The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
The PURPOSE of this study is to demonstrate the performance and reliability of the Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at a minimum of 24 months post-implantation. The primary endpoint is to determine the dislocation rate observed during post-surgical follow-up. The secondary endpoints are to assess, in the short-term, the following: clinical performance on the basis of clinical scores and hip mobility; radiological performance, particularly in terms of positioning and fixation of the implant; as well as the reliability of the implantation of this acetabular cup on the basis of any complications observed
Study Type
OBSERVATIONAL
Enrollment
379
Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
Number of Participants With an Implant Dislocation After Surgery
The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.
Time frame: 2-year postoperative
Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)
The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.
Time frame: 2-year postoperative
Implant Survivorship
Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.
Time frame: 2-year postoperative
Clinical Performance - PMA Score
Postel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician. It contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) : * a score between 15 and 18 points is defined as good, * a score between 12 and 14 points is defined as average, * a score inferior to 12 is defined as bad
Time frame: 2 years postoperative
Clinical Performance - HOOS Score
The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.
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Time frame: 2 years postoperative
Clinical Performance - HARRIS Score
The HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered "excellent", between 80 and 90 "good", between 70 and 80 "mediocre" and less than 70 "poor".
Time frame: 2-year postoperative