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

Completed

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

Interventions: Device: Primary surgery with Dual Mobility Cup
Device: Revision surgery with Dual Mobility Cup

Brief Summary: 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: 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Primary surgery with Dual Mobility Cup	Primary surgery with Dual Mobility Cup	Patients having a Primary Hip acetabular replacement, using a Dual Mobility Cup.
Revision surgery with Dual Mobility Cup	Revision surgery with Dual Mobility Cup	Patients having a Revision Hip acetabular replacement, using a Dual Mobility Cup.

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Implant Dislocation After Surgery	2-year postoperative	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.
Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)	2-year postoperative	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.
Implant Survivorship	2-year postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Performance - PMA Score	2 years postoperative	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
Clinical Performance - HOOS Score	2 years postoperative	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.
Clinical Performance - HARRIS Score	2-year postoperative	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".