The objective is to compare the wear during the years in the two different cups. And if the wear measured on the X-rays is comparable with the daily inconvenience and satisfaction of the patient.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Wear (size and direction)
Harris Hip Score
Womac and SF-36 (satisfaction and function)
Secondary outcome
none
Background summary
The replacement of the hip is done in patients that experience pain and have a
reduced function in the joint and it is done to improve function and better
return in the community. The last couple of years a lot of research has been
done to lengthen the survival of prothesis, in which the patient can postpone
the revision surgery. During a ervision surgery a part of the prosthesis will
be replaced because of wear or loosening. When the prosthesis is used wear
could be seen in the polyethyleen part, when wear is visible patients could
experience inconvenience of the prosthesis. A new cup is developed with highly
crossed linked polyethyleen that will probably have lesser wear. If this can be
determined a revision is not always necessary.
Study objective
The objective is to compare the wear during the years in the two different
cups. And if the wear measured on the X-rays is comparable with the daily
inconvenience and satisfaction of the patient.
Study design
During the study the patients included in the study will have the same routine
control moments (6 weeks, 1, 2, 3 and 5 years) as patients not included in the
study.
Intervention
One group receives an ABGII Stem with a X-3 PE insert and an Trident cup and
the other group receives an ABGII stem with a N2VAc PE insert and an Trident
cup
Study burden and risks
The patients will have the same risks and benefits as patients not included in
the study and receiving an total hip prosthesis. The difference between study
patients and patients not included in the study is that study patients have to
make an extra roentgen foto (RSA-photo) when they have their control moments to
detect the wear. On these photos wear is better visible. This will cause no
more or other harm than the standard X-rays.
Walramstraat 23
6131 BK Sittard
Nederland
Walramstraat 23
6131 BK Sittard
Nederland
Listed location countries
Age
Inclusion criteria
- young patients in the age of 18-65 years
- need uncemented primary THA
- diagnosed with osteoarthritis or avascular necrosis
Exclusion criteria
- other clinical relevant disorders to the hip
- patient received a THA on contralateral side more than 6 months ago but rehabilitation was considered unsatisfactory
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 | NL11792.096.06 |