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

NCT ID: NCT00722982

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2015-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Coxarthrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

2

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* coxarthrosis

Exclusion Criteria

* age over 80
* major medial condition such as renal failure, chronic obstructive lung disease heart failure etc
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ringerike hospital HF, Hønefoss Norway

UNKNOWN

Sponsor Role collaborator

Ortomedic AS, Lysaker Norway

UNKNOWN

Sponsor Role collaborator

Helse Sor-Ost

OTHER_GOV

Sponsor Role collaborator

Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Nordsletten, Professor

Role: STUDY_CHAIR

Ullevaal University Hospital

Locations

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Oslo University Hospital

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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C-stem AMT

Identifier Type: -

Identifier Source: org_study_id