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Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device | Clinical Trials | Clareo Health

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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

NCT05944081•Aesculap AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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:

Locations (3)

Schelztor-Klinik Esslingen

Esslingen am Neckar, Baden-Wurttemberg, Germany

Medius Klinik Nürtingen

Nürtingen, Baden-Wurttemberg, Germany

Rems-Murr-Klinik Schorndorf

Schorndorf, Baden-Wurttemberg, Germany

Key Dates

Start Date

March 15, 2024

Primary Completion Date

August 31, 2025

Completion Date

December 12, 2025

Last Updated

September 5, 2025

Conditions

Chronic Low-back PainDegenerative Disc DiseaseSpondylolysis LumbarPostdiscectomy SyndromePosttraumatic Instability

Interventions

ArcadiusXP L® Interbody Fusion System

DEVICE

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

NCT07254806

Degenerative Disc Disease

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RECRUITINGNA

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

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Degenerative Disc DiseaseChronic Low-back Pain

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Real World Data Collection on the Synergy Disc