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General Orthopaedics

Randomized controlled trial of primary total hip replacement comparing cemented stem behaviour between large metal on metal and conventional metal on polyethylene bearing surfaces

British Orthopaedic Association/Irish Orthopaedic Association Annual Congress (BOA/IOA)



Abstract

Introduction

Cemented stems have shown 90–100% survivorship when coupled with polyethylene acetabular component. This study aims to compare cemented stem behaviour in combination with large metal on metal (MOM) vs. metal on poly (MOP) bearings.

Patients and Methods

100 patients were recruited into a single centre RCT (we required 40 in each group for power .90 to confirm stem subsidence of >0.5mm at 2 years; p< 0.05). Recruits were randomized to MOP (28mm) or MOM femoral heads with CPCS cemented femoral stem. Assessments included X-rays (AP pelvis), Harris Hip Scores, blood metal ion levels and patient questionnaires (WOMAC, SF-36, satisfaction questionnaire). Evaluations were done pre-operatively and 3, 12 and 24 months post operatively; blood metal ion measures at 1 year.

Results

There were 50 patients in each arm of study matched for age (64 ± 8.5) and BMI (29.04 ±5.5). There was no difference in femoral stem subsidence at 2 years 1.34 (±1.3) and 1.4 (±1.2) mm for MOM and MOP respectively (p=0.88). There was significant improvement in HHS from pre-op to 3 months: 41 to 87 for MOM and 44 to 86 for MOP (p=0.00). This was maintained with no difference between groups at 2 years (p=0.74). Similar pattern was seen for WOMAC and SF-36 scores for both groups at 2 years (p>0.05). Increased blood Cobalt and Chromium levels were observed in 17% and 0% for MOM and MOP group. MOM group reported better patient satisfaction for overall (91% vs. 79%), pain relief (82% vs 66%) and improvement in ADL activities (94% vs.70%) at 2 years.

Conclusions

There were no significant differences between groups for stem behavior, clinical and patient reported outcomes. Despite higher patient satisfaction reported by MOM patients, increased metal ion levels had raised concerns regarding the use of MOM bearings with cemented stems for primary THR.