WithdrawnNot Applicable

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

Stopped: Limited patient willingness and clinic capacity hindered follow-up data collection for the registry study, as appointments required extra resources beyond routine care.

Germany0Started 2024-03-15

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:

What they're measuring

Functional outcome after minimum 1 year postoperatively

Timeframe: at follow-up approximately 1 year postoperatively

Trial details

NCT IDNCT05944081

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-08-31

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