The aim of this study was to investigate the
possible benefit of large-head metal-on-metal bearing on a stem
for primary hip replacement compared with a 28 mm diameter conventional
metal-on-polyethylene bearing in a prospective randomised controlled
trial. We investigated cemented stem behaviour between these two
different bearings using Einzel-Bild-Röntgen-Analyse, clinical and
patient reported measures (Harris hip score, Western Ontario and
McMaster Universities osteoarthritis index, Short Form-36 and satisfaction)
and whole blood metal ion levels at two years. A power study indicated
that 50 hips were needed in each group to detect subsidence of >
5 mm at two years with a
p-value of <
0.05. Significant improvement (p <
0.001) was found in the mean
clinical and patient reported outcomes at two years for both groups.
Comparison of outcomes between the groups at two years showed no
statistically significant difference for mean stem migration, clinical
and patient reported outcomes; except overall patient satisfaction which
was higher for metal-on-metal group (p = 0.05). Metal ion levels
were raised above the Medicines and Healthcare products Regulatory
Agency advised safety level (7 µg per litre) in 20% of the metal-on-metal
group and in one patient in metal-on-polyethylene group (who had
a metal-on-metal implant on the contralateral side). Two patients
in the metal-on-metal group were revised, one for pseudotumour and
one for peri-prosthetic fracture. Use of large modular heads is associated with a risk of raised
whole blood metal ion levels despite using a proven bearing from
resurfacing. The head-neck junction or excess stem micromotion are
possibly the weak links warranting further research.
We compared patient-reported outcomes of the Kinemax fixed- and mobile-bearing total knee replacement in a multi-centre randomised controlled trial. Patients were randomised to the fixed- or the mobile-bearing prosthesis via a sealed envelope method after the bone cuts had been made in the operating theatre. Randomisation was stratified by centre and diagnosis. Patients were assessed pre-operatively and at eight to 12 weeks, one year and two years post-operatively. Validated questionnaires were used which included the Western Ontario MacMasters University, Short-Form 12, Mental Health Index-5, Knee Injury and Osteoarthritis Outcome Score for Knee-Related Quality of Life and Function in Sport and Recreation scales and a validated scale of satisfaction post-operatively. In total, 242 patients (250 knees) with a mean age of 68 years (40 to 80) were recruited from four NHS orthopaedic centres. Of these, 132 patients (54.5%) were women. No statistically significant differences could be identified in any of the patient-reported outcome scores between patients who received the fixed-bearing or the mobile-bearing knee up to two-years post-operatively.