The purpose of this open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the SpineLink® system.
This will be an open, prospective, multi-center outcome study. This study will be conducted at up to ten centers, each of which will enroll approximately 20 patients. A maximum of 200 patients will be enrolled. This patient sample size will allow statistical comparison to historical literature and allow an inter-center comparison of outcome. Enrollment into the study may include all patients who have lumbar spinal fusion performed. All spinal fusion surgery will be performed using the EBI SpineLink® system.
Study Type
OBSERVATIONAL
Enrollment
202
Spine plate system for lumbar spinal fusions
Alvarado Orthopedic Clinic
San Diego, California, United States
Rogozinski Orthopedic Clinic
Jacksonville, Florida, United States
Percentage of successful fusions achieved
AP radiographs will be evaluated for the evidence of bridging virgin trabecular bone across the fusion mass. In order for a patient to be considered fused, A/P radiographs must show evidence of bridging virgin trabecular bone across the fusion mass.
Time frame: 24 Months
Neurologic Assessment
Maintenance or Improvement
Time frame: 24 Months
Radiographic Fusion Grade
Radiographic fusion grade will be assessed at each follow up, as defined by Dawson et al. 8, as follows: A0 = Pseudarthrosis A1 = Unilateral Pseudarthrosis A2 = Insufficient Unilateral Bone Mass A3 = Contiguous Fusion without Hypertrophy A4 = Solid Fusion with Hypertrophy of Fusion Mass
Time frame: 24 Months
SF-36 Health Survey
Health Survey
Time frame: 24 Months
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