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NCT Number: NCT02062450

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

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Key information

Conditions

Primary Osteoarthritis Bone Diseases Congenital Dislocations Femoral Fractures Femoral Neck Fractures Femur Head Necrosis Femur Neck Fracture Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-traumatic Osteoarthritis of Hip Nos Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary surgery with Dual Mobility Cup

Device

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

Revision surgery with Dual Mobility Cup

Device

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

Primary outcomes

  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 outcomes

  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".

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2014
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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