Actively Recruiting
Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
Led by JointResearch · Updated on 2025-02-28
75
Participants Needed
1
Research Sites
539 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient requiring an elective primary cemented THA.
- Male patient 70 years old or older and female patient 65 years old or older.
- 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 will not qualify if you...
- The patient is morbidly obese, defined as Body Mass Index (BMI) of 40 or higher.
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
OLVG
Amsterdam, Netherlands, 1091 AC
Actively Recruiting
Research Team
L
Loes van Beers, MSc
CONTACT
N
Nienk Willigenburg, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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