The OsteoStrand Plus Deformity Study

Study Overview
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Brief Summary
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A clinical study evaluating outcomes for patients with spinal deformity.

Detailed Description
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A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.

Official Title
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The OsteoStrand Plus Deformity Study

Conditions
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Spinal Fusion

Intervention / Treatment
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* Procedure: Posterolateral Lumbar Fusion with Demineralized Bone Fibers
* Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic Protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Demineralized Bone Matrix<br>Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM). | Procedure: Posterolateral Lumbar Fusion with Demineralized Bone Fibers<br>* Posterolateral Lumbar Fusion with Demimeralized Bone Fibers<br>|
| Active Comparator: Bone Morphogenic Protein<br>Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP). | Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic Protein<br>* Posterolateral Lumbar Fusion with Bone Morphogenic Protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort | Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes | Oswestry Disability Index (ODI) | 24 Months |