Bone Graft Materials Observational Registry (APPROACH-001)

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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

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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