Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-12-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Low-back Pain Degenerative Disc Disease Spondylolysis Lumbar Postdiscectomy Syndrome Posttraumatic Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arcadius XP L®

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

ArcadiusXP L® Interbody Fusion System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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:

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No