Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
Conditions
Brief summary
The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels.
Detailed description
The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires. The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria. There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery
Interventions
BIOLOGICALNatural Matrix Protein (NMP) Fibers
human bone allograft
PROCEDURELumbar interbody fusion
Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between L1 and S1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
PROCEDURECervical interbody fusion
Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between C2 and T1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
Sponsors
Induce Biologics USA Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis; 2. Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1; 3. Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers; 4. Subject must be 18 years of age or older at the time of consent; 5. Subject must be willing and able to sign an informed consent document; 6. Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.
Exclusion criteria
1. Subject is under 18 years of age at the time of consent; 2. Subject is 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. Subject is currently imprisoned.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of interbody fusion | Baseline to 12 months post-operative | Flexion and Extensions radiographs will be assessed for fusion at each level to be fused Fusion is defined as: (1) less than 5 degrees of motion by flexion extension X-ray and (2) no radiological features of non-union (radiolucency, implant migration, loss of graft height, supplemental fixation failure). Both fusion criteria have to be met to be considered a fusion success at the index level. |
| Incidence of secondary surgical intervention | Baseline to 12 months post-operative | Secondary surgical interventions (SSI) include revision, re-operation, removal, or supplemental fixation at the index levels |
| Incidence of Adverse Product Related Events | Baseline to 12 months post-operative | the incidence of the following will be reported: bone resorption with cage migration or subsidence, local inflammation with seromas, ectopic bone formation, radiculitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in back pain in lumbar fusion patients | 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 millimeters from the 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 leg pain in lumbar fusion patients | 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 millimeters from the 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. |
| Incidence of bridging bone | Baseline to 12 months post-operative | Plane radiographs will be evaluated for the presence of bridging bone at each level to be fused. |
| Change in arm pain in cervical fusion patients | 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 millimeters from the 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 neck pain in cervical fusion patients | 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 millimeters from the 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 for lumbar fusion patients 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 disability score for cervical fusion patients assessed by Neck Disability Index | Baseline to 12 months post-operative | Disability will be assessed using the Neck Disability Index (NDI). NDI 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 neck 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) |
Countries
United States
Outcome results
None listed