ArcadiusXP L Post Market Clinical Follow-Up

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Follow-up of the ArcadiusXP L Stand Alone Intervertebral Body Fusion Device

Conditions
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Degenerative Disc Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODI (2y) - ODI(preop) | Difference between Oswestry Disability Index (ODI) at 2 years and preoperative ODI | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 
| Overall success | ODI at each timepoint | 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. | 2 years | 
| Pain (back and leg) | Pain levels (back and leg) as measured via Visual Analogue scale (VAS) at each timepoint | 2 years | 
| Adverse events |  | 2 years | 
| Patient satisfaction | Would you have the Operation again? | 2 years | 
| Concomitant pain medication | Documentation of drug related medication | 2 years |