Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Multicentre, Observational Study Evaluating the Clinical and Radiological Outcomes of Hip Arthroplasty Using the Dual Mobility Cup

Conditions
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Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture, Congenital Dislocations

Intervention / Treatment
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* Device: Primary surgery with Dual Mobility Cup
* Device: Revision surgery with Dual Mobility Cup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women aged over 18, undergoing total hip replacement with insertion of a Dual Mobility acetabular cup between October 2010 and October 2011, capable of attending the 2-year follow-up visit; capable of understanding the information about the study and agreeing to take part in it. Exclusion Criteria: patients with tumoral pathology.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary surgery with Dual Mobility Cup<br>Patients having a Primary Hip acetabular replacement, using a Dual Mobility Cup. | Device: Primary surgery with Dual Mobility Cup<br>* Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.<br>|
| Revision surgery with Dual Mobility Cup<br>Patients having a Revision Hip acetabular replacement, using a Dual Mobility Cup. | Device: Revision surgery with Dual Mobility Cup<br>* Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 2-year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 2-year postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Hip Replacement, Acetabular cup, Dual mobility, Hip revision surgery