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Bone Graft Materials Observational Registry (APPROACH-001)
This study is currently recruiting participants.
Verified May 2011 by Apatech, Inc.

First Received on September 8, 2009.   Last Updated on May 20, 2011   History of Changes
Sponsor: Apatech, Inc.
Information provided by: Apatech, Inc.
ClinicalTrials.gov Identifier: NCT00974623
  Purpose

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.


Condition Intervention
Degenerative Disc Disease
Herniated Disc
Spinal Stenosis
Spondylolithesis
Spinal Deformity
Cervical Myelopathy
Failed Back Surgery Syndrome
Spinal Cord Neoplasms
Device: Bone graft substitute, autograft or allograft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

Resource links provided by NLM:


Further study details as provided by Apatech, Inc.:

Primary Outcome Measures:
  • Evidence of successful radiographic fusion [ Time Frame: 6 months, 12 months & 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maintenance or improvement in neurological status, as compared to baseline scores [ Time Frame: 6 months 12 months & 24 months ] [ Designated as safety issue: No ]
  • Improvement of pain/function in comparison to pre-operative QOL scores [ Time Frame: 6 months, 12 months & 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Spinal Fusion
Patients who require and have a planned spinal fusion procedure.
Device: Bone graft substitute, autograft or allograft
spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft
Other Names:
  • Autograft
  • Allograft/DBM
  • Ceramics
  • Synthetics
  • BMP
  • Messenchymal stem cell therapies

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients enrolled in this study will be identified from the surgeon's medical practice and will include patients who failed conservative care and have been identified as requiring spinal fusion surgery.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974623

Contacts
Contact: Trai Curtis 972-635-7440 therasa_curtis@baxter.com

Locations
United States, California
UCSF Recruiting
San Francisco, California, United States, 94143
United States, Georgia
St. Joseph's Hospital - Resurgeons Orthopedics Recruiting
Atlanta, Georgia, United States, 30342
United States, Massachusetts
Arthritis & Joint Center - U. Mass. Memorial Active, not recruiting
Worcester, Massachusetts, United States, 01605
United States, Michigan
PRESSD Recruiting
Southfield, Michigan, United States, 48072
United States, Montana
Montana Neuroscience Institute Foundation Recruiting
Missoula, Montana, United States, 59802
United States, New York
Syracuse Orthopedic Specialists Recruiting
Syracuse, New York, United States, 13215
United States, Tennessee
Neurosurgical Associates Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Brain & Spine of Texas Active, not recruiting
Plano, Texas, United States, 75093
Sponsors and Collaborators
Apatech, Inc.
Investigators
Study Director: Melanie Marshall VP of Clinical Operations
  More Information

No publications provided

Responsible Party: Melanie Marshall, Director Clinical Operations, Baxter Bioscience/Apatech
ClinicalTrials.gov Identifier: NCT00974623     History of Changes
Other Study ID Numbers: APPROACH-001
Study First Received: September 8, 2009
Last Updated: May 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Apatech, Inc.:
Bone growth substitute
Autograft
Allograft
Spine fusion

Additional relevant MeSH terms:
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
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Hernia
Pathological Conditions, Anatomical
Back Pain
Pain
Neurologic Manifestations
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012