Comparing cemented hip cups for better stability after surgery

Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement? (Be-Mobile)

This study is testing if using more cement with different sizes of hip cups can help people who have hip surgery feel more stable and reduce the chance of their hip dislocating.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: JointResearch (other)
• Locations: 1 site (Amsterdam)
• Trial ID: NCT04049279 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the early migration of a cemented BiMobile cup in total hip arthroplasty by comparing two different cup sizes and their associated cement mantles. It is a prospective, single-center, blinded randomized controlled trial involving patients undergoing primary cemented total hip arthroplasty. The study will assess whether increasing the amount of cement used for fixation improves stability and reduces the risk of dislocation, a common complication after hip surgery. Additionally, the BiMobile cup's performance will be compared to the Avantage cup, which uses a standard cup size.

Who should consider this trial

Good fit: Ideal candidates are male patients aged 70 and older and female patients aged 65 and older who require elective primary cemented total hip arthroplasty.

Not a fit: Patients who are morbidly obese, have other joint replacements planned within a year, or have systemic disorders affecting bone health may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved stability and reduced dislocation rates in patients undergoing total hip arthroplasty.

How similar studies have performed: Other studies have explored similar approaches with dual mobility cups, but this specific comparison of cement mantle sizes is novel.

Eligibility criteria

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.

Where this trial is running

Amsterdam

• OLVG — Amsterdam, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Rudolf Poolman, MD, PhD — OLVG
• Study coordinator: Loes van Beers, MSc

Conditions: Total Hip Arthroplasty, Osteoarthritis, Hip, primary total hip arthroplasty, RSA, cement, Dual mobility cup