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

Stryker Trauma and Extremities

Status

Completed

Conditions

Femur Neck Fracture

Post-traumatic Osteoarthritis of Hip Nos

Congenital Dislocations

Femur Head Necrosis

Primary Osteoarthritis

Treatments

Device: Primary surgery with Dual Mobility Cup

Device: Revision surgery with Dual Mobility Cup

Study type

Observational

Funder types

Industry

Identifiers

NCT02062450

1204-T-DOUBLEMOB-RM

Details and patient eligibility

About

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.

Full 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

Enrollment

379 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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