NCT02068547

Brief Summary

The purpose of this research is to test if that combining bone marrow aspirate (removing bone marrow with a needle) concentration with locally harvested (collected) autograft (patient's own bone from another part of the body) for use as the bone graft results in equal rates of a successful procedure (fusion), as compared to current best practice in high-risk patients undergoing posterior cervical fusion. Hypothesis: Bone marrow aspirate concentration combined with locally harvested autograft results in equivalent rates of bony fusion, as compared to current best practice in high-risk patients undergoing posterior cervical decompression and fusion.

Trial Health

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Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 18, 2018

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

February 17, 2014

Results QC Date

March 13, 2018

Last Update Submit

February 8, 2021

Conditions

Cervical MyelopathyRadiculopathy

Keywords

posterior cervical fusionposterior cervical decompression

Outcome Measures

Primary Outcomes (1)

  • Rate of Fusion

    Rate of fusion - (6, 12, and 24 months) Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (\<2mm) and/or by computed tomography (CT) scan at 2 year post-operatively.

    6 months, 12 months, 24 months

Secondary Outcomes (2)

  • Physical and Mental Health From Subject's Point of View

    24 months

  • Neck Pain Affects Every Day Activities

    24 Months

Study Arms (2)

Group 1 - Surigical Best Practice

ACTIVE COMPARATOR

Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)

Biological: locally harvested autograft, demineralized bone matrix, and cadaveric allograft

Group 2 - autograft/BMAC

EXPERIMENTAL

Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.

Biological: Bone Marrow Aspirate

Interventions

locally harvested autograft, demineralized bone matrix, and cadaveric allograftBIOLOGICAL
Group 1 - Surigical Best Practice
Bone Marrow AspirateBIOLOGICAL
Group 2 - autograft/BMAC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75
  • Have at least one of the following high risk qualifications: BMI \>30, Rheumatoid Arthritis, Osteoporosis, Current smoker
  • Able to cooperate in the completion of standardized outcome measures (multiple questionnaires)
  • Willing and able to comply with study protocol
  • Symptomatic cervical myelopathy and/or radiculopathy
  • Scheduled for cervical alignment, allowing management with a posterior approach

You may not qualify if:

  • MRI incompatible device
  • History of prior cervical instrumentation
  • Requires an instrumented anterior cervical fusion
  • History of underlying neurological condition affecting the cervical spine (MS, Amyotrophic Lateral Sclerosis, HIV)
  • Pre-existent neurologic disorder or mental disorder that would preclude accurate evaluation (psychiatric disease, Parkinson's disease, Alzheimer's disease)
  • History of previous cervical fusion at the operative site
  • Pregnant
  • Active malignancy
  • Previous history of posterior cervical decompression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Results Point of Contact

Title
Wilson Z. Ray, MD
Organization
Washington University St. Louis
rayz@wustl.edu
314-362-9959

Study Officials

  • Wilson Z Ray, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 21, 2014

Study Start

February 1, 2014

Primary Completion

April 5, 2017

Study Completion

April 5, 2017

Last Updated

March 2, 2021

Results First Posted

May 18, 2018

Record last verified: 2021-02

Locations

US(2)