Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?

Launched by JOINTRESEARCH · Aug 6, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how well a specific type of hip implant, called the cemented BiMobile cup, stays in place after surgery. Researchers want to see if using different sizes of the cup and varying the amount of cement around it—either about 2 mm or 4 mm—affects the stability of the implant two years after surgery. They will also compare the performance of the BiMobile cup with another hip implant called the Avantage cup, which uses a standard size and a smaller cement layer. The goal is to find out if more cement leads to better stability for patients who are having total hip replacements due to conditions like osteoarthritis.

To participate in this study, patients must be at least 70 years old if they are male or 65 years old if they are female. They should be scheduled for elective hip replacement surgery and able to follow the study instructions. Participants will need to understand the study and agree to take part by signing a consent form. It's important to note that individuals with certain health issues, such as significant obesity or infections near the hip, will not be eligible. Those who join the study can expect regular follow-up visits to monitor their progress and evaluate the effectiveness of the different implant techniques being tested.

Gender

ALL

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.