Disk Herniated LumbarDisc Disease DegenerativeSpondylolisthesis
Investigational drug(s) / intervention(s)
Transforaminal Lumbar Interbody Fusion
Transforaminal Lumbar Interbody Fusion: Interbody Fusion means the operative immobilization or ankylosis of two or more vertebrae by fusion of the vertebral bodies with a short bone graft or often with diskectomy or laminectomy. (From Blauvelt and Nelson, A Manual of Orthopaedic Terminology, 5th ed, p236; Dorland, 28th ed
Study summary
Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion
Eligibility
Sex
ALL
Min age
18 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria:
* Indication for one, two or three-segment lumbar interbody fusion according to Instructions for use
* Written informed consent for the documentation of clinical and radiological results
* Willingness and mental ability to participate at the follow-up examinations
Exclusion Criteria:
* Patient is not willing or able to participate at the follow-up examination
* Patient age \< 18 years and \>80 years
* Patient is pregnant
* Previous instrumented lumbar spine surgery
Primary outcome measure(s)
Clinical outcome measured with the Oswestry Disability Index — 1 year postoperatively The Oswestry Disability Index is designed to measure back-specific disability. The questionnaire is self-administered and has 10 items concerning pain and activities of daily living including personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. It is a self-administered questionnaire Each section is scored on a 0-5 scale, 5 is for maximum disability. The index is calculated by dividing the total score by the total possible score, which is multiplied by 100 and expressed as a percentage. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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