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Sponsored by: |
Medtronic Spine, Biologics & Navigation |
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Information provided by: | Medtronic Spine, Biologics & Navigation |
ClinicalTrials.gov Identifier: | NCT00635934 |
The purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary clinical endpoint.
Condition | Intervention | Phase |
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Spinal Diseases |
Device: A-MAV™ disc |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Non-Randomized Pilot Clinical Investigation of the A-MAV™ Anterior Motion Segment Replacement in Patients With Lumbar Degenerative Disc Disease |
Enrollment: | 53 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A-MAV™disc: Experimental |
Device: A-MAV™ disc
The A-MAV™ device is a spinal arthroplasy system intended to replace a damaged spinal disc. It is inserted using an anterior surgical approach and aims to reduce low back pain and maintain disc height at the affected level.
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For this clinical trial, there is only one treatment group- patients receiving the A-MAV™ Anterior Motion Segment Replacement via an anterior surgical approach in the lumbar region of the spine from L4-S1.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Has back and/or radicular pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies with one or more of the following factors:
Exclusion Criteria:
Meets any of the following criteria: Previous diagnosis of osteoporosis, osteopenia, or osteomalacia; postmenopausal Non-Black female over 60 yrs of age and weighs less than 140 pounds; postmenopausal female that has sustained a non-traumatic hip, spine or wrist fracture; male over age 60 that has sustained a non-traumatic hip or spine fracture. If Yes to any of these, a DEXA scan is required. If level of BMD is -3.5 or lower or
United States, Georgia | |
Hughston Clinic | |
Columbus, Georgia, United States, 31908 | |
United States, Missouri | |
Orthopedic Center of St. Louis | |
Chesterfield, Missouri, United States, 63017 | |
United States, Texas | |
Central Texas Spine | |
Austin, Texas, United States, 78731 |
Responsible Party: | Clinical Department ( Ed Hord / Sr. Manager, Clinical Affairs ) |
Study ID Numbers: | G040135 |
Study First Received: | March 7, 2008 |
Last Updated: | March 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00635934 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lumbar Degenerative Disc Disease at One Level from L4-S1 |
Spinal Diseases Musculoskeletal Diseases Benzocaine Bone Diseases |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |