A Cement Compression Device for cemented TKA

Aseptic loosening is a common problem in joint arthroplasty and one of the most
common indications for revision arthroplasty in total knee arthroplasty (TKA).

Aseptic loosening occurs mostly at the tibia component and might be caused by
suboptimal fixation of the prosthesis. Knee prostheses fixated with bone cement
(Polymethylmethacrylaat = PMMA) have equally good or even better results
regarding aseptic loosening and clinical outcome than knee prostheses fixated
without bone cement. The key to optimize the interfacial strength is achieving
and maintaining maximal infiltration of cement into the bone to obtain large
inter-digitation and a large contact area. To improve the cement penetration a
compression device was designed. This device prevents cement leakage and
improves the cement penetration and distribution into the proximal tibia in a
cadaver model.

It is hypothesized that cementation in the proximal tibia after a TKA with the
new cementing compression device is better compared to the best cementing
technique at the moment (finger packing) regarding cement distribution and
cement penetration in vivo.

The primary objective is to compare cementation during TKA with a new cementing
device to finger packing (the current best cementing technique) regarding
cement distribution and cement penetration of the proximal tibia.

The secondary objective is to compare the operation time for TKA with and
without this new cementing device.

We will perform a prospective randomized controlled trial at the Reinier de
Graaf Hospital, Delft, The Netherlands. Patients will be recruited from the
outpatient clinic of the orthopaedic department and evaluated preoperatively,
operatively, 6 weeks and 3 months after surgery.

use of the cement compression device during cementation of a total knee
arthroplasty

Subjects participating in this stuy have the same risks and benefits when not
participating in this study. We will compare a well recommended technique
(finger packing) with a new technique using a device that is already tested in
a cadaver study. The benefit should be that the penetration and distribution of
the cement in the group using the cementing compression device is more uniform
and predictable. To evaluate the cement distirbution and penetration, a CT scan
of the knee is necessary, 3 months after surgery. This CT scan is extra
compared to regular care.