Evaluation of Predictive Factors for Ruptures of Meije Duo ™ Size 1 and 2 Femoral Stems in Hip Replacement Surgery

Study Overview
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Brief Summary
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A normative development concerning the mechanical resistance tests of the the femoral stems led to contraindicate, in September 2014, to implant Meije Duo ™ femoral stems size 1 or 2 in patients weighing more than 60 kg due to an assumed risk of femoral stem breakage. This contraindication is based on standardized mechanical tests which may have not taken into account the changes in patient weight that may occur after the intervention. To date, investigators have not been aware of any Meije Duo ™ size 1/2 brakeage in our patients implanted with this type of prosthesis regardless of their weights before 2014. However, it is possible that some of them have had a prostheses failure and consulted another hospital. In the absence of a clinical study on this problem, investigators decided to set up a health care assessment study collecting retrospective and prospective information from our patients.

Detailed Description
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First, patients with Meije Duo ™sizes 1 or 2, who had surgery from 2007 to 2014, will be preselected on medical records. The information notice will be sent to them by post. A period of reflection will be respected before contacting the patient to answer their questions concerning the research and its progress and obtain their oral consent to participate in the study. After obtaining consent, investigators will enter the retrospective data collected in the medical and prospective file collected during this call. Patients with at least one of the following criteria: weight> 60 kg and / or long neck / varus and / or DEVANE score ≥ 4, will be selected to have a hip X-ray which will be specially scheduled for the study. This examination will tell us about the state of the prosthesis and of the underlying bone (broken stem, loosening of the implant, bone fracture, dislocation, border, etc. It can be performed in our radiology department of the Diaconesses Croix Saint Simon hospital group or in another radiological center chosen by the patient if the latter cannot come to our hospital. In this case, a prescription for a hip X-ray will be sent to him by post to his current address as well as an information letter intended for the radiology office. The patients who will be included in the study are implanted with Meije Duo ™ 1 and 2 between 2007 to 2014 and will all have a minimum follow-up of 4 years from the date of implantation. The maximum number of rupture complications is observed between the fourth and the eleventh year after fitting the prosthesis. All participants will therefore have a minimum of hindsight required for the evaluation of stem breaks. All of our patients will be contacted by telephone during the study period in chronological order of their previous management for obtaining consent, prospective data and for scheduling the hip radiography according to the criteria mentioned above.

Official Title
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Evaluation of Predictive Factors for Ruptures of Meije Duo ™ Size 1 and 2 Femoral Stems in Hip Replacement Surgery

Conditions
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Hip Arthropathy Associated With Other Conditions

Intervention / Treatment
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* Other: Radiographs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An x-ray of the hip concerned will be performed on all consenting patients, having at least one criterion of the following three during their medical history since the implantation of the hip prosthesis. Weight> 60 kg DEVANE score ≥ 4 Long neck / varus Exclusion Criteria: The patient expresses his opposition to the use of his personal data Patients (<18 years old) Patients unable or out of state to express their consent Patient unable to speak French Patient with memory impairment or cognitive impairment Patient not affiliated to a social security or equivalent health coverage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients implanted with Meije duo stem size 1 or 2<br>Among this arm, patients that meet criteria ( weight> 60kg and / or a long neck / varus and / or a DEVANE score ≥ 4 ) will perform hip X ray | Other: Radiographs<br>* Radiographs of the implanted hip with Meije duo size1 or 2 are performed in eligible patients ( Weigh>60, Long neck stem, Varus; DEVANE score ≥ 4)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pourcentage of participants who had stem (Meije DuoTM size 1 or 2) breakage occured between implantation and the study follow-up call phone. | The number of stem breakage that occured since prostheses implantation will be collected by asking every participant during the follow-up call phone and performing hip xray to eligible ones (see above) | Up to 4 weeks, starting from the call phone (patient consent) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pourcentage of participants who had other prostheses failures (loosening of the prosthesis, femoral fracture, dislocation) | The number of prostheses failures that occured since the implantation will be collected by asking every participant during the follow-up call phone and by performing hip xray to eligible ones (see above) | Up to 4 weeks, starting from the call phone (patient consent) | 
| The change of physical activity in participants from baseline (prostheses implantation) to study call-phone point time. | With DEVANE questionnaire, investigator will assess physical activity of participants | Change from baseline Devane score at postoperative 4 years | 
| The change of the weight and the body mass index (BMI) of the patients after the implantation of Meije DuoTM rods size 1 or 2 | Preoperative weight and BMI of particpantS will be collected from the medical file and postopeartive weight and BMI during follow up call phone | Change from baseline weight and BMI at postoperative 4 years |