NCT03793530

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

3.3 years

First QC Date

January 2, 2019

Last Update Submit

April 11, 2020

Conditions

Bone MarrowSpinal Fusion

Keywords

Bone MarrowMesenchymal Stromal Cellsspine fusion surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 6-month postoperative spinal function evaluated by Oswestry Disability Index

    6-month postoperative

  • 12-month postoperative spinal function evaluated by Oswestry Disability Index

    12-month postoperative

  • 3-month postoperative degree of pain evaluated by visual analogue scale

    3-month postoperative

  • 6-month postoperative degree of pain evaluated by visual analogue scale

    6-month postoperative

  • 12-month postoperative degree of pain evaluated by visual analogue scale

    12-month postoperative

  • +4 more secondary outcomes

Study Arms (2)

Bone marrow concentration group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Transforaminal lumbar interbody fusion with local bone graft

Other: Transforaminal lumbar interbody fusion with local bone graft

Interventions

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

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

Bone marrow concentration group
Transforaminal lumbar interbody fusion with local bone graftOTHER

Transforaminal lumbar interbody fusion with local bone graft

Control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Show Chwan Memorial Hospital

Changhua, Changhua, 500, Taiwan

RECRUITING

Related Publications (1)

  • Hu MH, Tseng YK, Chung YH, Wu NY, Li CH, Lee PY. The efficacy of oral vitamin D supplements on fusion outcome in patients receiving elective lumbar spinal fusion-a randomized control trial. BMC Musculoskelet Disord. 2022 Nov 18;23(1):996. doi: 10.1186/s12891-022-05948-9.

    PMID: 36401234DERIVED

Study Officials

  • Pei-Yuan Lee, MD

    Show Chwan Memorial Hospital

    STUDY CHAIR

Central Study Contacts

Ming-Hsien Hu, MD

CONTACT

+886-975611289minghsienhu@gmail.com

Pei-Yuan Lee, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 4, 2019

Study Start

August 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)