Bone Graft Materials Observational Registry



Status:Terminated
Conditions:Cancer, Neurology, Orthopedic, Women's Studies, Hematology
Therapuetic Areas:Hematology, Neurology, Oncology, Orthopedics / Podiatry, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/6/2017
Start Date:September 2009
End Date:November 2013

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A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

A multi-center, prospective, observational patient registry to collect information on the
clinical outcomes and "real world" use of approved and commercially available bone graft
substitutes, autograft and allograft.


Inclusion Criteria:

- The patient has failed conservative treatment and is a candidate for spinal fusion
surgery.

- 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 systemic infection or infection at the surgical site.

- 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.
We found this trial at
13
sites
West Bloomfield, Michigan 48322
1951
mi
from 91732
West Bloomfield, MI
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1919
mi
from 91732
Atlanta, GA
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8 Nagy Jenő utca
Budapest, 1126
6204
mi
from 91732
Budapest,
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150 Clinic Avenue
Carrollton, Georgia 30117
1882
mi
from 91732
Carrollton, GA
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217
mi
from 91732
Las Vegas, NV
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1868 Plaudit Place
Lexington, Kentucky 40509
1886
mi
from 91732
Lexington, KY
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910
mi
from 91732
Missoula, MT
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Nashville, Tennessee 37203
1762
mi
from 91732
Nashville, TN
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Plano, Texas 75093
1221
mi
from 91732
Plano, TX
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1635 Divisadero Street
San Francisco, California 94143
356
mi
from 91732
San Francisco, CA
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Southfield, Michigan 48072
1957
mi
from 91732
Southfield, MI
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Syracuse, New York 13214
2322
mi
from 91732
Syracuse, NY
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Worcester, Massachusetts 01605
2540
mi
from 91732
Worcester, MA
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