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

Induce Biologics

Status: Invitation-only

Conditions: Degenerative Disc Disease; Spinal Stenosis; Degenerative Spondylolisthesis

Treatments: Biological: Natural Matrix Protein (NMP) Fibers; Procedure: Lumbar interbody fusion; Procedure: Cervical interbody fusion

Study type: Observational

Funder types: Industry

Identifiers

NCT06000319

CT-NMP-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

200 participants in 2 patient groups

Lumbar Interbody Fusion with NMP

Description:

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

Treatment:

Procedure: Lumbar interbody fusion

Biological: Natural Matrix Protein (NMP) Fibers

Cervical Interbody Fusion with NMP

Description:

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

Treatment:

Procedure: Cervical interbody fusion

Biological: Natural Matrix Protein (NMP) Fibers