Degenerative Disc DiseaseNCT06000319

Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

An observational study of Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Induce Biologics USA Inc. at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
What is being tested?: Natural Matrix Protein (NMP) Fibers, Lumbar interbody fusion and Cervical interbody fusion
Type of treatment: Surgery or procedure
How many people: 200 participants
Where: 1 siteUnited States
Study dates: 4 Jan 2024to 1 Aug 2027
Phase: Observational
Are there results?: Not yet: the study is under way

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 200 patients who have been treated with Induce Biologics NMP™ during cervical or lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study. It is expected that enrollment will take 12 months to complete.

Who may be able to join

Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
Subject must be 18 years of age or older at the time of consent;
Subject must be willing and able to sign an informed consent document;
Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.

Who cannot join

Subject is under 18 years of age at the time of consent;
Subject is 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;
Subject is currently imprisoned.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Alabama Back Institute
Jasper, Alabama, 35501

Other trials in United States

About this study

Official title: Prospective Evaluation of Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

Read the detailed description

The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires.

The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria.

There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery

Conditions: Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
Being tested: Natural Matrix Protein (NMP) Fibers, Lumbar interbody fusion, Cervical interbody fusion
Medical subject headings: Intervertebral Disc Degeneration, Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Natural Matrix Protein (NMP) FibersBiological
human bone allograft
Lumbar interbody fusionProcedure or surgery
Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between L1 and S1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
Cervical interbody fusionProcedure or surgery
Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between C2 and T1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.

Study groups in NCT06000319
Study group	Role	What they receive
Lumbar Interbody Fusion with NMP		Subject has undergone lumbar interbody spine fusion at no more than 3 adjacent levels between L1 and S1 where NMP fibers have been used as a bone void filler Receives: Biological: Natural Matrix Protein (NMP) Fibers; Procedure: Lumbar interbody fusion
Cervical Interbody Fusion with NMP		Subject has undergone cervical interbody spine fusion at no more than 3 adjacent levels between C2 and T1 where NMP fibers have been used as a bone void filler Receives: Biological: Natural Matrix Protein (NMP) Fibers; Procedure: Cervical interbody fusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of interbody fusion
Flexion and Extensions radiographs will be assessed for fusion at each level to be fused Fusion is defined as: (1) less than 5 degrees of motion by flexion extension X-ray and (2) no radiological features of non-union (radiolucency, implant migration, loss of graft height, supplemental fixation failure). Both fusion criteria have to be met to be considered a fusion success at the index level.
Measured: Baseline to 12 months post-operative
Incidence of secondary surgical intervention
Secondary surgical interventions (SSI) include revision, re-operation, removal, or supplemental fixation at the index levels
Measured: Baseline to 12 months post-operative
Incidence of Adverse Product Related Events
the incidence of the following will be reported: bone resorption with cage migration or subsidence, local inflammation with seromas, ectopic bone formation, radiculitis.
Measured: Baseline to 12 months post-operative

Secondary outcomes (7)

Incidence of bridging bone
Plane radiographs will be evaluated for the presence of bridging bone at each level to be fused.
Measured: Baseline to 12 months post-operative
Change in disability score for lumbar fusion patients 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 for cervical fusion patients assessed by Neck Disability Index
Disability will be assessed using the Neck Disability Index (NDI). NDI 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 neck 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 back pain in lumbar fusion patients
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 millimeters from the 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 leg pain in lumbar fusion patients
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 millimeters from the 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 neck pain in cervical fusion patients
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 millimeters from the 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 arm pain in cervical fusion patients
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 millimeters from the 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 20241 Aug 2027

First posted21 Aug 2023
Study start4 Jan 2024
Primary completion1 Feb 2027 (estimated)
Study completion1 Aug 2027 (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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06000319
Sponsor's protocol ID: CT-NMP-001
Status last verified: Nov 2025
First submitted: 25 Jul 2023
Last updated: 18 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
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Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
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Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
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All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Evaluation of Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
ClinicalTrials.gov ID: NCT06000319
Acronym / sponsor ID: CT-NMP-001
Conditions: Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 200 participants (estimated)
Lead sponsor: Induce Biologics USA Inc.Industry (pharma, biotech, devices)
Study start: 4 Jan 2024 (actual)
Primary completion: 1 Feb 2027 (estimated)
Study completion: 1 Aug 2027 (estimated)
First posted: 21 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.

