ArcadiusXP L Post Market Clinical Follow-Up (ArcadiusXPLPMS)

March 21, 2017 updated by: Aesculap AG

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kremmen, Germany, 16766
        • Sana Kliniken Sommerfeld
      • Lingen, Germany, 49808
        • St. Bonifatius Hospital Lingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Peter Douglas Klassen, MD (PY), St. Bonifatius Hospital Lingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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