Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion

Induce Biologics

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Biological: Natural Matrix Protein (NMP)

Study type: Observational

Funder types: Industry

Identifiers

NCT05972616

SIL-2023-NMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
2. Have been treated with Induce Biologics NMP™ during a lumbar spinal fusion procedure.
3. Be at least 18 years of age.
4. Have current contact information.
5. Be willing and able to provide written Informed Consent for the prospective part of study participation.
6. Be willing and able to undergo a CT-scan and X-rays.
7. Be willing and able to complete patient centered outcome questionnaires.

Exclusion criteria

1. Currently imprisoned.
2. 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. X-rays or CT-scan are contraindicated.
4. Any previous lumbar fusion or arthroplasty surgery at the index level(s)

Trial design

53 participants in 1 patient group

NMP

Description:

Have clinical or radiological evidence of degenerative disc disease of the lumbar spine. Have been treated with NMP™ during a lumbar spinal fusion procedure.

Treatment:

Biological: Natural Matrix Protein (NMP)