Degenerative Disc DiseaseNCT02808234
Study of Nucel for One and Two Level Lumbar Interbody Fusion
A study testing One or two level lumbar interbody fusion surgery and Nucel in people with Degenerative Disc Disease and Spondylolisthesis, run by Organogenesis at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Spondylosis
- What is being tested?
- One or two level lumbar interbody fusion surgery and Nucel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2015to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carolina Neurosurgery & Spine
Charlotte, North Carolina, 28204
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Florida Orthopaedic Insitute
Tampa, Florida, 33609
About this study
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
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.
Read the 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.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spondylosis
- Being tested
- One or two level lumbar interbody fusion surgery, Nucel
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One or two level lumbar interbody fusion surgeryProcedure or surgery
One or two level lumbar interbody fusion surgery with allograft derived from human amnion and amniotic fluid.
NucelOther
Allograft derived from human amnion and amniotic fluid
| Study group | Role | What they receive |
|---|---|---|
| Nucel treatment group | Other | One or two level lumbar interbody fusion surgery with Nucel Receives: Procedure: One or two level lumbar interbody fusion surgery; Other: Nucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierce Nunley, MD, Principal investigator, Spine Institute of Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808234
- Sponsor's protocol ID
- Nucel-2015-03
- Status last verified
- May 2021
- First submitted
- 7 Jun 2016
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02808234
- Acronym / sponsor ID
- Nucel-2015-03
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spondylosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nucel treatment group | Other | Procedure: One or two level lumbar interbody fusion surgery, Other: NucelOne or two level lumbar interbody fusion surgery with Nucel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One or two level lumbar interbody fusion surgeryOne or two level lumbar interbody fusion surgery with allograft derived from human amnion and amniotic fluid. | Procedure or surgery | Nucel treatment group |
| NucelAllograft derived from human amnion and amniotic fluid | Other | Nucel treatment group |
Primary outcome
Fusion rate using non-contrast CT of the lumbar spine
Time frame: 2 years
Fusion will be assessed 2 years by independent radiologist using alpha-numeric grading scale to quantify bone growth and supplemental fixation quality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierce Nunley, MD principal investigator
Spine Institute of Louisiana
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One or two level lumbar interbody fusion surgery and Nucel in people with Degenerative Disc Disease and Spondylolisthesis, run by Organogenesis at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion rate using non-contrast CT of the lumbar spine (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.