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


N/A
18 Years
N/A
Not Enrolling
Both
Degenerative Disc Disease, Herniated Disc, Spinal Stenosis, Spondylolithesis, Spinal Deformity, Cervical Myelopathy, Failed Back Surgery Syndrome, Spinal Cord Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evidence of successful radiographic fusion

Outcome Time Frame:

6 months, 12 months & 24 months

Safety Issue:

No

Principal Investigator

Roz Mazey

Investigator Role:

Study Director

Investigator Affiliation:

Sr. Project Manager

Authority:

United States: Institutional Review Board

Study ID:

APPROACH-001

NCT ID:

NCT00974623

Start Date:

September 2009

Completion Date:

December 2012

Related Keywords:

  • Degenerative Disc Disease
  • Herniated Disc
  • Spinal Stenosis
  • Spondylolithesis
  • Spinal Deformity
  • Cervical Myelopathy
  • Failed Back Surgery Syndrome
  • Spinal Cord Neoplasms
  • Bone growth substitute
  • Autograft
  • Allograft
  • Spine fusion
  • Congenital Abnormalities
  • Bone Marrow Diseases
  • Spinal Cord Diseases
  • Neoplasms
  • Spinal Cord Neoplasms
  • Spinal Stenosis
  • Spondylolisthesis
  • Intervertebral Disk Degeneration
  • Intervertebral Disk Displacement
  • Failed Back Surgery Syndrome

Name

Location

UCSFSan Francisco, California  941430324
St. Joseph's Hospital - Resurgeons OrthopedicsAtlanta, Georgia  30342
Arthritis & Joint Center - U. Mass. MemorialWorcester, Massachusetts  01605
PRESSDSouthfield, Michigan  48072
Montana Neuroscience Institute FoundationMissoula, Montana  59802
Syracuse Orthopedic SpecialistsSyracuse, New York  13215
Neurosurgical AssociatesNashville, Tennessee  37203
Brain & Spine of TexasPlano, Texas  75093
Carrollton OrthopedicsCarrollton, Georgia  30117
Bluegrass Orthopedics & Hand Care ResearchLexington, Kentucky  40509
Henry Ford West Bloomfield HospitalWest Bloomfield, Michigan  48322
Physicians Research Options Spine CenterLas Vegas, Nevada  89144