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The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 12 | Pages 1602 - 1609
1 Dec 2011
Malviya A Ramaskandhan JR Bowman R Hashmi M Holland JP Kometa S Lingard E

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 9 | Pages 1172 - 1179
1 Sep 2008
Wylde V Learmonth I Potter A Bettinson K Lingard E

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.