The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between 2 different cup sizes after standard optimal reaming, and therefore adjusting the amount of cement into 2 or 4…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Total hip arthroplasty (THA) is a commonly performed surgery in patients with
end-stage osteoarthritis (OA) of the hip. THA is known as a highly successful
procedure that improves the patients* physical functioning and reduces pain.
Although it is known as a successful procedure, (recurrent) dislocation after
THA is a major problem and results in a deterioration in quality of life.
Dislocation after THA is the number one cause of early revision surgery. At one
year follow-up 34,5% of all revisions were due to dislocation in the
Netherlands.
Dual-Mobility (DM) acetabular cups should provide more stability and
biomechanically reduce the risk of (early) dislocation. Potential disadvantages
of DM cups are increased liner wear, psoas impingement and loosening. This
might result in more revision surgery at mid- and longer term follow-up for the
cemented cups. If the cemented fixation technique improves, this might diminish
the disadvantages of more revisions due to loosening in cemented cups. High
quality evidence guiding the best technique for cemented fixation is however
lacking. There is evidence that an optimal reaming should be used, including
the removal of the subchondral bone plate. The risk of implant loosening might
be reduced by increasing the amount of cement used for cup fixation. It is
currently unknown whether size of the implant, and thereby the amount of
cement, affects stability and survival. To fill this gap in knowledge, this
study will compare cup migration, as an indicator for loosening, in a new dual
mobility cup (BiMobile, Waldemar Link GmbH & Co. KG, Hamburg, Germany), using a
larger or smaller cup size (and thereby different amounts of cement:
approximately 2mm or 4mm cement mantle). These results will also be compared
with the Avantage cup (Zimmer), which is yet considered as a standard dual
mobility cup in the Netherlands and Sweden. Migration will be measured with
Rontgen Stereophotogrammetry Analysis (RSA), which is currently the gold
standard for measuring early migration and predicting long term survival. A
relatively new and less intensive way to measure migration of prostheses is the
use of computer tomography (CT) scans, however there is still little scientific
evidence on how accurately this can be done.This study therefore also measures
the accuracy with which migration is measured, between CT scans and RSA.
Study objective
The main objective of this study is to compare the (early) migration of the
cemented BiMobile cup at two year post-surgery between 2 different cup sizes
after standard optimal reaming, and therefore adjusting the amount of cement
into 2 or 4 millimeter, in patients with a primary cemented total hip
arthroplasty. The results of the BiMobile cup will also be compared to the
Avantage cup, which is placed with a standard cup size, resulting in a cement
mantle of approximately 2mm.
Study design
A prospective single centre blinded randomised controlled trial, to compare the
BiMobile cup with a standard amount of cement (standard cup size) after optimal
reaming, with the BiMobile cup with a larger amount of cement (with a one size
smaller cup) after optimal reaming.
A third randomised group will receive the Avantage cup, with a standard amount
of cement. All patients will be followed-up until 5 years after surgery. The
study will be conducted in OLVG Amsterdam.
Intervention
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.
Randomisation group B:
25 patients will receive a cemented THA with a BiMobile dual mobility cup, in
one size smaller than standard after optimal reaming , resulting in a cement
mantle of approximately 4mm.
Randomisation group C:
25 patients will receive a cemented THA with an Avantage dual mobility cup, in
a standard size after optimal reaming, according to the investigator*s
brochure, resulting in a cement mantle of approximately 2mm.
Study burden and risks
The risk for patients participating in this study is minimal, above the known
risks for a total hip arthroplasty procedure. The devices that will be used,
are CE marked and will be used according to it's labelling.
Known benefits of a total hip arthroplasty are reduced pain and an inproved
range of motion of the hip. Although, there is no guarantee that patients will
personally benefit from participation in this study.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64196.100.17 |