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Bone Graft Materials Observational Registry (APPROACH-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00974623
Recruitment Status : Terminated (Parent sponsor company (Baxter Healthcare) company cut funding)
First Posted : September 10, 2009
Last Update Posted : April 5, 2017
Apatech, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief Summary:
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 or disease Intervention/treatment
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

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Study Type : Observational
Actual Enrollment : 329 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Group/Cohort Intervention/treatment
Spinal Fusion
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
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

Primary Outcome Measures :
  1. Evidence of successful radiographic fusion [ Time Frame: 6 months, 12 months & 24 months ]

Secondary Outcome Measures :
  1. Maintenance or improvement in neurological status, as compared to baseline scores [ Time Frame: 6 months 12 months & 24 months ]
  2. Improvement of pain/function in comparison to pre-operative QOL scores [ Time Frame: 6 months, 12 months & 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00974623

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United States, California
San Francisco, California, United States, 94143
United States, Georgia
St. Joseph's Hospital - Resurgeons Orthopedics
Atlanta, Georgia, United States, 30342
Carrollton Orthopedics
Carrollton, Georgia, United States, 30117
United States, Kentucky
Bluegrass Orthopedics & Hand Care Research
Lexington, Kentucky, United States, 40509
United States, Massachusetts
Arthritis & Joint Center - U. Mass. Memorial
Worcester, Massachusetts, United States, 01605
United States, Michigan
Southfield, Michigan, United States, 48072
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
United States, Montana
Montana Neuroscience Institute Foundation
Missoula, Montana, United States, 59802
United States, Nevada
Physicians Research Options Spine Center
Las Vegas, Nevada, United States, 89144
United States, New York
Syracuse Orthopedic Specialists
Syracuse, New York, United States, 13215
United States, Tennessee
Neurosurgical Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Brain & Spine of Texas
Plano, Texas, United States, 75093
Buda Health Center
Budapest, Hungary
Isala Klinieken
Groot Wezenland, Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Baxter Healthcare Corporation
Apatech, Inc.
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Study Director: Huub Kreuwel, Ph.D Director of Medical Affairs
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Responsible Party: Baxter Healthcare Corporation Identifier: NCT00974623    
Other Study ID Numbers: APPROACH-001
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Baxter Healthcare Corporation:
Bone growth substitute
Spine fusion
Additional relevant MeSH terms:
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Spinal Cord Neoplasms
Spinal Stenosis
Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Spinal Cord Diseases
Failed Back Surgery Syndrome
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Back Pain
Neurologic Manifestations
Pathological Conditions, Anatomical
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site