To assess the primary stability of the tibial component of the ACS knee arthroplasty by measuring the migration by use of RSA 2 years postoperatively.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the stability of the prosthesis, measured with RSA.
Stability is defined as migration (mm) and rotation (degrees) of the tibial
component in all degrees of freedom
Secondary outcome
Knee disability and Osteoarthritis Outcome Score (KOOS)
Numerical Rating Scale for pain
SF 12
Migration and rotation at the timepoints postoperatively, 3 months, 6 months
and 12 months postoperatively
Background summary
The major cause of TKA failure has been shown to be aseptic loosening. The risk
of early implant migration depends on different factors like prosthetic design,
surface finish and method of fixation. Studies have shown that measuring early
micromotions in TKA implantation is usefull for predicting aseptic loosening
and the need for revision surgery. The level of early micromotions gives us an
important tool for predicting aseptic loosening of the implant.
RSA gives us an accurate measurement of rotation which ranges between 0.15° and
1.15° and between 0.05 and 0.5 mm for translation.
Study objective
To assess the primary stability of the tibial component of the ACS knee
arthroplasty by measuring the migration by use of RSA 2 years postoperatively.
Study design
The study design is a single center prospective open label cohort study
assessing the fixation of the tibial component of the ACS TKA design.
Study burden and risks
During and directly after the operation patients will follow the normal
protocol for Total Knee Arthroplasty followed by standard outpatient clinic
controls at 6 weeks and12 months. The additional burden for patients are;
- additional visits at 3 , 6 and 24 months.
- RSA taken during every visit
- they need to fill out 3 different questionnaires pre- and postoperatively for
a total of 5 times.
Spaarnepoort 1
Hoofddorp 2134TM
NL
Spaarnepoort 1
Hoofddorp 2134TM
NL
Listed location countries
Age
Inclusion criteria
Patients with osteo-arthritis and or destruction of the knee joint
Patients in the age >50 years
Patient is willing to consent and participate in the study by signing and
dating an IRB-approved consent form
Patient willing to be available for follow-up evaluations through two years
post-operative
Exclusion criteria
Patients who are unable or unwilling to cooperate in follow¬-up program
Patients who are mentally or cognitively disturbed
No written and signed Informed Consent.
Patient with a known sensitivity to materials in the device.
Revision of uni or Total Condylar knee exchange
Skeletal Immaturity
Patellectomy
Active, or local infection or systemic infection
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 | NL46461.094.13 |