Introduction. The origins of the uncemented tapered wedge hip stem design currently offered by several orthopaedic device companies can be linked back to the cemented Straight Mueller type stem design first used in 1977. The design, a wedge shape with a taper angle of 6 degrees, maintains a single medial curvature for all sizes and increases laterally in the width to accommodate different size femurs. Although evolutionary improvements have been made over the years the basic body geometry of the stem has stayed mainly unchanged with excellent clinical survivorship. Over the past decade, the demographics of hip replacement have changed, with a large increase in younger male patients in the age range of 40 to 60 years. In this study the femoral fit of a novel tapered stem, designed to fit a wide array of patient types, is compared to a standard predicate tapered stem design. Methods. A bone morphology study was performed on a patient population of 556 patients using three dimensional digital data from CT-scans. To characterize the fit of the stem designs we analyzed the ratio of a distal (60mm below lesser trochanter) and a proximal (10mm above lesser trochanter) cross section. The same measurements were taken with the standard tapered stem design and the novel tapered stem design, with a given constant implantation height of 20mm above the lesser trochanter. The fit of the stems was classified as Type 1, where there was both proximal and distal engagement, Type 2, proximal engagement only, Type 3, distal engagement only. The distal and proximal engagement, Type 1, was specified with a maximum engagement difference of 2mm proximal to distal. Results. The standard tapered stem showed a well balanced distal to proximal ratio in the median sizes. However, with increasing stem size the distal engagement increases. The novel tapered stem design showed a well balanced proximal to distal ratio throughout the complete size range. With respect to Type 3 fit classification the novel tapered stem design showed a reduced percentage of distal engagements (2.8%) compared to the predicate standard stem (17.2%). In the 40 to 60 year old male group the distal engagements for the standard stem increases (28.2%), whereas the distal engagements for the novel stem remains unchanged (1.3%). Discussion. The cementless, tapered wedge stem design is used in large numbers globally due to its ease of use and reproducibility. However, changing patient demographics and associated bone morphology represents a challenge for existing designs to achieve a proximal fit. The novel tapered stem design presented here was adapted to these influencing factors by optimizing the proximal to distal ratio with respect to the whole patient group resulting in a particularly marked improvement in proximal fit in the male 40–60 age group compared to predicate stem designs

Background. Skeletal stem cells (SSCs) have been used for the treatment of osteonecrosis of the femoral head to prevent subsequent collapse. In isolation SSCs do not provide structural support but an innovative case series in Southampton, UK, has used SSCs in combination with impaction bone grafting (IBG) to improve both the biological and mechanical environment and to regenerate new bone at the necrotic site. Aims. Analysis of retrieved tissue-engineered bone as part of ongoing follow-up of this translational case series. Methods. With Proof-of-Concept established in vitro and in vivo, the use of a living bone composite of SSCs and allograft has been translated to four patients (five hips) for treatment of osteonecrosis of their femoral heads. Parallel in vitro culture of the implanted cell-graft construct was performed. Patient follow-up was by serial clinical and radiological examination. In one patient collapse occurred in both hips due to more advanced disease than was originally appreciated. This necessitated bilateral hip arthroplasty, but allowed retrieval of the femoral heads. These were analyzed for Type 1 Collagen production, bone morphology, bone density and mechanical strength by micro computed tomography (CT), histology (A/S stain, Collagen Type 1 immunostain, biorefringence) and mechanical testing. Representative sections of cortical, trabecular and tissue engineered bone were excised from the femoral heads using a diamond-tipped saw-blade and tested to failure by axial compression. Results. Parallel in vitro analysis demonstrated sustained cell growth and viability on the allograft. Three patients currently remain asymptomatic at up to three year follow-up. Histological analysis of the two retrieved femoral heads demonstrated, critically, Type 1 collagen production in the regenerated tissue as well as mature trabecular architecture, indicative of de novo tissue engineered bone. The trabecular morphology of regenerated bone was evident on CT, and this had a bone density of 1400 Grey scale units, (compared to 1200 for natural trabecular bone and 1800 for cortical bone). On axial compressive testing the regenerated bone on the left showed a 24.8% increase in compressive strength compared to ipsilateral normal trabecular bone, and a 22.9% increase on the left. Conclusions. Retrieval analysis data has demonstrated the translational potential of a living bone composite, while ongoing clinical follow-up shows this to be an effective new treatment for osteonecrosis of the femoral head. Regeneration of the necrotic bone may prevent subsequent collapse, thereby delaying, or possibly avoiding, the need for hip arthroplasty in early stage osteonecrosis. Evaluation of this tissue engineering construct has confirmed the potential for clinical treatment of bone defects using SSC based strategies