Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
329 participants
OBSERVATIONAL
2009-09-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Spinal Fusion
Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft).
Bone graft substitute, autograft or allograft
spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft
Interventions
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Bone graft substitute, autograft or allograft
spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient is ≥18 years old and of legal age of consent.
* The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
* The patient is skeletally mature (epiphyses closed).
* The patient has signed the IRB approved informed consent.
* The patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years.
Exclusion Criteria
* Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.).
* Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease).
* Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up.
* The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study.
* Patient is participating in another investigational study, which could confound results.
18 Years
ALL
No
Sponsors
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Apatech, Inc.
INDUSTRY
Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Huub Kreuwel, Ph.D
Role: STUDY_DIRECTOR
Director of Medical Affairs
Locations
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UCSF
San Francisco, California, United States
St. Joseph's Hospital - Resurgeons Orthopedics
Atlanta, Georgia, United States
Carrollton Orthopedics
Carrollton, Georgia, United States
Bluegrass Orthopedics & Hand Care Research
Lexington, Kentucky, United States
Arthritis & Joint Center - U. Mass. Memorial
Worcester, Massachusetts, United States
PRESSD
Southfield, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Montana Neuroscience Institute Foundation
Missoula, Montana, United States
Physicians Research Options Spine Center
Las Vegas, Nevada, United States
Syracuse Orthopedic Specialists
Syracuse, New York, United States
Neurosurgical Associates
Nashville, Tennessee, United States
Brain & Spine of Texas
Plano, Texas, United States
Buda Health Center
Budapest, , Hungary
Isala Klinieken
Groot Wezenland, Zwolle, Netherlands
Countries
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Other Identifiers
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APPROACH-001
Identifier Type: -
Identifier Source: org_study_id
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