Degenerative Disc Disease
Conditions
Keywords
lumbar spine fusion
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.
Interventions
BIOLOGICALNatural Matrix Protein (NMP)
human bone allograft
Sponsors
Induce Biologics USA Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic fusion rate | 12-months post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in disability score assessed by the 12-Item Short Form Survey version 2 | Baseline to 12 months post-operative | 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. |
| Change in pain score - for the Back | Baseline to 12 months post-operative | 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. |
| Change in pain score - for the Left Leg | Baseline to 12 months post-operative | 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. |
| Change in pain score - for the Right Leg | Baseline to 12 months post-operative | 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. |
| Change in disability score assessed by Oswestry Disability Index | Baseline to 12 months post-operative | 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) |
| Change in neurologic status | Baseline to 12 months post-operative | 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). |
| Revisions/reoperations | Baseline to 12 months post-operative | number of revisions or reoperations performed will be collected and reported. |
| Duration of hospitalization | time of surgery to time of discharge, assessed up to 12 months | number of days in hospital post-operation will be collected and reported. |
| Adverse Events (AE) related to NMP | Baseline to 12 months post-operative | 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. |
Countries
United States
Outcome results
None listed