This postmarket surveillance study is being conducted to evaluate the TRANSITION Stabilization System as an adjunct to fusion in the treatment of acute or chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization System. The data from this postmarket surveillance study will be provided to FDA in accordance with the 522 order.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States
Fusion Rates
The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.
Time frame: 24 months
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