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Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement (POLYTITAN)

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ClinicalTrials.gov Identifier: NCT02524587
Recruitment Status : Active, not recruiting
First Posted : August 17, 2015
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.

Condition or disease Intervention/treatment Phase
Total Hip Replacement Device: standard polyethylene acetabular irradiated at 3 Mrad Other: radio stereometric analysis (RSA) of the acetabular Device: acetabular polyethylene vitamys® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : January 2010
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Active Comparator: acetabular polyethylene vitamys®
acetabular polyethylene vitamys®
Other: radio stereometric analysis (RSA) of the acetabular
Device: acetabular polyethylene vitamys®
Active Comparator: standard polyethylene acetabular irradiated at 3 Mrad
standard polyethylene acetabular irradiated at 3 Mrad
Device: standard polyethylene acetabular irradiated at 3 Mrad
Other: radio stereometric analysis (RSA) of the acetabular



Primary Outcome Measures :
  1. penetration of the metal femoral head in acetabular [ Time Frame: 2 years ]
    head penetration in milimeters



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged men and women 18 to 75 years
  • with a primary or secondary osteoarthritis or osteonecrosis
  • having a functional disorder requiring the installation of a total hip prosthesis of primary

Exclusion Criteria:

  • patients aged 76 years or more
  • pregnant or desiring to be for the duration of the study
  • minors or adults protected
  • repeated hip replacement
  • cephalic prosthesis recovery or intermediate
  • repeated cupules
  • primary or secondary malignant tumor of the hip

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524587


Locations
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France
Département d'orthopédie - traumatologie, CHU de Caen
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02524587     History of Changes
Other Study ID Numbers: 09-113
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018