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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

379 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-12-31

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.

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Primary surgery with Dual Mobility Cup

Patients having a Primary Hip acetabular replacement, using a Dual Mobility Cup.

Primary surgery with Dual Mobility Cup

Intervention Type DEVICE

Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.

Revision surgery with Dual Mobility Cup

Patients having a Revision Hip acetabular replacement, using a Dual Mobility Cup.

Revision surgery with Dual Mobility Cup

Intervention Type DEVICE

Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.

Interventions

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Primary surgery with Dual Mobility Cup

Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.

Intervention Type DEVICE

Revision surgery with Dual Mobility Cup

Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.

Intervention Type DEVICE

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.