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Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease

Primary Purpose

Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NuCel
Demineralized Bone Matrix
Sponsored by
OhioHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Degenerative Disc Disease focused on measuring NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Riverside Methodist Hospital
  • Grant Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NuCel

Demineralized Bone Matrix (DBM)

Arm Description

Stemcell allograft

Demineralized Bone Matrix (DBM) bone graft substitute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion
CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.

Full Information

First Posted
February 21, 2014
Last Updated
August 28, 2018
Sponsor
OhioHealth
Collaborators
NuTech Medical, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02070484
Brief Title
Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
Official Title
Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 24, 2017 (Actual)
Study Completion Date
March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OhioHealth
Collaborators
NuTech Medical, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis, Intervertebral Disk Displacement, Intervertebral Disk Degeneration, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases, Spondylolysis
Keywords
NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NuCel
Arm Type
Experimental
Arm Description
Stemcell allograft
Arm Title
Demineralized Bone Matrix (DBM)
Arm Type
Active Comparator
Arm Description
Demineralized Bone Matrix (DBM) bone graft substitute
Intervention Type
Biological
Intervention Name(s)
NuCel
Intervention Type
Biological
Intervention Name(s)
Demineralized Bone Matrix
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame
12 months
Title
Oswestry Disability Index
Description
The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame
Baseline
Title
Oswestry Disability Index
Description
The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame
1 month
Title
Oswestry Disability Index
Description
The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame
2 months
Title
Oswestry Disability Index
Description
The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame
3 months
Title
Oswestry Disability Index
Description
The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion
Description
CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Shehadi, MD
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease

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