Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.
Between 1990 and 1992, we implanted 71 hybrid alumina-on-alumina hip arthroplasties in 62 consecutive patients under the age of 55 years, with a mean age of 46 years at surgery. There were 56 primary and 15 secondary procedures. The prostheses involved a cemented titanium alloy stem, a 32 mm alumina head, and a press-fit metal-backed socket with an alumina insert. Three patients (four hips) died from unrelated causes. Four hips had revision surgery for either deep infection, unexplained persistent pain, fracture of the alumina head, or aseptic loosening of the socket. The nine-year survival rate was 93.7% with revision for any cause as the end-point and 98.4% with revision for aseptic loosening as the end-point. The outcome in the surviving patients (50 patients, 57 hips) with a minimum five-year follow-up (mean eight years) was excellent in 47 hips (82.5%), very good in eight (14%), good in one and fair in one. A thin, partial, lucent line, mainly in zone III was present in 38% of the sockets and one socket had a complete lucency less than 1 mm thick. One stem had isolated femoral osteolysis. There was no detectable component migration nor acetabular osteolysis. This hybrid arthroplasty gave satisfactory medium-term results in active patients. The press-fit metal-backed socket appeared to have reliable fixation in alumina-on-alumina hip arthroplasty. The excellent results using cemented fixation of the stem may be related to the low production of wear debris.
We have carried out a prospective, randomised study designed to compare the long-term stability of the stem of cementless femoral implants with differing surface configurations. A total of 50 hips (46 patients) was randomised into two groups, according to whether the medullary stem had been grit blasted (GB) or coated with hydroxyapatite (HA). Both femoral prostheses were of the same geometrical design. We used Ein Bild Roentgen Analyse femoral component analysis (EBRA-FCA) to assess the stability of the stem. The mean follow-up was for 8.66 years. The mean migration of the stem was 1.26 mm in the HA group compared with 2.57 mm in the GB group (Mann-Whitney U test, p = 0.04). A mixed model ANOVA showed that the development of subsidence was statistically different in the two groups during the first 24 months. After this subsidence increased in both groups with no difference between them. Our results indicate that, with the same design of stem, HA coating enhanced the stability of the femoral stem when compared with GB stems.
We report 17 patients who had grafting of the common peroneal nerve after traction injuries. Sixteen were reviewed at a median follow-up of 36 months. The nerve gap ranged from 7 to 20 cm. A functionally satisfactory result was achieved in six patients (37.5%), a fair result in six and a poor result in four. Seven patients had, in addition, a posterior tibialis tendon transfer; this improved the result in five. Grafting produced some satisfactory results even when the nerve gap was as long as 20 cm.