In deze studie zal de nauwkeurigheid van peroperatieve meting van de cuppositie door een nieuw ontworpen, onlangs gepatenteerd, meetinstrument worden onderzocht. In de toekomst kan, indien het meetinstrument betrouwbaar blijkt, peroperatief de…
ID
Source
Brief title
Condition
- Other condition
- Joint disorders
Synonym
Health condition
gewrichtskraakbeen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the difference of perioperative measured inclination and anteversion (by using
the device) compared to the values calculated on CT.
Secondary outcome
operating time, complications, such as: infection and pain at the entrancepoint
of the markingpoint.
Background summary
Osteoarthritis of the hip is one of the most common disease in Holland. About
257.400 people in the Netherlands are suffering from this disease. In the Isala
Clinics about 700 primary total hip arthroplasties are performed each year.
Because osteoarthritis is age related the demand for this procedure will
increase. Joint replacing surgery is now world wide one of the most performed
procedures. For this reason the occurence of complications should be kept to a
minimum.
The most important complications are luxation, infection and loosening of
components. Malposistioning of the cup is highly related to luxation and
loosening of components.
The orientation of the acetabular component is defined in anteversion and
inclination. Anteversion is the angle used to define the version of the opening
of the cup to the front of the pelvis. Inclination is the angle which the cup
forms with a horizontal line. Lewinnek defined a *safe zone* in which the cup
would have an optimal position in the pelvis. This safe zone is defined as: 15
+/- 10 degrees anteversion and 45 +/- 10 degrees inclination. In this safe zone
there is an optimal correlation between *range of motion* and stability of the
prosthesis. Correct placement of the cup is usually difficult because of the
absence of reliable intra-operative "landmarks". For this reason, about 50% of
the cups are placed in a different position than the surgeon estimated while
placing the cup during the procedure. It is clear that a method for more
accurate cupposistioning is higly needed.
Study objective
In deze studie zal de nauwkeurigheid van peroperatieve meting van de
cuppositie door een nieuw ontworpen, onlangs gepatenteerd, meetinstrument
worden onderzocht. In de toekomst kan, indien het meetinstrument betrouwbaar
blijkt, peroperatief de cuppositie op geleide van de metingen van het
instrument worden aangepast en dus het postoperatieve complicatierisico
verlagen.
In this study the accuracy of a new device will be tested for placement of the
acetabular component in total hip arthroplasty. In the future this instrument
can contribute to more accurate placement of the acetabular component, so the
incidence of complications can be decreased.
Study design
prospective cohort study.
Intervention
placement of a screw in the pelvis, and increase of operationtime of
approximately 10 minutes.
Study burden and risks
during the operation a screw is inserted in the bone. The screw is about 2 mm
in diameter and is placed in the pelvis (Spina Iliaca Anterior Superior). . The
depth of these pins in the bone is about 1 to 2.0 cm. the risk of this
intervention can be expressed in postoperative pain and infection. A few days
after the procedure a CT-scan will be made. This exposes the patient to some
degree of radiation.
The benefit of participation is that the precise orientation of the
actebularcomponent is known (CT-scan). This is of great importance for the
prognosis of the implant. If malpostioning has occured we can instruct the
patient so that the risk of complications can be reduced.
Admiraal De Ruijterweg 395-2hg
amsterdam 1055mc
NL
Admiraal De Ruijterweg 395-2hg
amsterdam 1055mc
NL
Listed location countries
Age
Inclusion criteria
osteoarthritis of the hip
Exclusion criteria
obesity
hip dysplasia
traumatic hip injury
patients with increased risk for infection
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 | NL42724.075.12 |