Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-02

Study Completion Date

2022-12-31

Brief Summary

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Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.

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Detailed Description

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Conditions

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Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Metal-on-conventional polyethylene

Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a CoCr prosthetic femoral head and an acetabular liner made of intermedially cross-linked polyethylene polyethylene (Duration, Stryker, Mahwah, NJ, US).

Group Type ACTIVE_COMPARATOR

Metal-on-polyethylene uncemented total hip arthroplasty

Intervention Type DEVICE

Ceramic-on-ceramic

Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a prosthetic femoral head and an acetabular liner made of alumina ceramic (Biolox Forte, Ceramtec, Plochingen, Germany).

Group Type EXPERIMENTAL