Total Hip Replacement
Conditions
Interventions
Randomisation group A:
25 patients will receive a cemented THA with a BiMobile dual mobility cup, in a
standard size after optimal reaming, resulting in a cement mantle of
approximately 2mm.
Randomi
Sponsors
OLVG
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Migration of the acetabular cup at two year postoperative, measured with RSA and CT. RSA x-rays will be collected at discharge, 6 weeks, 6 months, 1 year and 2 years after surgery. CT scans will be collected at discharge and 2 years after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical functioning, quality of life, pain and patient satisfaction will be scored with PROMs, consisting of: numeric rating scale (NRS) for pain in rest and during loading, Hip disability and Osteoarthritis Outcome Score Short Form (HOOS-PS), EQ-5D and an anchor question about general daily functioning. All PROMs will be collected prior to surgery, at 6 months, 1 year, 2 years and 5 years after surgery. Standard X-rays will be used for analysing the quality of the cement mantle (ie. cement cracks, cortical hypertrophy), component position, rate of radiolucent lines (>2mm), loosening and subsidence. All implant related (serious) adverse events including reoperations and survival of the THA (cup and stem component) will be collected up to 5 years after surgery. | — |
Countries
Netherlands
Outcome results
None listed