Although the importance of sound statistical principles in the design and analysis of data has gained prominence in recent years, biostatistics, the application of statistics to the analysis of biological and medical data, is still a subject which is poorly understood and often mishandled. This review introduces, in the context of orthopaedic research, the terminology and the principles involved in simple data analysis, and outlines areas of medical statistics that have gained prominence in recent years. It also lists and provides an insight into some of the more common errors that occur in published orthopaedic journals and which are frequently encountered at the review stage in papers submitted to the
Impacted bone allograft is often used in revision joint replacement. Hydroxyapatite granules have been suggested as a substitute or to enhance morcellised bone allograft. We hypothesised that adding osteogenic protein-1 to a composite of bone allograft and non-resorbable hydroxyapatite granules (ProOsteon) would improve the incorporation of bone and implant fixation. We also compared the response to using ProOsteon alone against bone allograft used in isolation. We implanted two non-weight-bearing hydroxyapatite-coated implants into each proximal humerus of six dogs, with each implant surrounded by a concentric 3 mm gap. These gaps were randomly allocated to four different procedures in each dog: 1) bone allograft used on its own; 2) ProOsteon used on its own; 3) allograft and ProOsteon used together; or 4) allograft and ProOsteon with the addition of osteogenic protein-1. After three weeks osteogenic protein-1 increased bone formation and the energy absorption of implants grafted with allograft and ProOsteon. A composite of allograft, ProOsteon and osteogenic protein-1 was comparable, but not superior to, allograft used on its own. ProOsteon alone cannot be recommended as a substitute for allograft around non-cemented implants, but should be used to extend the volume of the graft, preferably with the addition of a growth factor.
We treated 34 patients with recurrent dislocation of the hip with a constrained acetabular component. Roentgen stereophotogrammetric analysis was performed to assess migration of the prosthesis. The mean clinical follow-up was 3.0 years (2.2 to 4.8) and the radiological follow-up was 2.7 years (2.0 to 4.8). At the latest review six patients had died and none was lost to follow-up. There were four acetabular revisions, three for aseptic loosening and one for deep infection. Another acetabular component was radiologically loose with progressive radiolucent lines in all Gruen zones and was awaiting revision. The overall rate of aseptic loosening was 11.8% (4 of 34). Roentgen stereophotogrammetric analysis in the non-revised components confirmed migration of up to 1.06 mm of translation and 2.32° of rotation at 24 months. There was one case of dislocation and dissociation of the component in the same patient. Of the 34 patients, 33 (97.1%) had no further episodes of dislocation. The constrained acetabular component reported in our study was effective in all but one patient with instability of the hip, but the rate of aseptic loosening was higher than has been reported previously and requires further investigation.