A randomised clinical trial comparing minimal invasive (MIS) total knee replacement (TKR) with conventional total knee replacement

Rationale: Minimally invasive total hip and knee arthroplasty have increased
enormous in popularity during the last decade, however substantial controversy
exist in the orthopaedic community. For surgery like laparoscopic colorectal
resection, appendicitis, splenectomy and inguinal hernia repair1-4
meta-analyses have been published showing that despite longer operative times,
scopic surgery has advantages like faster recovery and shorter average length
of hospital stay. But does the minimal invasive approach in total knee
replacement has advantages? Or do we compromise excellent long-term results?

Amendement 1: Concerning the quality of the cementing technique in total knee
arthroplasty is little known. Does the MIS approach have an influence on this
cementing technique?

Objective: Does minimal invasive total knee replacement has (at least)
comparable or better results to conventional total knee replacement if looked
at functional recovery, complications and pain.

Amendement 1: measure the accuracy of the cementing technique

Study design: A prospective randomised clinical trial in which 100 cases will
be enrolled.
Patients will be evaluated preoperatively, and postoperatively at discharge
(from operation date to date of discharge), at 6 weeks, at 3 months, 1 year.

Amendement 1: patients will be asked to have one CT scan (diagnostic)

Intervention: Placement of an cemented primary total knee replacement with a
conventional incision or with a minimal invasive approach.

Amendement 1: CT scan

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients participating in the study have the
same risks and benefits when not participating in the study. The minimal
invasive approach is possible through the new instrumentation, which is also
used in the conventional approach. Follow-up times are standard protocol
evaluations of prosthesis. Besides standard radiologic follow-up, patients are
evaluated with routine questionnaires.

Amendement 1: CT scan has acceptable radiation properties, well below the
annual threshold