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

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05972616
• Other study ID #: SIL-2023-NMP
• Status: Enrolling by invitation
• Start date: August 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Induce Biologics USA Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 135
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Biological:
• Natural Matrix Protein (NMP)
human bone allograft

Locations

Country	Name	City	State
United States	Spine Institute of Louisiana	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Induce Biologics USA Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic fusion rate	CT scans will be graded from 0 (no boney ingrowth) to 3 (complete bridging) and A (no evidence of supplemental fixation failure) or B (evidence of supplemental fixation failure).; Fusion will be defined as a CT grade of 3A with less than 3 degrees of motion at the index level on flexion and extension x-rays.	12-months post-surgery
Secondary	Change in disability score assessed by Oswestry Disability Index	Disability will be assessed using the Oswestry Disability Index (ODI). ODI is a questionnaire to collect a patient's responses to questions about perceived function (disability) in 10 everyday activities in patients with acute or chronic low back pain. Each question consists of 6 statements about 1 activity which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest. The scores are combined to a single score from 0 (no disability) to 50 (completely disabled)	Baseline to 12 months post-operative
Secondary	Change in disability score assessed by the 12-Item Short Form Survey version 2	Disability will be assessed by the 12-Item Short Form Survey version 2 (SF-12v2).; The SF-12 is is a questionnaire to collect a patient's responses to 12 questions about their physical and mental health. It is often used as a quality of life measure. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The minimum score for MCS-12 is 3.2 and the maximum score is 77.9. The minimum score for PCS-12 is 9.9 and the maximum score 76.0. The lower the score the worse the health.	Baseline to 12 months post-operative
Secondary	Change in pain score - for the Back	Pain will be assessed by Visual Analogue Scale (VAS) for back pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.	Baseline to 12 months post-operative
Secondary	Change in pain score - for the Left Leg	Pain will be assessed by Visual Analogue Scale (VAS) for left leg pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.	Baseline to 12 months post-operative
Secondary	Change in pain score - for the Right Leg	Pain will be assessed by Visual Analogue Scale (VAS) for right leg pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.	Baseline to 12 months post-operative
Secondary	Adverse Events (AE) related to NMP	All Adverse Events (AE) will be documented in detail and followed to a satisfactory resolution regardless of the cause. The intensity of the adverse event is determined by the investigator using the following definitions: Mild: The AE is commonly asymptomatic or causes minimal symptoms and does not require any active intervention.; Moderate: The AE causes discomfort and requires treatment but does not pose any significant or permanent risk to harm the subject. It may or may not require any intervention.; Severe: Incapacitating with inability to perform usual activities. It is a definite hazard to health, reduced life expectancy, death, or life threatening, necessitates medical or surgical intervention to preclude permanent disability.; The number of mild, moderate and severe AE determined to be related to NMP™ will be collected and reported.	Baseline to 12 months post-operative
Secondary	Change in neurologic status	Neurologic status will be assessed using a grading scale during a physical exam. The patient will be scored by a clinician as to motor strength (0 to 5 paralysis to normal), sensory function based on response to touch and pin prick (0 absent, 1 numbness, 2 normal, 3 hypersensitive) and reflexes (0 absent, 1 diminished, 2 normal, 3 hyperactive, 4 hyperactive with clonus).	Baseline to 12 months post-operative
Secondary	Revisions/reoperations	number of revisions or reoperations performed will be collected and reported.	Baseline to 12 months post-operative
Secondary	Duration of hospitalization	number of days in hospital post-operation will be collected and reported.	time of surgery to time of discharge, assessed up to 12 months