The OsteoStrand Plus Deformity Study

Status unconfirmed · Not applicable

Conditions studied: Spinal Fusion

In brief

A clinical study evaluating outcomes for patients with spinal deformity.

Key facts

Study ID

NCT04629794

Run by

SeaSpine, Inc.

People needed

28

Starts

2020-03-05

Expected to finish

2024-06-30

Last updated by the study team

2023-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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

Where it is running

• Sonoran Spine — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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