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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01443975
Other study ID # N-20110043
Secondary ID
Status Completed
Phase N/A
First received September 29, 2011
Last updated March 28, 2014
Start date September 2011
Est. completion date June 2013

Study information

Verified date March 2014
Source Northern Orthopaedic Division, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

The purpose of this study is to clinically evaluate the use of the x-pander device.


Description:

Clinical evaluation on the use of the x-pander device during THA-surgery


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis for hip osteoarthrosis

Exclusion Criteria:

- Previous surgery of the actual hip

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
x-pander
Measurement of the size and quality of the bony acetabulum before mounting the artificial hip socket.

Locations

Country Name City State
Denmark Ortopaedic Clinic Farsoe Hospital, Aalborg University Hospital
Denmark Ortopaedic Clinic Frederikshavn Hospital, Aalborg University Hospital

Sponsors (2)

Lead Sponsor Collaborator
Northern Orthopaedic Division, Denmark Company Medichanical Engineering

Country where clinical trial is conducted

Denmark, 

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