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Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach

RecruitingNAAges 18 Years - anyAllElsan
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In plain words

What the trial is, and whether it could suit you

THA comprises the replacement of the damaged bone and cartilage with prosthetic components. The proximal end of the femur is replaced with a stem and ball/head, while the acetabulum is most commonly replaced with a unipolar cup (UP) that consists of a liner inside of a metal shell. UP cups are associated with risks of dislocations, especially in elderly and female patients, as well as in patients with lumbar stiffness or operated for femoral neck fractures. In fact, one of the most common reasons for early revision of UP cups are dislocations. Dual-mobility (DM) cups were introduced in the 1970s by the French surgeon Gilles Bousquet, as an alternative to UP cups. They are made up of two articulations, a femoral head moving inside a mobile polyethylene liner, which in turn moves inside a metal shell. This design allows for a greater jump distance and range of motion (ROM) compared to UP

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * men and women aged ≥18 years old * set to undergo elective primary THA via direct anterior approach (DAA) * affiliated with a social security scheme * able to answer questionnaires and to communicate freely in French * who have been informed and have provided free, informed, and written consent (no later than the day of inclusion and before any examination required by the study) Exclusion Criteria: * with prior ipsilateral hip surgery * with prior contralateral hip surgery * that require acetabular cup diameters ≤50mm (because DM cups are not available from the same manufacturer for diameters ≤50mm, and UP cups require head diameters of 36mm and thus minimum cup diameters of 52mm) * undergoing emergency or trauma surgery (e.g. femoral neck fractures) * with any concomitant disease or disorder which, in the opinion of the surgeon, may put the patient at risk, notably of hip instability or dislocation (hip dysplasia, neuromuscular deficit, fracture sequelae…) or may influence the result of the study * that are pregnant or breastfeeding * under legal protection (guardianship or curatorship or deprived of liberty).
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What it tests

  • Primary total hip arthroplasty using dual-mobility cup
  • Primary total hip arthroplasty using unipolar cup
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Where

1 site
Polyclinique Jean Villar
Bruges, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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