Spinal Fusion
Conditions
Brief summary
A clinical study evaluating outcomes for patients with spinal deformity.
Detailed description
A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.
Interventions
PROCEDUREPosterolateral Lumbar Fusion with Demineralized Bone Fibers
Posterolateral Lumbar Fusion with Demimeralized Bone Fibers
PROCEDUREPosterolateral Lumbar Fusion with Bone Morphogenic Protein
Posterolateral Lumbar Fusion with Bone Morphogenic Protein
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
-≥18 years of age * Indicated for deformity correction surgery * Require spinal fusion at four or more levels * Are willing to return for follow-up visits * Willing to sign the Informed Consent Forms
Exclusion criteria
* Uncontrolled diabetes * Morbid obesity * history of alcohol or drug abuse * Corticosteroid use * Fever or leukocytosis * Systemic infection * Active malignancy * Elevation of white blood cell count * Osteoporosis * Disease of bone metabolism * Unsuitable or insufficient bone support * Skeletal immaturity * Prior fusion * Use of steroids, immune suppressants, osteoporosis medications * Use of internal bone stimulators * Institutionalized or a prisoner * Undergoing (Undergone) a worker's compensation case * Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration) * Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study * Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort | 12 Months | Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | 24 Months | Oswestry Disability Index (ODI) |
Countries
United States
Outcome results
None listed