NCT02070484

Brief Summary

The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 27, 2018

Completed
Last Updated

September 28, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

February 21, 2014

Results QC Date

April 13, 2018

Last Update Submit

August 28, 2018

Conditions

Lumbar Degenerative Disc DiseaseSpinal StenosisSpondylolisthesisSpondylosisIntervertebral Disk DisplacementIntervertebral Disk DegenerationSpinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysis

Keywords

NuCelLumbar SpineDegenerative DiseaseEfficacyFusion

Outcome Measures

Primary Outcomes (6)

  • Oswestry Disability Index

    The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.

    12 months

  • Oswestry Disability Index

    The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.

    Baseline

  • Oswestry Disability Index

    The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.

    1 month

  • Oswestry Disability Index

    The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.

    2 months

  • Oswestry Disability Index

    The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.

    3 months

  • Oswestry Disability Index

    The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.

    6 months

Secondary Outcomes (1)

  • Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion

    6 and 12 months

Study Arms (2)

NuCel

EXPERIMENTAL

Stemcell allograft

Biological: NuCel

Demineralized Bone Matrix (DBM)

ACTIVE COMPARATOR

Demineralized Bone Matrix (DBM) bone graft substitute

Biological: Demineralized Bone Matrix

Interventions

NuCelBIOLOGICAL
NuCel
Demineralized Bone MatrixBIOLOGICAL
Demineralized Bone Matrix (DBM)

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18 and 75 years
  • Symptomatic, single-level degenerative lumbar disc disease, spondylosis or spondylolisthesis
  • Failed conservative treatments
  • Low risk for non-union
  • Must be candidates for single-level, posteriolateral lumbar spine fusion
  • Must be able and willing to give Informed Consent
  • English-speaking

You may not qualify if:

  • Smoker (any smoking ≤3 months prior to consent); (Patel et al. 2013)
  • Patients with poorly controlled diabetes mellitus (HgbA1c \> 7%)
  • Documented osteoporosis
  • Prior lumbar spinal surgery at the same spinal level, or immediately adjacent spine level, to the level being operated on
  • Back pain due to infection, tumour, or metabolic bone disease
  • Terminal disease, such as HIV infection, neoplasm
  • Autoimmune disease, such as rheumatoid arthritis
  • Morbid obesity (body mass index (BMI) of 35 kg/m2)
  • Major psychiatric illness in the last year
  • History of alcohol or drug abuse in the last year
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Grant Medical Center

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal StenosisSpondylolisthesisSpondylosisIntervertebral Disc DisplacementSpinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysis

Interventions

Grafton demineralized bone matrix gel

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Josepha Shehadi, MD
Organization
OhioHealth
joseph@drshehadi.com
614-220-5648

Study Officials

  • Joseph Shehadi, MD

    OhioHealth

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2014

First Posted

February 25, 2014

Study Start

February 1, 2014

Primary Completion

March 24, 2017

Study Completion

March 24, 2017

Last Updated

September 28, 2018

Results First Posted

August 27, 2018

Record last verified: 2018-08

Locations

US(2)