Clinical Evaluation on the Use of the X-pander Device (X-Pander)

March 28, 2014 updated by: Northern Orthopaedic Division, Denmark
The purpose of this study is to clinically evaluate the use of the x-pander device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

100

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

  • Denmark
      • Farsoe Hospital, Aalborg University Hospital, Denmark, 9640
        • Ortopaedic Clinic
      • Frederikshavn Hospital, Aalborg University Hospital, Denmark, 9900
        • Ortopaedic Clinic

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients for primary THA

Description

Inclusion Criteria:

  • Clinical diagnosis for hip osteoarthrosis

Exclusion Criteria:

  • Previous surgery of the actual hip

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
Measurement with x-pander in acetabulum prior to inserting the artificial hip socket.
Procedure: x-pander
Measurement of the size and quality of the bony acetabulum before mounting the artificial hip socket.

Collaborators and Investigators

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

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Company Medichanical Engineering

Investigators

  • Principal Investigator: Mogens B. Laursen, MD, PhD, Orthopaedic Surgery Research Unit, Aalborg Hospital, Denmark

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

September 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 31, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20110043

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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