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

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

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.

Study Overview

• Status: Completed
• Conditions: Femur Head Necrosis; Primary Osteoarthritis; Congenital Dislocations; Femur Neck Fracture; Post-traumatic Osteoarthritis of Hip Nos
• Intervention / Treatment: Device: Primary surgery with Dual Mobility Cup; Device: Revision surgery with Dual Mobility Cup

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

• Study Type: Observational
• Enrollment (Actual): 379

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary surgery with Dual Mobility Cup; Patients having a Primary Hip acetabular replacement, using a Dual Mobility Cup.	Device: Primary surgery with Dual Mobility Cup; 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.	Device: Revision surgery with Dual Mobility Cup; Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Investigators: Principal Investigator: Christophe Hulet, MD, PR, Caen University Hospital, FR

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Arthroplasty; Hip Replacement; Acetabular cup; Dual mobility; Hip revision surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Femoral Fractures; Hip Injuries; Osteonecrosis; Hip Fractures; Osteoarthritis; Necrosis; Osteoarthritis, Hip; Femoral Neck Fractures; Femur Head Necrosis
• Other Study ID Numbers: 1204-T-DOUBLEMOB-RM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No