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Compares treatment options for Primary Total Hip Arthroplasty
Official title Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach
ClinicalTrials.gov ID: NCT07464665
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- that are pregnant or breastfeeding
See the full eligibility 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)
- 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...
- that are pregnant or breastfeeding
- under legal protection (guardianship or curatorship or deprived of liberty).
The study team makes the final eligibility decision.
Where it's taking place
- Bruges, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bruges, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.