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Clinical Trials/NCT03793530
NCT03793530UnknownNot Applicable

The Use of Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery: A Randomized Control Trial

Pei-Yuan Lee, MD1 site in 1 country40 target enrollmentStarted: August 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
3-month postoperative spinal function evaluated by Oswestry Disability Index

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Bone marrow concentration group

Experimental

Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration

Intervention: Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration (Other)

Control group

Active Comparator

Transforaminal lumbar interbody fusion with local bone graft

Intervention: Transforaminal lumbar interbody fusion with local bone graft (Other)

Outcomes

Primary Outcomes

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 Outcomes

  • 3-month postoperative degree of pain evaluated by visual analogue scale(3-month postoperative)
  • 3-month postoperative degree of bone healing evaluated by plain radiograph(3-month postoperative)
  • 12-month postoperative spinal function evaluated by Oswestry Disability Index(12-month postoperative)
  • 12-month postoperative degree of pain evaluated by visual analogue scale(12-month postoperative)
  • 12-month postoperative degree of bone healing evaluated by plain radiograph(12-month postoperative)
  • 12-month postoperative degree of bone healing evaluated by computed tomograph(12-month postoperative)
  • 6-month postoperative spinal function evaluated by Oswestry Disability Index(6-month postoperative)
  • 6-month postoperative degree of pain evaluated by visual analogue scale(6-month postoperative)
  • 6-month postoperative degree of bone healing evaluated by plain radiograph(6-month postoperative)

Investigators

Sponsor
Pei-Yuan Lee, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Pei-Yuan Lee, MD

Principal Investigator

Show Chwan Memorial Hospital

Study Sites (1)

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