Degenerative Changes, Spondylosis, Stenosis
Conditions
Keywords
Bone Morphogenetic Protein (BMP), Demineralized bone matrix (DBM), Fusion rates, Interbody fusion, Lumbar spine, Transverse lumbar interbody fusion (TLIF), Patient reported outcomes, Posterolateral lumbar fusion (PLF)
Brief summary
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient cohort.
Detailed description
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion in comparison to a retrospective cohort of Infuse subjects. Infuse subjects were not enrolled in the current study.
Interventions
DEVICEAccell Evo3 Prospective Use
Sponsors
SeaSpine, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are 18 (eighteen) years of age or older at the time of surgery. * Require spinal fusion using TLIF, PLF or PLIF, with the use of an interbody spacer, at 1 to 3 levels between L3-S1. * Willing and able to return for the scheduled follow-up visits, follow post-operative instructions and undergo the required radiographic exams (A/P, Lateral Neutral and Lateral Flexion/Extension X-rays) for up to 3 time points between 6 months and 24 months post-surgery (6±2 months, 12±3 months and 24±4 months post-surgery), including one CT-scan at 12±3 months. * Unresponsive to conservative care over a period of at least 6 months or has signs and/or symptoms that mandate urgent surgical intervention.
Exclusion criteria
* Are long term users of medications (i.e. steroids greater than 2-weeks) that are known to inhibit fusion or bone metabolism at any time within 6 months prior to surgery. Exceptions are inhaled steroids for asthma treatment (i.e. patients on inhaled steroids are allowed), or epidural steroid injections. * Are taking immunosuppressive agents (Cancer chemotherapy, treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs) or are treated with Growth Factors or Insulin at any time within 6 months prior to surgery. * Are being treated with radiotherapy. * Are having medical conditions, known to impact bone metabolism, such as Paget's disease, osteoporosis. * Are smokers and/or nicotine/tobacco users. * Are pregnant, lactating or women wishing to become pregnant. * Are a prisoner. * Are currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints. * Prior spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved e.g. facet saving techniques such as discectomy, laminotomy, and intradiscal procedures. * Use of any other bone graft or bone graft substitute in addition to or in place of Accell Evo3® with the exception of local autograft and/or cancellous bone chips. * Use of routine prophylactic NSAIDS for 3 months post-operatively, but low dose concomitant pain medications e.g. aspirin should be continued and recorded on the Concomitant Pain Medications case report form (CRF).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Levels With Posterolateral Fusion | 12 months | Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately |
Secondary
| Measure | Time frame |
|---|---|
| Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg) | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prospective Accell Evo3
Accell Evo3 prospective study arm | 29 |
| Retrospective Infuse
rh-BMP2 retrospective study arm | 30 |
| Total | 59 |
Baseline characteristics
| Characteristic | Retrospective | Total | Prospective |
|---|---|---|---|
| Age, Customized >18 years old | 30 Participants | 59 Participants | 29 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 participants | 59 participants | 29 participants |
| Sex: Female, Male Female | 17 Participants | 33 Participants | 16 Participants |
| Sex: Female, Male Male | 13 Participants | 26 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 6 / 29 | 6 / 30 |
| serious Total, serious adverse events | 7 / 29 | 2 / 30 |
Outcome results
Primary
Number of Levels With Posterolateral Fusion
Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately
Time frame: 12 months
Population: One level is defined as a spinal segment in the lumbar spine.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Accell Evo3 | Number of Levels With Posterolateral Fusion | 23 levels |
| Infuse | Number of Levels With Posterolateral Fusion | 26 levels |
Secondary
Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg)
Time frame: 12 months
Population: Data were not collected