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
ID
Bron
Verkorte titel
Aandoening
osteoarthritis; reumatoid arthritis for which TKA is performed
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Maximum Total Point Motion (MTPM) in the 6 different RSA acquisitions positions
Achtergrond van het onderzoek
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
Doel van het onderzoek
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
Onderzoeksopzet
Single timepoint
Onderzoeksproduct en/of interventie
RSA acquisitions during 6 different positions of the operated knee to assess the induced migration
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8487 |
| Ander register | METC-LDD, previously CME-LUMC : P16.156; ABR NL58105.058.16 |