Chronic Low-back Pain, Degenerative Disc Disease, Postdiscectomy Syndrome, Posttraumatic Instability, Spondylolysis Lumbar
Conditions
Keywords
stand-alone cage, lumbar spine, interbody fusion device
Brief summary
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.
Interventions
DEVICEArcadiusXP L® Interbody Fusion System
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.
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* all patients who received a Arcadius XP L® interbody fusion device between 2016 until approx. January 2021 (minimum Follow-up is one year) in the study center * all indications as given by the instructions for use: degenerative disc disease (DDD), Instability, Spondylolisthesis up to grade 1, Post-discectomy syndrome, Post-traumatic instability * Written informed consent for the documentation of clinical and radiological results
Exclusion criteria
* Patient is not willing or able to participate at the follow-up examination * Patients living outside a radius of 100 km around the study center * all contraindications as given by the instructions for use:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome after minimum 1 year postoperatively | at follow-up approximately 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | at follow-up approximately 1 year postoperatively | 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. |
| Development Quality of life (EQ-5D-5L) | at follow-up approximately 1 year postoperatively | 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. |
| Radiological Outcome: Bone fusion | at follow-up approximately 1 year postoperatively | 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. |
| Rate of (Serious) adverse events | at follow-up approximately 1 year postoperatively | 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. |
Countries
Germany
Outcome results
None listed