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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 growth substitute, autograft or allograft |
| Study Type: | Observational |
| Study Design: | Cohort, 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: | April 2012 |
| Estimated Primary Completion Date: | October 2010 (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 growth substitute, autograft or allograft
spine fusion surgery utilizing any commercially available bone growth substitute(s), autograft or allograft
|
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 | trai.curtis@apatech.com |
| United States, New York | |
| Syracuse Orthopedic Specialists | Recruiting |
| Syracuse, New York, United States, 13215 | |
| United States, Tennessee | |
| Neurosurgical Associates | Not yet recruiting |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Brain & Spine of Texas | Not yet recruiting |
| Plano, Texas, United States, 75093 | |
| Study Director: | Melanie Marshall | VP of Clinical Operations |
More Information
| Responsible Party: | Apatech, Inc. ( Melanie Marshall, VP Clinical Operations ) |
| Study ID Numbers: | APPROACH-001 |
| Study First Received: | September 8, 2009 |
| Last Updated: | September 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00974623 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Bone growth substitute Autograft Allograft Spine fusion |
|
Spinal Diseases Disease Spinal Cord Diseases Nervous System Diseases Central Nervous System Diseases Spondylolisthesis Central Nervous System Neoplasms Bone Diseases Spinal Stenosis |
Neoplasms Pathologic Processes Neoplasms by Site Musculoskeletal Diseases Syndrome Spinal Cord Neoplasms Intervertebral Disk Displacement Nervous System Neoplasms |