Wear, bone density, functional outcome and survival in vitamin E-incorporated polyethylene cups in reversed hybrid total hip arthroplasty: design of a randomized controlled trialReport as inadecuate




Wear, bone density, functional outcome and survival in vitamin E-incorporated polyethylene cups in reversed hybrid total hip arthroplasty: design of a randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

BMC Musculoskeletal Disorders

, 13:178

First Online: 20 September 2012Received: 28 February 2012Accepted: 19 September 2012

Abstract

BackgroundAseptic loosening of total hip arthroplasties is generally caused by periprosthetic bone resorption due to tissue reactions on polyethylene wear particles. In vitro testing of polyethylene cups incorporated with vitamin E shows increased wear resistance. The objective of this study is to compare vitamin E-stabilized highly cross-linked polyethylene with conventional cross-linked polyethylene in -reversed hybrid- total hip arthroplasties cemented all-polyethylene cups combined with uncemented femoral stems. We hypothesize that the adjunction of vitamin E leads to a decrease in polyethylene wear in the long-term. We also expect changes in bone mineral density, less osteolysis, equal functional scores and increased implant survival in polyethylene cemented cups incorporated with vitamin E in the long-term.

DesignA double-blinded randomized controlled trial will be conducted. Patients to be included are aged under 70, suffer from non-inflammatory degenerative joint disease of the hip and are scheduled for a primary total hip arthroplasty. The study group will receive a reversed hybrid total hip arthroplasty with a vitamin E-stabilized highly cross-linked polyethylene cemented cup. The control group will receive a reversed hybrid total hip arthroplasty with a conventional cross-linked polyethylene cemented cup. Radiological follow-up will be assessed at 6 weeks and at 1, 3, 5, 7 and 10 years postoperatively, to determine polyethylene wear and osteolysis. Patient-reported functional status HOOS, physician-reported functional status Harris Hip Score and patients’ physical activity behavior SQUASH will also be assessed at these intervals. Acetabular bone mineral density will be assessed by dual energy X-ray absorptiometry DEXA at 6 weeks and at 1 year and 2 years postoperatively. Implant survival will be determined at 10 years postoperatively.

DiscussionIn vitro results of vitamin E-stabilized polyethylene are promising, showing increased wear resistance. However, controlled clinical follow-up data are not available at this moment.

This randomized controlled trial has been designed to determine wear, bone mineral density, functional outcome and survival in reversed hybrid total hip arthroplasty comparing cemented vitamin E-stabilized highly cross-linked polyethylene cups with cemented conventional cross-linked polyethylene cups.

Trial registrationDutch Trial Registry NTR3049

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Author: Hugo C van der Veen - Inge van den Akker-Scheek - Sjoerd K Bulstra - Jos JAM van Raay

Source: https://link.springer.com/







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