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

Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients

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.

Study Overview

• Status: Unknown
• Conditions: Arthroplasty Complications
• Intervention / Treatment: Device: Metal-on-polyethylene uncemented total hip arthroplasty; Device: Ceramic-on-ceramic uncemented hip arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• primary osteoarthritis
• secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)

Exclusion Criteria:

• inflammatory arthritis
• hip joint infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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).	Device: Metal-on-polyethylene uncemented total hip arthroplasty
EXPERIMENTAL: 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).	Device: Ceramic-on-ceramic uncemented hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteolysis frequency change between 7 and 15 years	Osteolysis frequency (%) measured with computed tomography,	Change between 7 to 15 years after surgery
Osteolysis size change between 7 and 15 years	Osteolysis size (cm3) measured with computed tomography	Change between 7 and 15 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Articulation wear at 7 years	Articulation wear as measured with radiostereometry, mm/year	At 7 years after surgery
Articulation wear at 15 years	Articulation wear as measured with radiostereometry, mm/year	15 years after surgery
Implant fixation at 7 years	Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry	7 years after surgery
Implant fixation at 15 years	Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry	At 15 years after surgery
Clinical function at 7 years	Harris Hip Score (0-100)	7 years after surgery
Clinical function at 15 years	Harris Hip Score (0-100)	15 years after surgery

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Stryker Nordic

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2003
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: September 30, 2018
• First Posted (ACTUAL): October 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 30, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: hip arthroplasty; biomaterials; aseptic loosening; osteolysis; Implant wear
• Other Study ID Numbers: Protesteam_ceram

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes