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

Femur Head Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062450
• Other study ID #: 1204-T-DOUBLEMOB-RM
• Status: Completed
• Phase: N/A
• First received: February 11, 2014
• Last updated: May 2, 2017
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2017
• Source: Tornier, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• patients with tumoral pathology.

Related Conditions & MeSH terms

• Congenital Dislocations
• Dislocations
• Femoral Neck Fractures
• Femur Head Necrosis
• Femur Neck Fracture
• Necrosis
• Osteoarthritis
• Osteoarthritis, Hip
• Post-traumatic Osteoarthritis of Hip Nos
• Primary Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tornier, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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