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Trial record 4 of 1834 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03793530
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Aeon Biotechnology Corporation
Information provided by (Responsible Party):
Pei-Yuan Lee, MD, Show Chwan Memorial Hospital

Tracking Information
First Submitted Date  ICMJE January 2, 2019
First Posted Date  ICMJE January 4, 2019
Last Update Posted Date January 7, 2019
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
3-month postoperative spinal function evaluated by Oswestry Disability Index [ Time Frame: 3-month postoperative ]
Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
3-month postoperative spinal function evaluated by Oswestry Disability Index [ Time Frame: 3-month postoperative ]
Subjective evaluation of spinal function by Oswestry Disability Index.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
  • 6-month postoperative spinal function evaluated by Oswestry Disability Index [ Time Frame: 6-month postoperative ]
    Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
  • 12-month postoperative spinal function evaluated by Oswestry Disability Index [ Time Frame: 12-month postoperative ]
    Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.
  • 3-month postoperative degree of pain evaluated by visual analogue scale [ Time Frame: 3-month postoperative ]
    Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.
  • 6-month postoperative degree of pain evaluated by visual analogue scale [ Time Frame: 6-month postoperative ]
    Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.
  • 12-month postoperative degree of pain evaluated by visual analogue scale [ Time Frame: 12-month postoperative ]
    Subjective evaluation of degree of pain by visual analogue scale. Visual analogue scale for pain ranges from 0 to 10 and higher score indicates more pain.
  • 3-month postoperative degree of bone healing evaluated by plain radiograph [ Time Frame: 3-month postoperative ]
    Degree of bone healing evaluated by plain radiograph
  • 6-month postoperative degree of bone healing evaluated by plain radiograph [ Time Frame: 6-month postoperative ]
    Degree of bone healing evaluated by plain radiograph
  • 12-month postoperative degree of bone healing evaluated by plain radiograph [ Time Frame: 12-month postoperative ]
    Degree of bone healing evaluated by plain radiograph
  • 12-month postoperative degree of bone healing evaluated by computed tomograph [ Time Frame: 12-month postoperative ]
    Degree of bone healing evaluated by computed tomograph
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
  • 6-month postoperative spinal function evaluated by Oswestry Disability Index [ Time Frame: 6-month postoperative ]
    Subjective evaluation of spinal function by Oswestry Disability Index.
  • 12-month postoperative spinal function evaluated by Oswestry Disability Index [ Time Frame: 12-month postoperative ]
    Subjective evaluation of spinal function by Oswestry Disability Index.
  • 3-month postoperative degree of pain evaluated by visual analogue scale [ Time Frame: 3-month postoperative ]
    Subjective evaluation of degree of pain by visual analogue scale
  • 6-month postoperative degree of pain evaluated by visual analogue scale [ Time Frame: 6-month postoperative ]
    Subjective evaluation of degree of pain by visual analogue scale
  • 12-month postoperative degree of pain evaluated by visual analogue scale [ Time Frame: 12-month postoperative ]
    Subjective evaluation of degree of pain by visual analogue scale
  • 3-month postoperative degree of bone healing evaluated by plain radiograph [ Time Frame: 3-month postoperative ]
    Degree of bone healing evaluated by plain radiograph
  • 6-month postoperative degree of bone healing evaluated by plain radiograph [ Time Frame: 6-month postoperative ]
    Degree of bone healing evaluated by plain radiograph
  • 12-month postoperative degree of bone healing evaluated by plain radiograph [ Time Frame: 12-month postoperative ]
    Degree of bone healing evaluated by plain radiograph
  • 12-month postoperative degree of bone healing evaluated by computed tomograph [ Time Frame: 12-month postoperative ]
    Degree of bone healing evaluated by computed tomograph
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery
Official Title  ICMJE The Use of Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery: A Randomized Control Trial
Brief Summary This study aims to evaluate the effect of bone marrow concentration on bone healing and spinal fusion by comparing clinical and imaging outcomes between patients receiving transforaminal lumbar intebody fusion with local bone graft and with intraoperative bone marrow concentration and those receiving transforaminal lumbar intebody fusion with local bone graft only.
Detailed Description Spinal arthrodesis has become the mainstay of treatment for severe spinal deformity, spinal instability, spondylolisthesis, and symptomatic degenerative disease. Its primary goal is to develop an osseous bridge between adjacent motion segments to prevent motion, relieve pain, and facilitate neurological recovery. One of the arthrodesis method is transforaminal lumbar intebody fusion. After removal of the problematic disc, iliac crest bone graft was harvested and impacted into the space with cage to facilitate fusion. However, patients are exposed to additional risk of harvesting site, such as pain, infection, wound healing problem or hematomas. Local bone graft harvested from decompression is one of the alternative solutions to avoid these complications. However, the effect of local boen graft is inferior to iliac crest bone graft because iliac crest bone graft contains three important ingredients for successful fusion: osteoconductive scaffold, osteoinductive factors, and the ability to osteogenesis. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, some studies have shown that autologous bone marrow concentration can improve bone healing. In this study, we will add bone marrow concentration into local bone graft during transforaminal lumbar intebody fusion and evaluate the effect of bone marrow concentration on bone healing and spinal fusion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Bone Marrow
  • Spinal Fusion
Intervention  ICMJE
  • Other: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
    Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
  • Other: Transforaminal lumbar interbody fusion with local bone graft
    Transforaminal lumbar interbody fusion with local bone graft
Study Arms  ICMJE
  • Experimental: Bone marrow concentration group
    Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
    Intervention: Other: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
  • Active Comparator: Control group
    Transforaminal lumbar interbody fusion with local bone graft
    Intervention: Other: Transforaminal lumbar interbody fusion with local bone graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • With indication of transforaminal lumbar decomprassion and interbody fusion, ex. spondylolisthesis, symptomatic degenerative disease, spinal instability.
  • Involved levels between T12 and S1
  • Involved levels less than three levels
  • Age between 20 and 70 years

Exclusion Criteria:

  • With prior history of spinal surgery
  • With current or prior history of tumor, trauma or infection at spine
  • With current diagnosis of coagulopathy
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ming-Hsien Hu, MD +886-975611289 minghsienhu@gmail.com
Contact: Pei-Yuan Lee, MD
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03793530
Other Study ID Numbers  ICMJE RD106050
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pei-Yuan Lee, MD, Show Chwan Memorial Hospital
Study Sponsor  ICMJE Pei-Yuan Lee, MD
Collaborators  ICMJE Aeon Biotechnology Corporation
Investigators  ICMJE
Study Chair: Pei-Yuan Lee, MD Show Chwan Memorial Hospital
PRS Account Show Chwan Memorial Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP