Last updated on July 2019

Neurologic Disorders


Brief description of study

The purpose of this study is to collect retrospective real-world clinical data to assess the performance including efficacy and safety of CD HORIZON® LEGACY™ PEEK Rod Spinal System used as supplemental fixation for a posterior interbody fusion cage in subjects who have undergone a posterior non-cervical spinal fusion procedure for the treatment of degenerative disk disease (DDD).

Eligibility Criteria:

Inclusion
1. Subject will have been instrumented with CD HORIZON® LEGACY™ PEEK Rod Spinal System in conjunction with an interbody fusion cage in a posterior, non-cervical fixation at 1 or 2 levels for the treatment of DDD.
2. Surgery was performed between September 15, 2005 and May 01, 2015.
3. Follow-up clinical records (e.g. clinical/medical records and radiographic procedure data) are available for assessment, at a minimum, for the 12-month follow-up visit (6 months – 18 months: 181-547 days) post-surgery.
4. Subjects have available imaging (e.g. neutral lateral) of the target level(s) which allow assessment of fusion at 12-month follow-up visit (6 months – 18 months: 181-547 days) post-surgery. Baseline imaging views will also be collected, if available.
5. Subject was 21 years of age or older and skeletally mature at the time of implantation with the CD HORIZON® LEGACY™ PEEK Rod Spinal System.

Exclusion
A subject will be excluded from inclusion in this study for any of the following reasons at the time of surgery:
1. History of previous spinal fusion procedures at the index or adjacent levels.
2. Grade level > 1 of spondylolisthesis and/or retrolisthesis at the index level(s).
3. Any case using any rhBMP bone grafting products, e.g. INFUSE®/Inductos® Bone Graft (rhBMP- 2/ACS), OP-1 (rhBMP-7), etc.
4. Any case not using allograft or autograft products.

Clinical Study Identifier: TX133569

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