Primary OsteoarthritisNCT02062450
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
An observational study of Primary Osteoarthritis and Post-traumatic Osteoarthritis of Hip Nos, run by Stryker Trauma and Extremities.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis
- What is being tested?
- Primary surgery with Dual Mobility Cup and Revision surgery with Dual Mobility Cup
- Type of treatment
- Medical device
- How many people
- 379 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- patients with tumoral pathology.
About this study
Official title: 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.
Read the 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
- Conditions
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture, Congenital Dislocations
- Being tested
- Primary surgery with Dual Mobility Cup, Revision surgery with Dual Mobility Cup
- Keywords
- Arthroplasty, Hip Replacement, Acetabular cup, Dual mobility, Hip revision surgery
- Medical subject headings
- Femur Head Necrosis, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary surgery with Dual Mobility CupDevice
Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
Revision surgery with Dual Mobility CupDevice
Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
| Study group | Role | What they receive |
|---|---|---|
| Primary surgery with Dual Mobility Cup | Patients having a Primary Hip acetabular replacement, using a Dual Mobility Cup. Receives: Device: Primary surgery with Dual Mobility Cup | |
| Revision surgery with Dual Mobility Cup | Patients having a Revision Hip acetabular replacement, using a Dual Mobility Cup. Receives: Device: Revision surgery with Dual Mobility Cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2-year postoperative
Secondary outcomes (3)
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
Measured: 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.
Measured: 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".
Measured: 2-year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Hulet, MD, PR, Principal investigator, Caen University Hospital, FR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062450
- Sponsor's protocol ID
- 1204-T-DOUBLEMOB-RM
- Status last verified
- May 2017
- First submitted
- 11 Feb 2014
- Last updated
- 4 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Observational Study Evaluating the Clinical and Radiological Outcomes of Hip Arthroplasty Using the Dual Mobility Cup
- ClinicalTrials.gov ID
- NCT02062450
- Acronym / sponsor ID
- 1204-T-DOUBLEMOB-RM
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Posted 16 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary surgery with Dual Mobility Cup | – | Device: Primary surgery with Dual Mobility CupPatients having a Primary Hip acetabular replacement, using a Dual Mobility Cup. |
| Revision surgery with Dual Mobility Cup | – | Device: Revision surgery with Dual Mobility CupPatients having a Revision Hip acetabular replacement, using a Dual Mobility Cup. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- patients with tumoral pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary surgery with Dual Mobility CupHip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component. | Device | Primary surgery with Dual Mobility Cup |
| Revision surgery with Dual Mobility CupHip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component. | Device | Revision surgery with Dual Mobility Cup |
Primary outcome
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.
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.
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.
3 secondary outcomes
Clinical Performance - PMA Score
Time frame: 2 years postoperative
Clinical Performance - HOOS Score
Time frame: 2 years postoperative
Clinical Performance - HARRIS Score
Time frame: 2-year postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Hulet, MD, PR principal investigator
Caen University Hospital, FR
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Osteoarthritis and Post-traumatic Osteoarthritis of Hip Nos, run by Stryker Trauma and Extremities.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Implant Dislocation After Surgery (time frame: 2-year postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017; AzTrials last refreshed its copy on 26 Oct 2026.