ArcadiusXP L Post Market Clinical Follow-Up | NCT01895426

Studies
ArcadiusXP L Post Market Clinical Follow-Up

NCT01895426

Sponsor

Aesculap AG

Status

Completed

Last Update Posted

Mar 22, 2017Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Degenerative Disc Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Jul 5, 2013

First Submission Date that Met QC Criteria

Jul 9, 2013

First Posted Date

Jul 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2017

Last Update Posted Date

Mar 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

adult patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Douglas Klassen, MD (PY)	St. Bonifatius Hospital Lingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sana Kliniken Sommerfeld		Kremmen		16766	Germany
St. Bonifatius Hospital Lingen

Condition Browse Module

MeSH Terms

ID	Term
D055959	Intervertebral Disc Degeneration

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided