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| 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 |
| 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Trai Curtis | 972-635-7440 | therasa_curtis@baxter.com |
| 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 | |
| Study Director: | Melanie Marshall | VP of Clinical Operations |
More Information
| 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 |
|
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 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 |