The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
Study Type
OBSERVATIONAL
The ArcadiusXP L® Interbody Fusion System is a stand-alone device intended to be used with four bone screws if no supplement fixation is used to stabilize the lumbar spine through an anterior approach. Levels of anterior lumbar interbody fusion for the indications listed in the instructions for use are from L2-S1.
Schelztor-Klinik Esslingen
Esslingen am Neckar, Baden-Wurttemberg, Germany
Medius Klinik Nürtingen
Nürtingen, Baden-Wurttemberg, Germany
Rems-Murr-Klinik Schorndorf
Schorndorf, Baden-Wurttemberg, Germany
Functional outcome after minimum 1 year postoperatively
The Oswestry Disability Index (ODI) 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.
Time frame: at follow-up approximately 1 year postoperatively
Pain assessment
Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain". Pain will be recorded at minimum 12 months postoperatively, if available in the preoperative clinical routine data, it will also be recorded in the study.
Time frame: at follow-up approximately 1 year postoperatively
Development Quality of life (EQ-5D-5L)
"EQ-5D-5L" is a standardized 5-dimension 5-level measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. In order to analyze the quality of life of the patients, the EQ-5D-5L is used. The score is self-completed by the patient and will therefore be used in German.
Time frame: at follow-up approximately 1 year postoperatively
Radiological Outcome: Bone fusion
After Interbody Fusion surgery fusion of the treated segment is aspired. Thus, the implant design shall allow on-/ingrowth to/into the material. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate.
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Time frame: at follow-up approximately 1 year postoperatively
Rate of (Serious) adverse events
Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications AEs and SAEs deemed related to the investigational device are recorded.
Time frame: at follow-up approximately 1 year postoperatively