Bone Graft Materials Observational Registry (APPROACH-001)

Baxter

Status: Terminated

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

Treatments: Device: Bone graft substitute, autograft or allograft

Study type: Observational

Funder types: Industry

Identifiers

NCT00974623

APPROACH-001

Details and patient eligibility

About

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.

Enrollment: 329 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

329 participants in 1 patient group

Spinal Fusion

Description:

Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft).

Treatment:

Device: Bone graft substitute, autograft or allograft