What does the non-specific cytokine response contribute to the prediction of prosthesis fixation (expressed in MTPM after 1 years), compared with simple patient characteristics?
ID
Source
Brief title
Condition
- Other condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Health condition
knieprothese
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximum Total Point Motion at 1 year, measured by RSA.
PAM3Cys and LPS-stimulated cytokine profiles.
Secondary outcome
NA.
Background summary
Aseptic loosening is the most common cause of failure of current joint
replacement arthroplasties in the long term (>10 years after index surgery).
Wear particles cause a sterile periprosthetic inflammatory process, which leads
to osteolysis and formation of fibrous tissue. Pro-inflammatory cytokines play
a major role in this process.
Micromotion preceeds aseptic loosening and can be accurately measured by RSA.
RSA measurements can only be performed if tantalum markers are inserted during
surgery.
Innate immunity can be determined at any time, even pre-operatively. Innate
immunity may even be a useful tool in predicting the preoperative risk of
aseptic loosening.
Study objective
What does the non-specific cytokine response contribute to the prediction of
prosthesis fixation (expressed in MTPM after 1 years), compared with simple
patient characteristics?
Study design
Observational study.
Study burden and risks
The burden for the patient consists of a single venipuncture, to obtain 4 tubes
of blood (32ml).
The foremost risk is a hematoma, there is also a small chance of a phlebitis.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
- Patients over 18 years, who underwent elective knee replacement arthroplasty.
- Patients who are part of an RSA-cohort and whose MTPM at 1 year have been measured.
Exclusion criteria
- No measurable MTPM at 1 year, or inadequate registration.
- Tibia component in frontal plane greater than 5 ° varus or valgus 5.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL30892.058.09 |
| OMON | NL-OMON29081 |