Bone Graft Materials Observational Registry

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: Bone graft substitute, autograft or allograft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spinal Fusion<br>Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft). | Device: Bone graft substitute, autograft or allograft<br>* spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft<br>* Other names: Messenchymal stem cell therapies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of successful radiographic fusion |  | 6 months, 12 months & 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone growth substitute, Autograft, Allograft, Spine fusion