Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty

November 21, 2014 updated by: Ullevaal University Hospital

Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis

In Norway it is annually performed approximately 600 primary and 100 revisions THA. Osteolysis around the prosthesis is one of the major difficulties while performing revision surgery. C-stem is a triple tapered cemented prosthesis designed to increase the stress and strain of proximal femur and thereby decreasing osteolysis. We are planning til include 70 patients and randomize to C-stem AMT or Exeter prosthesis. Both prosthesis will be combined with previously non documented "Marathon" acetabular prosthesis.

The result will be followed clinically and with RSA and DXA. Soft endpoint after 2 years

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

70

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

  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital

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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

70 patients admitted to orthopedic clinic Ringerike hospital for coxarthrosis are planned to be included in stydy. The all should agree in a written form to participate in study. They are randomized to be operated THA with Exeter- or C-stem AMT femur prostesis. Marathon acetabular prosthesis will be used for all patients included.

Description

Inclusion Criteria:

  • coxarthrosis

Exclusion Criteria:

  • age over 80
  • major medial condition such as renal failure, chronic obstructive lung disease heart failure etc

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-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Migration of femur- and acetabular prosthesis measured by RSA
Time Frame: 2008-2012
2008-2012

Secondary Outcome Measures

Outcome Measure
Time Frame
Periprosthetic osteolysis of proximal femur
Time Frame: 2008-2012
2008-2012

Collaborators and Investigators

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

Sponsor

Ullevaal University Hospital

Collaborators

Helse Sor-Ost
Ringerike hospital HF, Hønefoss Norway
Ortomedic AS, Lysaker Norway

Investigators

  • Study Chair: Lars Nordsletten, Professor, Ullevaal University Hospital

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

July 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 28, 2008

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 21, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-stem AMT

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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