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Sponsored by: |
Medtronic Spine, Biologics & Navigation |
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Information provided by: | Medtronic Spine, Biologics & Navigation |
ClinicalTrials.gov Identifier: | NCT00437190 |
The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc in treating single-level degenerative disc disease of the cervical spine.
Condition | Intervention | Phase |
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Cervical Degenerative Disc Disease |
Device: BRYAN(R) Cervical Disc Device: Anterior discectomy and fusion with anterior plate fixation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
The indication studied was degenerative disc disease (DDD) at a single level between C3 and C7 for any combination of disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.
The following additional inclusion criteria had to be present:
Exclusion Criteria:
Subjects were excluded if they had any of the following:
Any of the following at the treated level:
Study ID Numbers: | BRYAN(R) Cervical Disc IDE |
Study First Received: | February 16, 2007 |
Last Updated: | February 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00437190 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cervical Disc Replacement |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |