Bone Graft Materials Observational Registry

Stopped early

Conditions studied: Degenerative Disc Disease, Herniated Disc, Spinal Stenosis, Spondylolithesis, Spinal Deformity, Cervical Myelopathy, Failed Back Surgery Syndrome, Spinal Cord Neoplasms

In brief

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.

Key facts

Study ID

NCT00974623

Run by

Baxter Healthcare Corporation

People needed

329

Starts

2009-09-01

Expected to finish

2013-11-01

Last updated by the study team

2017-04-05

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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