Clinical trial NCT00974623: Bone Graft Materials Observational Registry
Official title: A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Disc Disease
Herniated Disc
Spinal Stenosis
Spondylolithesis
Spinal Deformity
Cervical Myelopathy
Failed Back Surgery Syndrome
Spinal Cord Neoplasms
Keywords: Bone growth substitute
Autograft
Allograft
Spine fusion
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Apatech, Inc.
First posted: 2009-09-10
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in this study will be identified from the surgeon's medical practice and will include patients who failed conservative care and have been identified as requiring spinal fusion surgery.

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, autograft and allograft.


Eligibility criteria: 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.

Primary outcomes:
measure: Evidence of successful radiographic fusion
timeFrame: 6 months, 12 months & 24 months
Secondary outcomes:
measure: Maintenance or improvement in neurological status, as compared to baseline scores
timeFrame: 6 months 12 months & 24 months
measure: Improvement of pain/function in comparison to pre-operative QOL scores
timeFrame: 6 months, 12 months & 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Atlanta
country: United States
facility: St. Joseph's Hospital - Resurgeons Orthopedics
state: Georgia
city: Carrollton
country: United States
facility: Carrollton Orthopedics
state: Georgia
city: Lexington
country: United States
facility: Bluegrass Orthopedics & Hand Care Research
state: Kentucky
city: Worcester
country: United States
facility: Arthritis & Joint Center - U. Mass. Memorial
state: Massachusetts
city: Southfield
country: United States
facility: PRESSD
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: Missoula
country: United States
facility: Montana Neuroscience Institute Foundation
state: Montana
city: Las Vegas
country: United States
facility: Physicians Research Options Spine Center
state: Nevada
city: Syracuse
country: United States
facility: Syracuse Orthopedic Specialists
state: New York
city: Nashville
country: United States
facility: Neurosurgical Associates
state: Tennessee
city: Plano
country: United States
facility: Brain & Spine of Texas
state: Texas
city: Budapest
country: Hungary
facility: Buda Health Center
city: Groot Wezenland
country: Netherlands
facility: Isala Klinieken
state: Zwolle
Study officials:
affiliation: Director of Medical Affairs
name: Huub Kreuwel, Ph.D
role: STUDY_DIRECTOR
References: