Ceramic On Metal
DeviceCeramic on Metal articulation using M2a-38™ mm cup
NCT Number: NCT00754520
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Central Finland Central Hospital, Jyväskylä, Finland
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ceramic on Metal articulation using M2a-38™ mm cup
Metal on Metal articulation using M2a-38™ mm cup
Time frame: 2 years post-operatively
CCS is defined as:
a. Total Harris Hip Score > 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following:
The HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70
Time frame: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27.
Time frame: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) is a standardised patient reported outcome measure consisting of 24 items divided into 3 sub-sections: Pain (5 items), stiffness (2 items) and physical function or "Activities of Daily Living; ADL" (17 items). A higher score indicates a worse clinical outcome. The maximum score for each subsection is Pain: 20 - 0; Stiffness: 8 - 0; ADL: 68 - 0.
Time frame: 6 months post-operatively, 1, 2, 3 and 5 years post-operatively
Chromium and Cobalt concentrations in blood are measured in measurement unit nmol/L. The change from baseline analysis is presented.
Time frame: 10 years post-op
Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 10 years post-operative is presented here.
Zimmer Biomet
Industry
A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02108496
Arthritis, Joint Diseases
Indianapolis, Indiana, United States
View Trial DetailsNCT07720024
Arthritis, Blount disease
Pathum Thani, Changwat Pathum Thani, Thailand
View Trial DetailsNCT01818401
Arthritis, Joint Diseases
Nantes, France
View Trial DetailsNCT07710404
Arthritis, Joint Diseases
Faisalābad, Punjab Province, Pakistan
View Trial Details