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Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery

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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

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.

Condition or disease Intervention/treatment Phase
Bone Marrow Spinal Fusion Other: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration Other: Transforaminal lumbar interbody fusion with local bone graft Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Use of Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery: A Randomized Control Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: Bone marrow concentration group
Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
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

Active Comparator: Control group
Transforaminal lumbar interbody fusion with local bone graft
Other: Transforaminal lumbar interbody fusion with local bone graft
Transforaminal lumbar interbody fusion with local bone graft




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 3-month postoperative degree of bone healing evaluated by plain radiograph [ Time Frame: 3-month postoperative ]
    Degree of bone healing evaluated by plain radiograph

  7. 6-month postoperative degree of bone healing evaluated by plain radiograph [ Time Frame: 6-month postoperative ]
    Degree of bone healing evaluated by plain radiograph

  8. 12-month postoperative degree of bone healing evaluated by plain radiograph [ Time Frame: 12-month postoperative ]
    Degree of bone healing evaluated by plain radiograph

  9. 12-month postoperative degree of bone healing evaluated by computed tomograph [ Time Frame: 12-month postoperative ]
    Degree of bone healing evaluated by computed tomograph



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793530


Contacts
Contact: Ming-Hsien Hu, MD +886-975611289 minghsienhu@gmail.com
Contact: Pei-Yuan Lee, MD

Locations
Taiwan
Show Chwan Memorial Hospital Recruiting
Changhua City, Changhua, Taiwan, 500
Contact: Ming-Hsien Hu, MD    +886-975611289    minghsienhu@gmail.com   
Sponsors and Collaborators
Pei-Yuan Lee, MD
Aeon Biotechnology Corporation
Investigators
Study Chair: Pei-Yuan Lee, MD Show Chwan Memorial Hospital

Responsible Party: Pei-Yuan Lee, MD, Principal Investigator, Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT03793530     History of Changes
Other Study ID Numbers: RD106050
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Pei-Yuan Lee, MD, Show Chwan Memorial Hospital:
Bone Marrow
Mesenchymal Stromal Cells
spine fusion surgery