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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Per-Erik Johanson，Sahlgrenska University Hospital, Sweden

Tracking Information

First Submitted Date ^ICMJE

August 20, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2, 2003

Estimated Primary Completion Date

December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Osteolysis frequency change between 7 and 15 years[ Time Frame: Change between 7 to 15 years after surgery ]

Osteolysis frequency (%) measured with computed tomography,

Osteolysis size change between 7 and 15 years[ Time Frame: Change between 7 and 15 years after surgery ]

Osteolysis size (cm3) measured with computed tomography

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized study
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Device: Ceramic-on-ceramic uncemented hip arthroplasty
Device: Metal-on-polyethylene uncemented total hip arthroplasty

Study Arms

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).
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).

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

104

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2022

Estimated Primary Completion Date

December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - primary osteoarthritis - secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis) Exclusion Criteria: - inflammatory arthritis - hip joint infection

Sex/Gender

Sexes Eligible for Study:

All

Ages

35 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Per-Erik Johanson，Sahlgrenska University Hospital, Sweden

Study Sponsor ^ICMJE

Sahlgrenska University Hospital, Sweden

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Sahlgrenska University Hospital, Sweden

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名