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NCT04629794 Clinical Trial

The OsteoStrand Plus Deformity Study

Spinal Fusion Clinical Trial

Official title:
The OsteoStrand Plus Deformity Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04629794
Other study ID # SS-OS-1802
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 5, 2020
Est. completion date June 30, 2024

Study information
Verified date March 2023
Source SeaSpine, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A clinical study evaluating outcomes for patients with spinal deformity.

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 28
Est. completion date June 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Posterolateral Lumbar Fusion with Demineralized Bone Fibers
Posterolateral Lumbar Fusion with Demimeralized Bone Fibers
• Posterolateral Lumbar Fusion with Bone Morphogenic Protein
Posterolateral Lumbar Fusion with Bone Morphogenic Protein

Locations
Country Name City State
United States Sonoran Spine Tempe Arizona

Sponsors (1)
Lead Sponsor Collaborator
SeaSpine, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Clinical outcomes Oswestry Disability Index (ODI) 24 Months
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