Trials / Withdrawn
WithdrawnNCT05944081
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
Multicenter, Not Randomised, Non-interventional, Postmarket Clinical Follow-Up (PMCF) Study on the Performance / Safety of Arcadius XP L® Interbody Fusion Device
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Aesculap AG · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Chronic Low-back Pain
- Degenerative Disc Disease
- Spondylolysis Lumbar
- Postdiscectomy Syndrome
- Posttraumatic Instability
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ArcadiusXP 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. |
Timeline
- Start date
- 2024-03-15
- Primary completion
- 2025-08-31
- Completion
- 2025-12-12
- First posted
- 2023-07-13
- Last updated
- 2025-09-05
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT05944081. Inclusion in this directory is not an endorsement.