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

Last updated: July 24, 2023
Sponsor: Induce Biologics USA Inc.
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Natural Matrix Protein (NMP)

Clinical Study ID

NCT05972616
SIL-2023-NMP
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have clinical or radiological evidence of degenerative disc disease of the lumbarspine.
  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 ofstudy 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

Exclusion Criteria:

  1. Currently imprisoned.
  2. Currently experiencing major mental illness (psychosis, schizophrenia, major affectivedisorder) which in the opinion of the investigator may indicate that the symptoms arepsychological 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)

Study Design

Total Participants: 135
Treatment Group(s): 1
Primary Treatment: Natural Matrix Protein (NMP)
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Spine Institute of Louisiana

    Shreveport, Louisiana 71101
    United States

    Site Not Available

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