft, Bone marrow concentrate, Mesenchymal stem cells, Fusion rate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    bone marrow concentrate
    Arm Type
    Experimental
    Arm Description
    In forty cases, the posterolateral fusion was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
    Intervention Type
    Biological
    Intervention Name(s)
    bone allogaft with bone marrow concentrate
    Intervention Description
    In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
    Primary Outcome Measure Information:
    Title
    The improvement of the fusion of the posterolateral fusion measured on X-rays
    Description
    Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
    Time Frame
    12 months after the surgery
    Title
    The improvement of the fusion of the posterolateral fusion measured on X-rays and CT scans.
    Description
    Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
    Time Frame
    24months after the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: degenerative disc disease or degenerative spondylolisthesis Exclusion Criteria: vertebral fractures, infections or spinal neoplasms, non-rigid instrumentations, medication affecting bone mineralization (e.g., corticosteroids), body mass index higher than 35, systemic diseases, blood disease and/or immunosuppressant treatment and/or dicoumarol therapy; immunosuppressant and/or neoplastic and/or infectious diseases.

    12. IPD Sharing Statement

    Learn more about this trial

    Study Confirms or Refutes the Hypothesis That the Autologous Bone Marrow Concentrate Together With the Allograft is a Better Alternative for the Posterolateral Fusion in Spine Surgery Than the Allograft Alone

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