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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?

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total hip replacement, Spectron and Taperloc
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis focused on measuring THR, reversed hybrid, wear

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Osteoarthritis
  • Indication for THR

Exclusion Criteria:

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 6, 2007
    Last Updated
    July 3, 2011
    Sponsor
    Ullevaal University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00526539
    Brief Title
    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?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ullevaal University Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis
    Keywords
    THR, reversed hybrid, wear

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Total hip replacement, Spectron and Taperloc

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    75 Years
    Eligibility Criteria
    Inclusion Criteria: Osteoarthritis Indication for THR Exclusion Criteria: Significant anatomical abnormalities Rheumatoid artheritis, dysplasia, fracture sequela
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lars Nordsletten, professor, MD, Ph.D
    Organizational Affiliation
    Ullevål University Hospital, N-0407 Oslo
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Einar Lindalen, MD
    Organizational Affiliation
    Lovisenberg Hospital, N- 0440 Oslo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    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?

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