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New treatment option for Total Hip Arthroplasty
Official title Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
ClinicalTrials.gov ID: NCT04049279
What this study is testing
- What it's testing
- Objective: The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between two different cup sizes after standard optimal reaming, and consequently adjusting the cement mantle into circa 2 or 4 mm, in patients with a primary cemented total hip arthroplasty (THA). Additionally, the results of the BiMobile cup will be compared to the Avantage cup, which is placed with a standard cup size, resulting in a cement mantle of approximately 2 mm.
- 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 65 and older
You may be able to join if
- Patient requiring an elective primary cemented THA.
- Male patient ≥70 years old and female patient ≥65 years old.
- Ability and willingness to follow instructions and to return for follow-up evaluations.
- The patient is able to understand the meaning of the study and is willing to sign informed consent.
- Understanding the Dutch language.
You likely can't join if
- The patient is morbidly obese, defined as Body Mass Index (BMI) of ≥ 40.
- The patient is expected to need lower limb joint replacement for another joint within one year.
- The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- The patient has a deformity or disease located in other joints than the hip that needs surgery and that is limiting their ability to walk.
- The patient has an active or suspected latent infection in or around the hip joint.
- The patient's bone stock is compromised by a disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
See the full eligibility criteria
- Patient requiring an elective primary cemented THA.
- Male patient ≥70 years old and female patient ≥65 years old.
- Ability and willingness to follow instructions and to return for follow-up evaluations.
- The patient is able to understand the meaning of the study and is willing to sign informed consent.
- Understanding the Dutch language.
- The patient is morbidly obese, defined as Body Mass Index (BMI) of ≥ 40.
- The patient is expected to need lower limb joint replacement for another joint within one year.
- The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- The patient has a deformity or disease located in other joints than the hip that needs surgery and that is limiting their ability to walk.
- The patient has an active or suspected latent infection in or around the hip joint.
- The patient's bone stock is compromised by a disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- The patient is unable or unwilling to sign informed consent for this study.
- The patient is deemed unsuitable for participation in the study based on the investigator's judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
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, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. 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.