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

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ClinicalTrials.gov Identifier: NCT02062450
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : May 16, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Tornier, Inc.

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.

Condition or disease Intervention/treatment
Primary Osteoarthritis Post-traumatic Osteoarthritis of Hip Nos Femur Head Necrosis Femur Neck Fracture Congenital Dislocations 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

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Study Type : Observational
Actual Enrollment : 379 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicentre, Observational Study Evaluating the Clinical and Radiological Outcomes of Hip Arthroplasty Using the Dual Mobility Cup
Study Start Date : May 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of Participants With an Implant Dislocation After Surgery [ Time Frame: 2-year postoperative ]
    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. Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate) [ Time Frame: 2-year postoperative ]
    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.

  3. Implant Survivorship [ Time Frame: 2-year postoperative ]
    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.


Secondary Outcome Measures :
  1. Clinical Performance - PMA Score [ Time Frame: 2 years postoperative ]

    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. Clinical Performance - HOOS Score [ Time Frame: 2 years postoperative ]
    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.

  3. Clinical Performance - HARRIS Score [ Time Frame: 2-year postoperative ]
    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".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062450


Sponsors and Collaborators
Tornier, Inc.
Investigators
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Principal Investigator: Christophe Hulet, MD, PR Caen University Hospital, FR
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Responsible Party: Tornier, Inc.
ClinicalTrials.gov Identifier: NCT02062450    
Other Study ID Numbers: 1204-T-DOUBLEMOB-RM
First Posted: February 13, 2014    Key Record Dates
Results First Posted: May 16, 2016
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tornier, Inc.:
Arthroplasty
Hip Replacement
Acetabular cup
Dual mobility
Hip revision surgery
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Femur Head Necrosis
Necrosis
Femoral Neck Fractures
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Wounds and Injuries
Osteonecrosis
Bone Diseases
Hip Fractures
Femoral Fractures
Fractures, Bone
Hip Injuries
Leg Injuries