Cervical Myelopathy, Degenerative Disc Disease, Failed Back Surgery Syndrome, Herniated Disc, Spinal Cord Neoplasms, Spinal Deformity, Spinal Stenosis, Spondylolithesis
Conditions
Keywords
Bone growth substitute, Autograft, Allograft, Spine fusion
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.
Interventions
DEVICEBone graft substitute, autograft or allograft
spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft
Sponsors
Apatech, Inc.
Baxter Healthcare Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of successful radiographic fusion | 6 months, 12 months & 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance or improvement in neurological status, as compared to baseline scores | 6 months 12 months & 24 months |
| Improvement of pain/function in comparison to pre-operative QOL scores | 6 months, 12 months & 24 months |
Countries
Hungary, Netherlands, United States
Outcome results
None listed