Bone Graft Materials Observational Registry (APPROACH-001)

This study has been terminated.
(Parent sponsor company (Baxter Healthcare) company cut funding)
Sponsor:
Information provided by (Responsible Party):
Apatech, Inc.
ClinicalTrials.gov Identifier:
NCT00974623
First received: September 8, 2009
Last updated: November 12, 2013
Last verified: November 2013
  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 ]

Enrollment: 329
Study Start Date: September 2009
Study Completion Date: November 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  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
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, see Learn About Clinical Studies.

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

Locations
United States, California
UCSF
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
PRESSD
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
Hungary
Buda Health Center
Budapest, Hungary
Netherlands
Isala Klinieken
Groot Wezenland, Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Apatech, Inc.
Investigators
Study Director: Huub Kreuwel, Ph.D Director of Medical Affairs
  More Information

No publications provided

Responsible Party: Apatech, Inc.
ClinicalTrials.gov Identifier: NCT00974623     History of Changes
Other Study ID Numbers: APPROACH-001
Study First Received: September 8, 2009
Last Updated: November 12, 2013
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 July 23, 2014