Clinical Trial Finder

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

Study Purpose

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 adjacent levels.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis; 2. 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; 3. Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers; 4. Subject must be 18 years of age or older at the time of consent; 5. Subject must be willing and able to sign an informed consent document; 6. 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.

Exclusion Criteria:

1. Subject is under 18 years of age at the time of consent; 2. 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; 3. Subject is currently imprisoned.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06000319
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Induce Biologics USA Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Mark A Prevost Sr, MDMark A Prevost II, MD
Principal Investigator Affiliation Southern Orthopedic Sports Medicine AssociatesSouthern Orthopedic Sports Medicine Associates
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
Additional Details

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

Arms & Interventions

Arms

: 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

: 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

Interventions

Biological: - Natural Matrix Protein (NMP) Fibers

human bone allograft

Procedure: - Lumbar interbody fusion

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.

Procedure: - Cervical interbody fusion

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Jasper, Alabama

Status

Address

Southern Orthopedic Sports Medicine Associates

Jasper, Alabama, 35501

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