Degenerative Changes, Spondylosis, Stenosis
Conditions
Brief summary
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral 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 posterolateral spine fusion with a retrospective comparison to a historical patient cohort. The historical patient cohort has not been previously published and therefore, no reference to this group can be provided.
Interventions
Accell Evo3 in posteriolateral fusion (prospective cohort)
DEVICErh-BMP2
rh-BMP2 in posterolateral fusion (retrospective cohort)
Sponsors
SeaSpine, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years of age or older at the time of surgery * Require spinal fusion using posterior Transforaminal Lumbar Interbody Fusion (TLIF), Posterolateral Fusion (PLF) or Posterior Lumber Interbody Fusion (PLIF) in 1 to 3 levels between L3-S1 * Follow-up radiographic imaging post surgery
Exclusion criteria
* Long term users of medications known to inhibit fusion,bone metabolism or epidural steroid injections * Immunosuppressive agents, Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs, Growth Factors or Insulin * Treated with radiotherapy since their surgery * Medical conditions known to impact bone metabolism, such as Paget's disease, osteoporosis * Pregnant or lactating women or women wishing to become pregnant * Prisoner * Participating in an investigational drug or another device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery | 12 months | Posterolateral fusion by radiographic assessment 12 months post surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsteoSurg 300 Prospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with OsteoSurge 300 in the posterolateral space. | 16 |
| rhBMP-2 Retrospective study arm: All patients underwent fusion with pedicle screw instrumentation, decortication of dorsal bony elements, and placement of local autograft bone, allograft cancellous chips, and biologic augmentation with rhBMP-2 in the posterolateral space. | 21 |
| Total | 37 |
Baseline characteristics
| Characteristic | OsteoSurg 300 | rhBMP-2 | Total |
|---|---|---|---|
| Age, Customized participants over 18 years of age | 16 Participants | 21 Participants | 37 Participants |
| Region of Enrollment United States | 16 Participants | 21 Participants | 37 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 21 |
| other Total, other adverse events | 9 / 16 | 15 / 21 |
| serious Total, serious adverse events | 5 / 16 | 3 / 21 |
Outcome results
Primary
Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
Posterolateral fusion by radiographic assessment 12 months post surgery
Time frame: 12 months
Population: One to 3 spinal levels between L3 and S1 were treated per patient. Fusion was assessed twice per treated level. There were 23 OsteoSurge 300 levels and 37 rhBMP-2 levels but 46 OsteoSurge assessments and 74 rhBMP-2 assessments.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OsteoSurg 300 | Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery | 43 radiographic assessments |
| rhBMP-2 | Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery | 74 radiographic assessments |