Is There Increased Polyethylene Wear and Increased Periprosthetic Bone Loss in Femur in Reverse Hybrid Technique Compared With Conventional Cemented Technique in Total Hip Replacement?

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00526539
First received: September 6, 2007
Last updated: July 3, 2011
Last verified: September 2007
  Purpose

Total hip replacement is a very cost effective procedure to enhance life quality in a group of patients. In the period 2000-2004 7-8000 procedures were preformed, 13% were revisions (1). Historically, many different principles have been used from the first resurfacings to cemented and uncemented total hip replacements as we know them today. In 2000, 28 different femoral stems and 26 different acetabular components were in regular use in Norway. There are several well-documented cemented acetabular components, but no such uncemented cup. On the femoral side there are several well-documented stems both cemented and uncemented. (2).

From the late 1990`s a reverse hybrid (uncemented stem and cemented cup) is being more frequently used. In 2004 a total of 276 reverse hybrid hips were done and the trend is increasing. (1). This technique is solely based on experience and the fact that one combines the better of two principles (cemented and uncemented). There is no scientific evidence that this technique is as good or better than a cemented THR.

One of the potential problems with hydroxyapatite coated components is that it is suspected that it may increase wear due to the particle theory. (3,4). There are no prospective randomised controlled RSA and DXA studies that conclude on this matter. This is such a study and our hypothesis is that there is no difference in wear or osteolysis between the methods.


Condition Intervention
Osteoarthritis
Other: Total hip replacement, Spectron and Taperloc

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Osteoarthritis
  • Indication for THR

Exclusion Criteria:

  • Significant anatomical abnormalities
  • Rheumatoid artheritis, dysplasia, fracture sequela
  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: NCT00526539

Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Chair: Lars Nordsletten, professor, MD, Ph.D Ullevål University Hospital, N-0407 Oslo
Principal Investigator: Einar Lindalen, MD Lovisenberg Hospital, N- 0440 Oslo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00526539     History of Changes
Other Study ID Numbers: Reverse hybrid vs cemented THR
Study First Received: September 6, 2007
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
THR
reversed hybrid
wear

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

ClinicalTrials.gov processed this record on July 24, 2014