Status:
RECRUITING
Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
Lead Sponsor:
JointResearch
Conditions:
Total Hip Arthroplasty
Osteoarthritis, Hip
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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, an...
Detailed Description
Rationale: Total hip arthroplasty (THA) is a commonly performed surgery in patients with end-stage osteoarthritis (OA) of the hip. Although it is known as a successful procedure, (recurrent) dislocati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04049279
Start Date
January 1 2019
End Date
May 1 2029
Last Update
February 28 2025
Active Locations (1)
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1
OLVG
Amsterdam, Netherlands, 1091 AC