Degenerative Disc DiseaseNCT05972616
Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion
An observational study of Degenerative Disc Disease, run by Induce Biologics USA Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Natural Matrix Protein (NMP)
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 21 Feb 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include up to 135 patients of the Spine Institute of Louisiana (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study
Who may be able to join
- Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
- Have been treated with Induce Biologics NMP™ during a lumbar spinal fusion procedure.
- Be at least 18 years of age.
- Have current contact information.
- Be willing and able to provide written Informed Consent for the prospective part of study participation.
- Be willing and able to undergo a CT-scan and X-rays.
- Be willing and able to complete patient centered outcome questionnaires.
Who cannot join
- Currently imprisoned.
- Currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin.
- X-rays or CT-scan are contraindicated.
- Any previous lumbar fusion or arthroplasty surgery at the index level(s)
Trial locations and contacts
1 site in 1 country.
United States1 site
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
About this study
Official title: A Single-center Review of the Performance of Induce Biologics NMP™ in Patients Who Have Undergone Interbody Fusion for Degenerative Disease of the Lumbar Spine
The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.
Read the detailed description
The study involves a retrospective review of patients' medical records and prospective collection of CT scans, X-rays, and patient centered outcome questionnaires.
The study population will include up to 135 patients of the Spine Institute of Louisiana (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study.
There will be a single Prospective Visit in this study. This visit will be scheduled at the 12-month (± 2 mo) post-surgery time point.
- Conditions
- Degenerative Disc Disease
- Being tested
- Natural Matrix Protein (NMP)
- Keywords
- lumbar spine fusion
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Matrix Protein (NMP)Biological
human bone allograft
| Study group | Role | What they receive |
|---|---|---|
| NMP | Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
Have been treated with NMP™ during a lumbar spinal fusion procedure. Receives: Biological: Natural Matrix Protein (NMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic fusion rate
CT scans will be graded from 0 (no boney ingrowth) to 3 (complete bridging) and A (no evidence of supplemental fixation failure) or B (evidence of supplemental fixation failure).
Fusion will be defined as a CT grade of 3A with less than 3 degrees of motion at the index level on flexion and extension x-rays.
Measured: 12-months post-surgery
Secondary outcomes (9)
Change in disability score assessed by Oswestry Disability Index
Disability will be assessed using the Oswestry Disability Index (ODI). ODI is a questionnaire to collect a patient's responses to questions about perceived function (disability) in 10 everyday activities in patients with acute or chronic low back pain. Each question consists of 6 statements about 1 activity which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest. The scores are combined to a single score from 0 (no disability) to 50 (completely disabled)
Measured: Baseline to 12 months post-operative
Change in disability score assessed by the 12-Item Short Form Survey version 2
Disability will be assessed by the 12-Item Short Form Survey version 2 (SF-12v2).
The SF-12 is is a questionnaire to collect a patient's responses to 12 questions about their physical and mental health. It is often used as a quality of life measure. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The minimum score for MCS-12 is 3.2 and the maximum score is 77.9. The minimum score for PCS-12 is 9.9 and the maximum score 76.0. The lower the score the worse the health.
Measured: Baseline to 12 months post-operative
Change in pain score - for the Back
Pain will be assessed by Visual Analogue Scale (VAS) for back pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.
Measured: Baseline to 12 months post-operative
Change in pain score - for the Left Leg
Pain will be assessed by Visual Analogue Scale (VAS) for left leg pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.
Measured: Baseline to 12 months post-operative
Change in pain score - for the Right Leg
Pain will be assessed by Visual Analogue Scale (VAS) for right leg pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.
Measured: Baseline to 12 months post-operative
Adverse Events (AE) related to NMP
All Adverse Events (AE) will be documented in detail and followed to a satisfactory resolution regardless of the cause. The intensity of the adverse event is determined by the investigator using the following definitions:
Mild: The AE is commonly asymptomatic or causes minimal symptoms and does not require any active intervention.
Moderate: The AE causes discomfort and requires treatment but does not pose any significant or permanent risk to harm the subject. It may or may not require any intervention.
