Dual-mobility vs unipolar cups for primary total hip replacement via direct anterior approach

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two hip replacement components in adults undergoing elective primary total hip arthroplasty via the direct anterior approach. Participants are assigned to receive either a dual-mobility cup or a unipolar cup. The trial uses standard clinical procedures and follow-up to monitor outcomes such as dislocation risk, functional recovery, and safety. Eligibility requires French-speaking adults with prior hip condition suitable for primary THA and no prior ipsilateral hip surgery, among other criteria. The study is sponsored by Elsan and conducted at Polyclinique Jean Villar in Bruges, France.

Why it matters

Who can join: the full rules

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).

Where it's running

• Polyclinique Jean Villar
  Bruges, France Recruiting

Study contacts

• Study coordinator: Nicolas Verdier
• Email: dr.nicolas.verdier@gmail.com
• Phone: +33(0)535549569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.