Back to resultsStudy of Nucel for One and Two Level Lumbar Interbody Fusion
Primary Purpose
Degenerative Disc Disease, Spondylolisthesis, Spondylosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One or two level lumbar interbody fusion surgery
Nucel
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
- Be between 18 and 75 years of age
- Have clinical and/or radiological evidence of stenosis, spondylolisthesis, spondylosis or degenerative disc disease, or at either one or two levels of lumbar spine.
- In the opinion of the treating surgeon, must already be a qualified candidate for interbody lumbar fusion surgery with supplemental fixation.
- Be likely to return for regular follow-ups until the end of the study period.
- Be willing and able to provide Informed Consent for study participation.
Exclusion Criteria:
- Previous lumbar spine fusion surgery at operative level.
- Back pain due to acute trauma.
- Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
- No chronic steroid or chronic prescription NSAID use within three (3) months prior to surgery.
- Any active malignancy, infectious process, or documented chronic autoimmune disease.
- Any other concurrent medical disease or treatment that might impair normal healing process.
- Recent history (within past 6 months) of any chemical or alcohol dependence.
- Morbid obesity (BMI > 40).
- Currently a prisoner.
- Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
- Pregnancy at the time of enrollment or planned pregnancy, which would interfere with follow-up imaging.
Sites / Locations
- Florida Orthopaedic Insitute
- Spine Institute of Louisiana
- Carolina Neurosurgery & Spine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nucel treatment group
Arm Description
One or two level lumbar interbody fusion surgery with Nucel
Outcomes
Primary Outcome Measures
Fusion rate using non-contrast CT of the lumbar spine
Fusion will be assessed 2 years by independent radiologist using alpha-numeric grading scale to quantify bone growth and supplemental fixation quality
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02808234
Brief Title
Study of Nucel for One and Two Level Lumbar Interbody Fusion
Official Title
A Single-arm, Prospective, Multi-center Study of Nucel® in Patients Receiving Interbody Fusion for One and Two Level Degenerative Disease of the Lumbar Spine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organogenesis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a prospective non-randomized multi-center feasibility clinical trial to establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody fusion procedures.
Detailed Description
Two hundred non-randomized subjects will participate in the study at up to ten clinical sites in the United States. Participants will be between 18 and 75 years of age. All subjects will have been established with lumbar spine disease at one or two levels of the lumbar spine that requires lumbar interbody fusion procedure as per the opinion of the treating surgeon. The diseases included in the study are spondylosis, degenerative disc disease and spondylolisthesis. All subjects who meet the inclusion criteria and do not meet the exclusion criteria and who elect to participate and sign the informed consent will be included in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spondylolisthesis, Spondylosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nucel treatment group
Arm Type
Other
Arm Description
One or two level lumbar interbody fusion surgery with Nucel
Intervention Type
Procedure
Intervention Name(s)
One or two level lumbar interbody fusion surgery
Intervention Description
One or two level lumbar interbody fusion surgery with allograft derived from human amnion and amniotic fluid.
Intervention Type
Other
Intervention Name(s)
Nucel
Intervention Description
Allograft derived from human amnion and amniotic fluid
Primary Outcome Measure Information:
Title
Fusion rate using non-contrast CT of the lumbar spine
Description
Fusion will be assessed 2 years by independent radiologist using alpha-numeric grading scale to quantify bone growth and supplemental fixation quality
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Neurologic Exam
Description
Physician conducted neurological exam
Time Frame
2 years
Title
Visual Analogue Scale
Description
Patient health outcome survey
Time Frame
2 years
Title
Oswestry Low Back Pain Disability Index
Description
Patient health outcome survey
Time Frame
2 years
Title
SF-12 health survey
Description
Patient health outcome survey
Time Frame
2 years
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:
Be between 18 and 75 years of age
Have clinical and/or radiological evidence of stenosis, spondylolisthesis, spondylosis or degenerative disc disease, or at either one or two levels of lumbar spine.
In the opinion of the treating surgeon, must already be a qualified candidate for interbody lumbar fusion surgery with supplemental fixation.
Be likely to return for regular follow-ups until the end of the study period.
Be willing and able to provide Informed Consent for study participation.
Exclusion Criteria:
Previous lumbar spine fusion surgery at operative level.
Back pain due to acute trauma.
Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
No chronic steroid or chronic prescription NSAID use within three (3) months prior to surgery.
Any active malignancy, infectious process, or documented chronic autoimmune disease.
Any other concurrent medical disease or treatment that might impair normal healing process.
Recent history (within past 6 months) of any chemical or alcohol dependence.
Morbid obesity (BMI > 40).
Currently a prisoner.
Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
Pregnancy at the time of enrollment or planned pregnancy, which would interfere with follow-up imaging.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierce Nunley, MD
Organizational Affiliation
Spine Institute of Louisiana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Orthopaedic Insitute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Carolina Neurosurgery & Spine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Nucel for One and Two Level Lumbar Interbody Fusion
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