The OsteoStrand Plus Deformity Study

Not Applicable

Active, not recruiting

• Conditions: Spinal Fusion
• Interventions: Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic Protein; Procedure: Posterolateral Lumbar Fusion with Demineralized Bone Fibers

• Registration Number: NCT04629794
• Lead Sponsor: SeaSpine, Inc.

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.

Study Timeline

• Study Start: 2020-03-05
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone Morphogenic Protein	Posterolateral Lumbar Fusion with Bone Morphogenic Protein	Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP).
Demineralized Bone Matrix	Posterolateral Lumbar Fusion with Demineralized Bone Fibers	Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical outcomes	24 Months	Oswestry Disability Index (ODI)

Trial Locations

Locations (1)

Sonoran Spine; 🇺🇸 Tempe, Arizona, United States