ArcadiusXP L Post Market Clinical Follow-Up

Aesculap AG32 enrolled

Overview

The purpose of this study is to collect clinical and radiological mid-term (2 years) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 32 patients.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Disc Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * all indications as given by the instructions for use * Patients with persisting lumbosacral and pseudo-radicular pain scheduled for monosegmental lumbar interbody fusion from L4 to S1 * Age 18 - 60 * at least 6 months of unsuccessful treatment including conservative measures * Non-sequestrated and subligamentous prolapse Exclusion Criteria: * all contraindications, which are listed in the instructions for use. * existing pregnancy, planned or occurring during study period * patients with a higher degree of segmental degeneration in other than the segment to be operated * body- mass-index (BMI) \> 30 * Systemic or local infection * Increased risk of osteoporosis according to assessment by the SCORE evaluation * Bone metabolism disorders * Chemotherapy or radiotherapy (ongoing or planned) * Participation in another clinical trial * Scheduled for spinal litigation * Other serious conditions that hinder the participation in the study * Nanogel® filling of the cage, prior to implantation was not done

Locations (2)

Sana Kliniken Sommerfeld

Kremmen, Germany

St. Bonifatius Hospital Lingen

Lingen, Germany

Outcomes

Primary Outcomes

ODI (2y) - ODI(preop)

Difference between Oswestry Disability Index (ODI) at 2 years and preoperative ODI

Time frame: 2 years

Secondary Outcomes

Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels

Angle difference in flexion and extension radiographs at each timepoint; analysis of AP and ML x-rays regarding changes in bone density (identification of bone bridges): CT/MRT are considered when available; consideration of pot. radiolucencies around the

Time frame: 2 years

Overall success

ODI at each timepoint

Time frame: 2 years

Overall success

* Improvement of at least 15 points in the Oswestry Disability Index score compared to the baseline score; * No device failures requiring revision, reoperation, or removal; * Absence of major complications, defined as major vessel injury or major neurological deterioration (e.g., nerve root injury); * Maintenance or improvement in neurological status vs. baseline, with no permanent neurological deficits compared to baseline status.

Time frame: 2 years

Pain (back and leg)

Pain levels (back and leg) as measured via Visual Analogue scale (VAS) at each timepoint

Time frame: 2 years

Adverse events

Time frame: 2 years

Patient satisfaction

"Would you have the Operation again?"

Time frame: 2 years

Data from ClinicalTrials.gov

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