Clinical trial NCT02062450: Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
Official title: Multicentre, Observational Study Evaluating the Clinical and Radiological Outcomes of Hip Arthroplasty Using the Dual Mobility Cup
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Osteoarthritis
Post-traumatic Osteoarthritis of Hip Nos
Femur Head Necrosis
Femur Neck Fracture
Congenital Dislocations
Keywords: Arthroplasty
Hip Replacement
Acetabular cup
Dual mobility
Hip revision surgery
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The global cohort: All the patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 and who we were able to be contacted by phone.

"Primary replacement" group: All the patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 for primary hip replacement and who were seen for their follow-up visit at 2 years post-procedure.

"Revision" group: All patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 for revision surgery and who were seen for their follow-up visit at 2 years post-procedure.

All the performance criteria were analysed for the patients in the "Primary replacement" and "Revision" groups

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With an Implant Dislocation After Surgery
timeFrame: 2-year postoperative
measure: Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)
timeFrame: 2-year postoperative
measure: Implant Survivorship
timeFrame: 2-year postoperative
Secondary outcomes:
measure: Clinical Performance - PMA Score
timeFrame: 2 years postoperative
measure: Clinical Performance - HOOS Score
timeFrame: 2 years postoperative
measure: Clinical Performance - HARRIS Score
timeFrame: 2-year postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Caen University Hospital, FR
name: Christophe Hulet, MD, PR
role: PRINCIPAL_INVESTIGATOR
References: