Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery

Spinal Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793530
• Other study ID #: RD106050
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Show Chwan Memorial Hospital
• Contact: Ming-Hsien Hu, MD
• Phone: +886-975611289
• Email: minghsienhu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow
• Spinal Fusion

Intervention

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
• Transforaminal lumbar interbody fusion with local bone graft
Transforaminal lumbar interbody fusion with local bone graft

Locations

Country	Name	City	State
Taiwan	Show Chwan Memorial Hospital	Changhua City	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
Pei-Yuan Lee, MD	Aeon Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-month postoperative spinal function evaluated by Oswestry Disability Index	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
Secondary	6-month postoperative spinal function evaluated by Oswestry Disability Index	Subjective evaluation of spinal function by Oswestry Disability Index. Oswestry Disability Index ranges from 0 to 100 and lower score indicates less disability.	6-month postoperative
Secondary	12-month postoperative spinal function evaluated by Oswestry Disability Index	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
Secondary	3-month postoperative degree of pain evaluated by visual analogue scale	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
Secondary	6-month postoperative degree of pain evaluated by visual analogue scale	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
Secondary	12-month postoperative degree of pain evaluated by visual analogue scale	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
Secondary	3-month postoperative degree of bone healing evaluated by plain radiograph	Degree of bone healing evaluated by plain radiograph	3-month postoperative
Secondary	6-month postoperative degree of bone healing evaluated by plain radiograph	Degree of bone healing evaluated by plain radiograph	6-month postoperative
Secondary	12-month postoperative degree of bone healing evaluated by plain radiograph	Degree of bone healing evaluated by plain radiograph	12-month postoperative
Secondary	12-month postoperative degree of bone healing evaluated by computed tomograph	Degree of bone healing evaluated by computed tomograph	12-month postoperative