Controversy continues to exist regarding the choice of a cementless femoral component in a primary total hip arthroplasty. Both proximally coated tapered stems and fully coated cylindrical stems have excellent clinical results. The incidence of both thigh pain and proximal femoral stress shielding and multiple validated outcome measures were evaluated in a prospective randomized clinical trial with a minimum of two year follow-up comparing a proximally coated tapered femoral stem to a fully coated cylindrical femoral stem.

A prospective randomized clinical trial (RCT) was performed comparing a cylindrical cobalt chrome fully coated femoral stem (Prodigy, Depuy, Warsaw, IN) to a tapered, titanium, proximally porous coated stem (Synergy, Smith & Nephew,

Memphis, TN) with respect to thigh pain, femoral stress shielding and multiple outcome measures.

One hundred and ninety-four patients were enrolled and evaluations were performed pre-operatively, three months, six months and annually. Multiple outcome measures (Harris Hip Score, SF12, WOMAC, Patient Satisfaction Questionnaire, Thigh Pain Questionnaire) were obtained. Sixty-one of these patients were randomized to receive a bone density scan pre-operatively, two weeks post-operatively, six months and annually.

Twelve patients were unavailable for two-year follow-up, leaving one hundred and eighty-two patients evaluated. No significant differences were demonstrated in thigh pain incidence or the multiple outcome measures. Bone density scans demonstrated significantly greater bone density (p< 0.005) in the tapered stem versus the cylindrical stem patients at two-week evaluations from distal femoral reaming. Both stem designs demonstrated statistically significant bone loss in Gruen zones one, six, seven between the two-week and one and two-year evaluations. There were no differences between stem designs although the Prodigy stem demonstrated trends towards greater bone loss in Gruen zones six and seven.

This prospective RCT demonstrated no difference in thigh pain incidence and multiple outcome measures between patients receiving a proximally coated tapered versus a fully coated cylindrical femoral component. Both stem designs demonstrated statistically significant proximal femoral bone loss between the post-operative and two-year evaluations; however, there were no differences between stem designs.

Introduction and Aims: Polyethylene wear continues to be the most significant issue following total hip arthroplasty (THA), leading to the current increase in use of alternative bearing surfaces. We performed a prospective, randomised, blinded clinical trial comparing metal versus polyethylene bearing surfaces in patients receiving THA.

Method: Forty-one patients were randomised to receive a metal (23) or a polyethylene (18) insert with identical femoral and acetabular components. Patients were evaluated pre-operatively at three, six, 12 months and annually thereafter, including an evaluation of erythrocyte and 24-hour urine cobalt, chromium and titanium metal ion levels, validated outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs.

Results: No patients were lost to follow-up. One patient died of unrelated causes. At an average 4.4 (range 3.3–5.1) years follow-up there were no differences in any outcome measures or radiographic findings. Patients receiving metal liners had significantly elevated metal ion measurements. At the latest follow-up erythrocyte cobalt levels were seven times elevated (median 1.2μg/l (metal) Vs 0.18μg/l (poly), p< .001). Urine cobalt levels were 41 times elevated (median 11.9μg/day (metal) Vs 0.29μg/day (poly), p< .001) and urine chromium levels were 14 times elevated (median 4.9μg/day (metal) Vs 0.36μg/day (poly), p< .001). Erthrocyte chromium, titanium and urine titanium were not significantly different between groups. As well, contrary to previous reports, there was not a significant trend towards decreasing ion levels over time.

Conclusion: In this prospective randomised blinded clinical trail comparing metal to polyethyle bearing surfaces, both cobalt and chromium ion levels were significantly elevated in the blood and urine of the patients randomised to receive the metal on metal THA.