Status:
TERMINATED
Bone Graft Materials Observational Registry
Lead Sponsor:
Baxter Healthcare Corporation
Collaborating Sponsors:
Apatech, Inc.
Conditions:
Degenerative Disc Disease
Herniated Disc
Eligibility:
All Genders
18+ years
Brief Summary
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, autograf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT00974623
Start Date
September 1 2009
End Date
November 1 2013
Last Update
April 5 2017
Active Locations (14)
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1
UCSF
San Francisco, California, United States, 94143
2
St. Joseph's Hospital - Resurgeons Orthopedics
Atlanta, Georgia, United States, 30342
3
Carrollton Orthopedics
Carrollton, Georgia, United States, 30117
4
Bluegrass Orthopedics & Hand Care Research
Lexington, Kentucky, United States, 40509