Multicenter, Not Randomised, Non-interventional, Postmarket Clinical Follow-Up (PMCF) Study on the Performance / Safety of Arcadius XP L® Interbody Fusion Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Low-back Pain
- Sponsor
- Aesculap AG
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Functional outcome after minimum 1 year postoperatively
- Status
- Withdrawn
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
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:
Outcomes
Primary Outcomes
Functional outcome after minimum 1 year postoperatively
Time Frame: 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 Outcomes
- Radiological Outcome: Bone fusion(at follow-up approximately 1 year postoperatively)
- Rate of (Serious) adverse events(at follow-up approximately 1 year postoperatively)
- Pain assessment(at follow-up approximately 1 year postoperatively)
- Development Quality of life (EQ-5D-5L)(at follow-up approximately 1 year postoperatively)