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

Summary

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.

Eligibility

Inclusion 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.

Exclusion Criteria:

* 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.

Conditions3

Browse More Trials