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

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ClinicalTrials.gov Identifier: NCT00722982
Recruitment Status : Unknown
Verified November 2014 by Oslo University Hospital ( Ullevaal University Hospital ).
Recruitment status was:  Active, not recruiting
First Posted : July 28, 2008
Last Update Posted : November 24, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Condition or disease

Study Design

Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty
Study Start Date : July 2008
Primary Completion Date : May 2012
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Migration of femur- and acetabular prosthesis measured by RSA [ Time Frame: 2008-2012 ]

Secondary Outcome Measures :
  1. Periprosthetic osteolysis of proximal femur [ Time Frame: 2008-2012 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • coxarthrosis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722982

Oslo University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Ringerike hospital HF, Hønefoss Norway
Ortomedic AS, Lysaker Norway
Helse Sor-Ost
Study Chair: Lars Nordsletten, Professor Ullevaal University Hospital
More Information

Responsible Party: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00722982     History of Changes
Other Study ID Numbers: C-stem AMT
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: November 2014

Keywords provided by Oslo University Hospital ( Ullevaal University Hospital ):
C-stem AMT

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases