Clinical trial NCT05972616: Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion
Official title: A Single-center Review of the Performance of Induce Biologics NMP™ in Patients Who Have Undergone Interbody Fusion for Degenerative Disease of the Lumbar Spine
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Degenerative Disc Disease
Keywords: lumbar spine fusion
Lead sponsor: Induce Biologics USA Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Radiographic fusion rate
timeFrame: 12-months post-surgery
Secondary outcomes:
measure: Change in disability score assessed by Oswestry Disability Index
timeFrame: Baseline to 12 months post-operative
measure: Change in disability score assessed by the 12-Item Short Form Survey version 2
timeFrame: Baseline to 12 months post-operative
measure: Change in pain score - for the Back
timeFrame: Baseline to 12 months post-operative
measure: Change in pain score - for the Left Leg
timeFrame: Baseline to 12 months post-operative
measure: Change in pain score - for the Right Leg
timeFrame: Baseline to 12 months post-operative
measure: Adverse Events (AE) related to NMP
timeFrame: Baseline to 12 months post-operative
measure: Change in neurologic status
timeFrame: Baseline to 12 months post-operative
measure: Revisions/reoperations
timeFrame: Baseline to 12 months post-operative
measure: Duration of hospitalization
timeFrame: time of surgery to time of discharge, assessed up to 12 months
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
Study officials:
affiliation: Spine Institute of Louisiana
name: Pierce Nunley, MD
role: PRINCIPAL_INVESTIGATOR
References: