The OsteoStrand Plus Deformity Study

SeaSpine

Status: Active, not recruiting

Conditions: Spinal Fusion

Treatments: Procedure: Posterolateral Lumbar Fusion with Demineralized Bone Fibers; Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic Protein

Study type: Interventional

Funder types: Industry

Identifiers

NCT04629794

SS-OS-1802

Details and patient eligibility

About

A clinical study evaluating outcomes for patients with spinal deformity.

Full description

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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Demineralized Bone Matrix

Active Comparator group

Description:

Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM).

Treatment:

Procedure: Posterolateral Lumbar Fusion with Demineralized Bone Fibers

Bone Morphogenic Protein

Active Comparator group

Description:

Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP).

Treatment:

Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic Protein