The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Dynesys Spinal System will be used for all subjects
Neurological Surgery of Southern Ill
Belleville, Illinois, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Pine Heights Medical Center
Baltimore, Maryland, United States
Fusion Rates
Fusion was defined by meeting three criteria: * rotation \< 5° between motion segments on flexion-extension radiographs * translation \< 3 mm between motion segments on flexion-extension radiographs * presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control.
Time frame: 24 months post surgery date
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NYU - Center for Musculoskeletal Care
New York, New York, United States
Riverhills Healthcare, Inc
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
OrthopaediCare
Willow Grove, Pennsylvania, United States
Danville Orthopedics and Spine
Danville, Virginia, United States