ArcadiusXP L Post Market Clinical Follow-Up

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01895426

Acronym

ArcadiusXPLPMS

Enrollment

Registered

2013-07-10

Start date

2013-04-30

Completion date

2017-02-28

Last updated

2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Overall success	2 years	ODI at each timepoint
Pain (back and leg)	2 years	Pain levels (back and leg) as measured via Visual Analogue scale (VAS) at each timepoint
Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels	2 years	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
Patient satisfaction	2 years	Would you have the Operation again?
Concomitant pain medication	2 years	Documentation of drug related medication
Adverse events	2 years	—

Countries

Germany

Outcome results