Actively Recruiting
Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement? (Be-Mobile)
Led by JointResearch · Updated on 2025-02-28
75
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates how the size of a cemented BiMobile dual mobility cup affects its early stability after total hip arthroplasty (THA) in patients with hip osteoarthritis. The study compares migration, which indicates loosening, of the BiMobile cup with either a 2 mm or 4 mm cement layer, and also compares these results to the Avantage dual mobility cup with a standard 2 mm cement mantle. The goal is to determine if using more cement improves implant stability and reduces early loosening. Participants will be randomly assigned to one of three groups: one receiving the BiMobile cup with a standard size and 2 mm cement mantle, another receiving the BiMobile cup one size smaller with a 4 mm cement mantle, and a third group receiving the Avantage cup with a standard size and 2 mm cement mantle. All cups are implanted following optimal bone preparation (reaming). The study is a prospective, single-center, blinded randomized controlled trial. Participants will undergo several follow-up evaluations including X-rays using Radiostereometric Analysis (RSA) at discharge, 6 weeks, 6 months, 1 year, and 2 years post-surgery to measure cup migration. CT scans will also be taken at discharge and 2 years after surgery to assess migration accuracy. Patient-reported outcomes on physical function, quality of life, pain, and satisfaction will be collected before surgery and at multiple points up to 5 years after surgery. The study aims to monitor implant stability and patient experience over time.
CONDITIONS
Brief 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 total hip arthroplasty.
- Male patient 70 years or older and female patient 65 years 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...
- Patient is morbidly obese, defined as Body Mass Index (BMI) of 40 or higher.
- Expected need for lower limb joint replacement for another joint within one year.
- Presence of a systemic or metabolic disorder causing progressive bone deterioration.
- Deformity or disease in other joints besides the hip that limits walking ability and requires surgery.
- Active or suspected latent infection in or around the hip joint.
- Compromised bone stock that cannot adequately support or fix the prosthesis due to disease or infection.
- Unable or unwilling to sign informed consent.
- Deemed unsuitable for participation based on the investigator's judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the outpatient clinic
Duration - Surgery day and hospital stay until discharge
Participants undergo a cemented total hip arthroplasty with one of the assigned dual mobility cups and receive immediate post-operative care.
1 visit (surgery and hospital stay)
Duration - 2 years after surgery
Participants have follow-up visits to monitor implant migration, physical functioning, quality of life, pain, and satisfaction.
RSA x-rays at discharge, 6 weeks, 6 months, 1 year, and 2 years; CT scans at discharge and 2 years; patient reported outcomes prior to surgery, 6 months, 1 year, 2 years, and 5 years
Trial Site Locations
Total: 1 location
1
OLVG
Amsterdam, Netherlands, 1091 AC
Actively Recruiting
Research Team
L
Loes van Beers, MSc
N
Nienk Willigenburg, PhD
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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