|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00996073 |
|
Date of registration:
|
09/10/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
|
|
Scientific title:
|
A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Lumbar Interbody Fusion With Instrumentation |
|
Date of first enrolment:
|
September 2009 |
|
Target sample size:
|
24 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00996073 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Roger Brown |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Senior Vice President of Musculoskeletal Repair |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Male or females at least 18 years of age, but not older than 70.
2. Have the ability to understand the requirements of the study, to provide written
informed consent, and to comply with the study protocol.
3. Have the ability to understand and provide written authorization for the use and
disclosure of personal health information (PHI) [per Health Insurance Portability and
Accountability Act (HIPAA) privacy ruling in the US].
4. Have a documented symptomatic diagnosis of DDD at L1-S1 with or without stenosis and
with or without up to and including Grade II degenerative spondylolisthesis.
5. Have clinical symptoms of neurogenic claudication.
6. Have failed 6 months of non-operative low back pain management.
7. Are candidates for posterior lumbar interbody fusion in combination with posterior
pedicle screw stabilization and require surgery at a 1 or 2 adjacent vertebral levels
between L1 and S1.
8. Have a stable screening electrocardiogram (ECG), as determined by the investigator
that would not preclude surgery.
Exclusion Criteria:
1. Female subjects who are pregnant or nursing, or women planning to become pregnant
during the first year (12 months) following surgery.
- Male subjects with partners of childbearing potential must agree to use adequate
contraception (barrier method or abstinence) from the time of surgery and for a
period of at least 1 year after surgery.
2. Have a current or prior history within the last 3 years of neoplasm (excluding basal
cell carcinoma) and/or any active neoplasm within the last 24 months, prior to
screening.
3. Have osteoporosis as defined by a DEXA T score of = -3.0 or a history of fragility
fractures or other significant bone disease contraindicating the use of spinal
instrumentation.
4. Have a documented medical history or radiographic evidence of a metabolic bone disease
or other condition which would negatively impact the bone healing process.
5. Have a positive screen for human immunodeficiency virus (HIV) antibodies.
6. Have had treatment with any investigational therapy or device within 6 months of study
surgery and/or plans to participate in any other allogeneic stem cell/progenitor cell
therapy trial during the 3-year follow-up period.
7. Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion
surgery.
8. Have a body mass index (BMI) > 35.
9. Have 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has
antibody specificities to donor HLA antigens.
10. Are transient or has been treated in the last 6 months before enrollment for alcohol
and/or drug abuse in an inpatient substance abuse program.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Degenerative Disc Disease
|
|
Spinal Stenosis
|
|
Degenerative Spondylolisthesis
|
|
Intervention(s)
|
|
Biological: Lumbar Interbody Fusion with Autograft
|
|
Biological: Lumbar Interbody Fusion with NeoFuse
|
|
Primary Outcome(s)
|
|
To determine the overall safety of NeoFuse plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
[Time Frame: 3 years]
|
|
Secondary Outcome(s)
|
|
To evaluate the overall fusion success with NeoFuse plus carrier compared to autograft using CT scans and x-ray of the involved lumbar spine levels and assess the change in outcomes (ODI, SF-36, and WPAI) and pain (VAS)at the 12-month follow-up visit.
[Time Frame: 3 years]
|
|
Secondary ID(s)
|
|
MSB-SF003
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|