Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorJointResearch
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BiMobile standard cement
- BiMobile larger cement
- Avantage standard cement
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov