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
1 other identifier
interventional
104
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2003
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2003
CompletedFirst Submitted
Initial submission to the registry
August 20, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 2, 2018
September 1, 2018
19.3 years
August 20, 2018
September 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Articulation wear at 7 years
At 7 years after surgery
Articulation wear at 15 years
15 years after surgery
Implant fixation at 7 years
7 years after surgery
Implant fixation at 15 years
At 15 years after surgery
Clinical function at 7 years
7 years after surgery
- +1 more secondary outcomes
Study Arms (2)
Metal-on-conventional polyethylene
ACTIVE COMPARATORUncemented 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).
Ceramic-on-ceramic
EXPERIMENTALUncemented 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).
Interventions
Eligibility Criteria
You may qualify if:
- primary osteoarthritis
- secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)
You may not qualify if:
- inflammatory arthritis
- hip joint infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sahlgrenska University Hospitallead
- Stryker Nordiccollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
August 20, 2018
First Posted
October 2, 2018
Study Start
October 2, 2003
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
October 2, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share