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NCT00722982 Clinical Trial

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

Coxarthrosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00722982
Other study ID # C-stem AMT
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 25, 2008
Last updated November 21, 2014
Start date July 2008
Est. completion date July 2015

Study information
Verified date November 2014
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Directorate of Health
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date July 2015
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- coxarthrosis

Exclusion Criteria:

- age over 80

- major medial condition such as renal failure, chronic obstructive lung disease heart failure etc

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (4)
Lead Sponsor Collaborator
Ullevaal University Hospital Helse Sor-Ost, Ortomedic AS, Lysaker Norway, Ringerike hospital HF, Hønefoss Norway

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Migration of femur- and acetabular prosthesis measured by RSA 2008-2012 No
Secondary Periprosthetic osteolysis of proximal femur 2008-2012 No
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