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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ringerike hospital HF, Hønefoss Norway
Ortomedic AS, Lysaker Norway
Helse Sor-Ost
Information provided by (Responsible Party):
Oslo University Hospital ( Ullevaal University Hospital )
ClinicalTrials.gov Identifier:
NCT00722982
First received: July 25, 2008
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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
Coxarthrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Migration of femur- and acetabular prosthesis measured by RSA [ Time Frame: 2008-2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Periprosthetic osteolysis of proximal femur [ Time Frame: 2008-2012 ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: July 2008
Estimated Study Completion Date: July 2015
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722982

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

No publications provided

Responsible Party: Oslo University Hospital ( Ullevaal University Hospital )
ClinicalTrials.gov Identifier: NCT00722982     History of Changes
Other Study ID Numbers: C-stem AMT
Study First Received: July 25, 2008
Last Updated: November 21, 2012
Health Authority: Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
coxarthrosis
hip
RSA
DXA
C-stem AMT
Marathon

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

ClinicalTrials.gov processed this record on July 28, 2014