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

Not Applicable

• Conditions: Arthroplasty Complications
• Interventions: Device: Ceramic-on-ceramic uncemented hip arthroplasty; Device: Metal-on-polyethylene uncemented total hip arthroplasty

• Registration Number: NCT03692364
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10-02
• Study First Submitted: 2018-08-20
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-30
• Last Update Submitted: 2018-09-30
• Study First Posted: 2018-10-02
• Last Update Posted: 2018-10-02
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceramic-on-ceramic	Ceramic-on-ceramic uncemented hip arthroplasty	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).
Metal-on-conventional polyethylene	Metal-on-polyethylene uncemented total hip arthroplasty	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).

Primary Outcome Measures

Name	Time	Method
Osteolysis frequency change between 7 and 15 years	Change between 7 to 15 years after surgery	Osteolysis frequency (%) measured with computed tomography,
Osteolysis size change between 7 and 15 years	Change between 7 and 15 years after surgery	Osteolysis size (cm3) measured with computed tomography

Secondary Outcome Measures

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