Severe: Incapacitating with inability to perform usual activities. It is a definite hazard to health, reduced life expectancy, death, or life threatening, necessitates medical or surgical intervention to preclude permanent disability.
The number of mild, moderate and severe AE determined to be related to NMP™ will be collected and reported.
Measured: Baseline to 12 months post-operative
Change in neurologic status
Neurologic status will be assessed using a grading scale during a physical exam. The patient will be scored by a clinician as to motor strength (0 to 5 paralysis to normal), sensory function based on response to touch and pin prick (0 absent, 1 numbness, 2 normal, 3 hypersensitive) and reflexes (0 absent, 1 diminished, 2 normal, 3 hyperactive, 4 hyperactive with clonus).
Measured: Baseline to 12 months post-operative
Revisions/reoperations
number of revisions or reoperations performed will be collected and reported.
Measured: Baseline to 12 months post-operative
Duration of hospitalization
number of days in hospital post-operation will be collected and reported.
Measured: time of surgery to time of discharge, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Aug 2023
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Induce Biologics USA Inc.
- 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
- NCT05972616
- Sponsor's protocol ID
- SIL-2023-NMP
- Status last verified
- Oct 2025
- First submitted
- 12 Jul 2023
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Review of the Performance of Induce Biologics NMP™ in Patients Who Have Undergone Interbody Fusion for Degenerative Disease of the Lumbar Spine
- ClinicalTrials.gov ID
- NCT05972616
- Acronym / sponsor ID
- SIL-2023-NMP
- Conditions
- Degenerative Disc Disease
- Keywords
- lumbar spine fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Induce Biologics USA Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 2 Aug 2023 (actual)
- 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 objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.
Detailed description
The study involves a retrospective review of patients' medical records and prospective collection of CT scans, X-rays, and patient centered outcome questionnaires.
The study population will include up to 135 patients of the Spine Institute of Louisiana (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study.
There will be a single Prospective Visit in this study. This visit will be scheduled at the 12-month (± 2 mo) post-surgery time point.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMP | – | Biological: Natural Matrix Protein (NMP)Have clinical or radiological evidence of degenerative disc disease of the lumbar spine. Have been treated with NMP™ during a lumbar spinal fusion procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include up to 135 patients of the Spine Institute of Louisiana (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study
Key inclusion criteria (7 listed)
- Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
- Have been treated with Induce Biologics NMP™ during a lumbar spinal fusion procedure.
- Be at least 18 years of age.
- Have current contact information.
- Be willing and able to provide written Informed Consent for the prospective part of study participation.
Key exclusion criteria (4 listed)
- Currently imprisoned.
- Currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin.
- X-rays or CT-scan are contraindicated.
- Any previous lumbar fusion or arthroplasty surgery at the index level(s)
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 |
|---|---|---|
| Natural Matrix Protein (NMP)human bone allograft | Biological | NMP |
Primary outcome
Radiographic fusion rate
Time frame: 12-months post-surgery
CT scans will be graded from 0 (no boney ingrowth) to 3 (complete bridging) and A (no evidence of supplemental fixation failure) or B (evidence of supplemental fixation failure). Fusion will be defined as a CT grade of 3A with less than 3 degrees of motion at the index level on flexion and extension x-rays.
9 secondary outcomes
Change in disability score assessed by Oswestry Disability Index
Time frame: Baseline to 12 months post-operative
Change in disability score assessed by the 12-Item Short Form Survey version 2
Time frame: Baseline to 12 months post-operative
Change in pain score - for the Back
Time frame: Baseline to 12 months post-operative
Change in pain score - for the Left Leg
Time frame: Baseline to 12 months post-operative
Change in pain score - for the Right Leg
Time frame: Baseline to 12 months post-operative
Adverse Events (AE) related to NMP
Time frame: Baseline to 12 months post-operative
Change in neurologic status
Time frame: Baseline to 12 months post-operative
Revisions/reoperations
Time frame: Baseline to 12 months post-operative
Duration of hospitalization
Time frame: time of surgery to time of discharge, assessed up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Induce Biologics USA Inc. at 1 site 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radiographic fusion rate (time frame: 12-months post-surgery). 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 14 Oct 2025.