Migration in Total Hip Arthroplasty with a Cemented BiMobile cup: Better stability with more cement?
- Conditions
- Total Hip Replacementwear of hip joint1002321310005944
- Registration Number
- NL-OMON56284
- Lead Sponsor
- OLVG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 79
- Patients requiring a primary cemented THA.
- Male patients >=70 years old and female patients >=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.
- The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.
- Patient who is expected to need lower limb joint replacement for another
joint within one year.
- The subject has a systemic or metabolic disorder leading to progressive bone
deterioration.
- Patients having a deformity or disease located in other joints than the hip
that needs surgery and is limiting their ability to walk.
- The subject has an active or suspected latent infection in or about the hip
joint.
- The subject*s bone stock is compromised by disease or infection which cannot
provide adequate support and/or fixation to the prosthesis.
- The patient is unable or unwilling to sign the informed consent specific to
this study.
- Subject deemed unsuitable for participation in the study based on the
investigator*s judgement.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Migration of the acetabular cup at two year postoperative, measured with RSA<br /><br>and CT. RSA x-rays will be collected at discharge, 6 weeks, 6 months, 1 year<br /><br>and 2 years after surgery. CT scans will be collected at discharge and 2 years<br /><br>after surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Physical functioning, quality of life, pain and patient satisfaction will be<br /><br>scored with PROMs, consisting of: numeric rating scale (NRS) for pain in rest<br /><br>and during loading, Hip disability and Osteoarthritis Outcome Score Short Form<br /><br>(HOOS-PS), EQ-5D and an anchor question about general daily functioning. All<br /><br>PROMs will be collected prior to surgery, at 6 months, 1 year, 2 years and 5<br /><br>years after surgery. Standard X-rays will be used for analysing the quality of<br /><br>the cement mantle (ie. cement cracks, cortical hypertrophy), component<br /><br>position, rate of radiolucent lines (>2mm), loosening and subsidence. All<br /><br>implant related (serious) adverse events including reoperations and survival of<br /><br>the THA (cup and stem component) will be collected up to 5 years after surgery. </p><br>