To investigate of the minimal invasive approach is less traumatic in terms of inflammation and tissue damage?
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hemoglobin will be determined in terms of blood loss. Blood loss is also
measured during the operation and post-operatively in terms of drainporduction.
H-FABP tissue damage and IL-6 inflammation reactions
Furthermore the patient will be standard evaluated in terms of range of motion,
prothesis alignement and pain
Secondary outcome
None
Background summary
Replacement of the knee or hip is done in patients with reduced function
because of the pain. The replacement leads to improvement of function and a
better comeback in the community.
The last couple of years a lot of research has been done to reduce the
hospitalisation and a less demanding surgery for the patient.
Recently is the minimal invasive approach (MIS) developed in which a prosthesis
is placed with an incision <10cm.
When research is done to investigate of this procedure is less traumatic than
this can lead to shorter hospitalisation, faster recovery and a better cosmetic
appearance for the patient.
Study objective
To investigate of the minimal invasive approach is less traumatic in terms of
inflammation and tissue damage?
Study design
The patients included in the study will be selected at random to one of the two
study groups. One group is operated using the conventional approach and the
other with the minimal invasive approach.
Intervention
During the trial blood will be collected from the patients pre and
postoperative (2, 4 and 6 hours and day 2 and 4 after surgery)
Study burden and risks
THe patients have the same risks and benefits than patients not included in the
study. The only difference is the blood collection of the patients included in
the study.
Walramstraat 23
6131 BK Sittard
Nederland
Walramstraat 23
6131 BK Sittard
Nederland
Listed location countries
Age
Inclusion criteria
- patients receiving a primary total knee arthroplasty
- patients with osteoarthritis or avascular necrosis
Exclusion criteria
- pregnancy
- clinical relevant disorders, like rheumatoid arthritis, previous knee surgery, standard use of anticoagulantia
- unwilling and unable to cooperate in the study
Design
Recruitment
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 | NL11693.096.06 |