No registrations found.
ID
Source
Brief title
Health condition
knee osteoartrose, TKA, arthroplasty, MRI, CT, patient specific, matched instruments
knieslijtage, totale knie prothese, patient specifiek
Sponsors and support
Intervention
Outcome measures
Primary outcome
Biomechanical limb alignment, femoral and tibial component position
Secondary outcome
All patients are operated with PSMI. The operating surgeon reviewed all the pre operative digital plans and had the ability to change the default settings provided from the software. Per operative changes of the approved size of the planned femoral and tibial component are noted if approved pre operative planning changed. Mean operation time (incision to closure in minutes) and blood loss (in ml) will be obtained from the operative record.
Background summary
Patient specific matched instruments (PSMI) can be used to align total knee arthroplasty. This technique utilizes CT and MR imaging. The present study is designed to investigate postoperative radiographs, pre operative planning and per operative outcome between CT and MRI based PSMI
Study objective
There is no difference between CT- and MRI-based
Patient specific matched instruments for total knee arthroplasty
Study design
Primary outcome, biomechanical limb alignment, femoral and tibial component position were evaluated on 1 year post operative standardized full leg standing radiographs and sagital plane radiographs
Intervention
Patient specific matched instruments (PSMI) for total knee arthroplasty (TKA) is a new and upcoming technique that uses 3D rapid prototyped disposable guides to align the knee prosthesis. This case control study will review a cohort (n= 899 cases) of patients operated for unilateral total knee arthroplasty (TKA) with the use of patient specific matched instruments (PSMI; Signature, Biomet, Warsaw INC). This PSMI utilizes CT or MR imaging. Patients operated for TKA who were not eligible to undergo MRI and were operated by means of CT-based PSMI will be included. These patients will be adequately matched on gender, age and body mass index (BMI) with a group of patients operated with MRI-based PSMI (Control group) out of the cohort.
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Inclusion criteria
patients operated for unilateral total knee arthroplasty (TKA) with the use of patient specific matched instruments (PSMI
Exclusion criteria
NA
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 |
|---|---|
| NTR-new | NL3956 |
| NTR-old | NTR4122 |
| Other | METC azM/UM / METC Atrium-Orbis-Zuyd : 13N104 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
M.G.M. Schotanus, E.H. van Haaren, R.P.M. Hendrickx, E.J.P. Jansen, N.P. Kort
Eur J Orthop Surg Traumatol. 2015 Aug 12