The primary objective of this study is to assess in a safe and controlled manner the optimal loading regime for inducing displacement. The secondary objective is to assess the association between inducible displacement and longitudinal migration,…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Inducible displacement expressed in mm (translations) and degrees (rotations)
measured during the peak-force application of the different loading regimes.
Secondary outcome
The association of the measured induced displacement of the tibial tray
relative to the bone -expressed in translations (mm) and rotations (degrees)-
with the measured longitudinal migration data to identify which combination of
loading regimes (i.e. force applied versus non-weight bearing examinations)
yields the best discrimination between potentially loose and properly fixed
implants.
Background summary
Total Knee Replacement (TKR) is one of the most performed orthopedic procedures
worldwide. If successful, TKR provides pain reduction and restores the function
of the 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
The primary objective of this study is to assess in a safe and controlled
manner the optimal loading regime for inducing displacement. The secondary
objective is to assess the association between inducible displacement and
longitudinal migration, and subsequently to identify the loading regime best
suited to discriminate between loose and fixed prostheses.
Study design
Case control study
Study burden and risks
To guarantee patient safety, all tasks performed by patients in this study will
be accompanied by the coordinating investigator and an experienced radiology
assistant. All tasks patients will be asked to perform will be exercises that
match activities in everyday living. Patients will be given clear instructions
and examples of how to perform the tasks, but will also be told to use their
own insight and limitations meaning that patients can indicate if they feel
that a certain task will provide difficulties and never over-exert themselves.
The effective radiation dose per RSA-radiograph is 3 µSv. Per patients, six
RSA-radiographs will be taken: one supine and one non-weight bearing standing
reference examination, and four *inducible displacement* examinations. This
means the total radiation dose for patients participating in this study will be
6 x 3 µSv = 18 µSv or 0.018 mSv
According to the guidelines of the European Commission the radiation dose falls
in category I, and can be considered trivial.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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 a post-operative examination)
• they participated for at least three years in their respective study and have a usable MTPM-value (i.e. >= 3 bone-markers can be consistently matched with the reference-examination with a CN < 120 over the most recent two years of follow-up
• 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 measurements
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
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL58105.058.16 |