No registrations found.
ID
Source
Brief title
Health condition
osteoarthritis; reumatoid arthritis for which TKA is performed
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximum Total Point Motion (MTPM) in the 6 different RSA acquisitions positions
Secondary outcome
Translation and Rotation along and about the 3 orthogonal axes in the 6 different RSA acquisition positions
Background summary
Total Knee Replacement (TKR) is one ofthe most performed orthopedic procedures worldwide. If successful, TKR provides pain
reduction and restores the function ofthe joint. Migration of orthopaedic implants can be assessed with sub-millimetre accuracy
using radiostereometric analysis (RSA) and early migration can be used as a predictor of later aseptic loosening. In addition to
migration analysis, RSA could also give valuable results measuring "inducible displacement", which can be defined as the
reversible motion of the prosthesis with respect to the bone as a result of applying a force to the prosthesis. For individual patients,
measuring inducible displacement could potentially provide clinical evidence of a deteriorating bone-implant or bone-cement
interface and therefore a heightened risk of aseptic loosening
Study objective
TKR with large migration in the last 2 PO years show a larger inducible migration compared with TKR with little to no migration in the last 2 PO years
Study design
Single timepoint
Intervention
RSA acquisitions during 6 different positions of the operated knee to assess the induced migration
Inclusion criteria
Patients will be included if
• they underwent TKR for primary as well as secondary gonarthrosis as long as the indication for surgery is
clearly specified
• a minimal set of patient characteristics (age, gender, BMI, co-morbidity) and disease characteristics
(radiological severity, knee function and alignment, status of other knee or hip joints, previous surgeries of the
affected knee) is available.
• they are at least `up to date' in terms of follow-up of their respective study (i.e. the most recent examination was
less than a year ago and patients have apost-operative examination)
• they participated for at least three years in their respective study and have a usable MTPM-value (i.e. >_ 3 bonemarkers
can be consistently matched with the reference-examination with a CN < 120 over the most recent iwo
years of fol low-u p
• their standard RSA data meets the criteria as mentioned in the ISO-standard
• they are willing to participate and able to perform the 4 pre-set tasks for the inducible displacement
Exclusion criteria
Patients will be excluded from participation if they do not meet the inclusion criteria, or if they already underwent
revision surgery of their TKR since the start of the study they were enrolled in.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8487 |
| Other | METC-LDD, previously CME-LUMC : P16.156; ABR NL58105.058.16 |