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โ† Trials
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Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?

RecruitingNAAges 65 Years - anyAllJointResearch
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In plain words

What the trial is, and whether it could suit you

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. Study design: A prospective single centre blinded randomised controlled trial. Study population: All patients who meet the criteria to undergo a cemented THA.

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patient requiring an elective primary cemented THA. * Male patient โ‰ฅ70 years old and female patient โ‰ฅ65 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. Exclusion Criteria: * The patient is morbidly obese, defined as Body Mass Index (BMI) of โ‰ฅ 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.
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What it tests

  • BiMobile standard cement
  • BiMobile larger cement
  • Avantage standard cement
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Where

1 site
OLVG
Amsterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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