Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement
POLYTITAN
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
August 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedSeptember 11, 2018
September 1, 2018
6.8 years
August 6, 2015
September 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
penetration of the metal femoral head in acetabular
head penetration in milimeters
2 years
Study Arms (2)
acetabular polyethylene vitamys®
ACTIVE COMPARATORacetabular polyethylene vitamys®
standard polyethylene acetabular irradiated at 3 Mrad
ACTIVE COMPARATORstandard polyethylene acetabular irradiated at 3 Mrad
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Département d'orthopédie - traumatologie, CHU de Caen
Caen, 14000, France
Related Publications (1)
Rochcongar G, Remazeilles M, Bourroux E, Dunet J, Chapus V, Feron M, Praz C, Buia G, Hulet C. Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial. Acta Orthop. 2021 Apr;92(2):151-155. doi: 10.1080/17453674.2020.1852785. Epub 2020 Dec 2.
PMID: 33263447DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2015
First Posted
August 17, 2015
Study Start
January 1, 2010
Primary Completion
November 1, 2016
Study Completion
November 1, 2022
Last Updated
September 11, 2018
Record last verified: 2018-09