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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-02-21

Brief Summary

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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.

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Detailed Description

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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

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Degenerative Disc Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Natural Matrix Protein (NMP)

Intervention Type BIOLOGICAL

human bone allograft

Interventions

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Natural Matrix Protein (NMP)

human bone allograft

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No