Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
Key facts
- Where
- Amsterdam, NetherlandsSee the site
Where in Netherlands
- OLVGAmsterdam, NetherlandsContact: Loes van Beers, MScTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- JointResearch
- Trial code
- NCT04049279
- Record updated
- 28 February 2025
- Original description
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.Read full original descriptionShow less
Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement? (Be-Mobile)
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.
Inclusion: 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: 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 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 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.