Overview

This trial is active, not recruiting.

Condition coxarthrosis
Sponsor Ullevaal University Hospital
Collaborator Ringerike hospital HF, Hønefoss Norway
Start date July 2008
End date May 2012
Trial size 70 participants
Trial identifier NCT00722982, C-stem AMT

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm

Primary Outcomes

Measure
Migration of femur- and acetabular prosthesis measured by RSA
time frame: 2008-2012

Secondary Outcomes

Measure
Periprosthetic osteolysis of proximal femur
time frame: 2008-2012

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

Inclusion Criteria: - coxarthrosis Exclusion Criteria: - age over 80 - major medial condition such as renal failure, chronic obstructive lung disease heart failure etc

Additional Information

Official title Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Oslo University Hospital.