Detailed description

The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires.

There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Lumbar Interbody Fusion with NMP	–	Biological: Natural Matrix Protein (NMP) Fibers, Procedure: Lumbar interbody fusionSubject has undergone lumbar interbody spine fusion at no more than 3 adjacent levels between L1 and S1 where NMP fibers have been used as a bone void filler
Cervical Interbody Fusion with NMP	–	Biological: Natural Matrix Protein (NMP) Fibers, Procedure: Cervical interbody fusionSubject has undergone cervical interbody spine fusion at no more than 3 adjacent levels between C2 and T1 where NMP fibers have been used as a bone void filler

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 200 patients who have been treated with Induce Biologics NMP™ during cervical or lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study. It is expected that enrollment will take 12 months to complete.

Key inclusion criteria (6 listed)

Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
Subject must be 18 years of age or older at the time of consent;
Subject must be willing and able to sign an informed consent document;

Key exclusion criteria (3 listed)

Subject is under 18 years of age at the time of consent;
Subject is 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;
Subject is currently imprisoned.

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) Fibershuman bone allograft	Biological	Cervical Interbody Fusion with NMP, Lumbar Interbody Fusion with NMP
Lumbar interbody fusionProcedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between L1 and S1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.	Procedure or surgery	Lumbar Interbody Fusion with NMP
Cervical interbody fusionProcedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between C2 and T1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.	Procedure or surgery	Cervical Interbody Fusion with NMP

Primary outcome

Incidence of interbody fusion
Time frame: Baseline to 12 months post-operative
Flexion and Extensions radiographs will be assessed for fusion at each level to be fused Fusion is defined as: (1) less than 5 degrees of motion by flexion extension X-ray and (2) no radiological features of non-union (radiolucency, implant migration, loss of graft height, supplemental fixation failure). Both fusion criteria have to be met to be considered a fusion success at the index level.
Incidence of secondary surgical intervention
Time frame: Baseline to 12 months post-operative
Secondary surgical interventions (SSI) include revision, re-operation, removal, or supplemental fixation at the index levels
Incidence of Adverse Product Related Events
Time frame: Baseline to 12 months post-operative
the incidence of the following will be reported: bone resorption with cage migration or subsidence, local inflammation with seromas, ectopic bone formation, radiculitis.

7 secondary outcomes

Incidence of bridging bone
Time frame: Baseline to 12 months post-operative
Change in disability score for lumbar fusion patients assessed by Oswestry Disability Index
Time frame: Baseline to 12 months post-operative
Change in disability score for cervical fusion patients assessed by Neck Disability Index
Time frame: Baseline to 12 months post-operative
Change in back pain in lumbar fusion patients
Time frame: Baseline to 12 months post-operative
Change in leg pain in lumbar fusion patients
Time frame: Baseline to 12 months post-operative
Change in neck pain in cervical fusion patients
Time frame: Baseline to 12 months post-operative
Change in arm pain in cervical fusion patients
Time frame: Baseline to 12 months post-operative

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Individual participant dataSharing planned: No

Related trials for Degenerative Disc Disease

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

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.

Mark A Prevost Sr, MD principal investigator

Alabama Back Institute

Mark A Prevost II, MD principal investigator

Alabama Back Institute

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 and Degenerative Spondylolisthesis, 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 6 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 18 Nov 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?

This study is still under way. Results are not available in the source record yet.

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?

Incidence of interbody fusion (time frame: Baseline to 12 months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06000319.

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 18 Nov 2025.