ArcadiusXP L Post Market Clinical Follow-Up

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-02-28

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.

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Detailed Description

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Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No