The purpose of this study was to evaluate the results of custom-made endoprosthetic reconstruction for both tumourous and non-tumourous conditions around the elbow joint.

28 consecutive cases of endoprosthetic elbow reconstruction, performed between 1989 and 2003, were identified using the unit database. There were 12 males and 16 females, with a mean age 48.9 years, (range 14–84). There were 16 cases of malignant tumour (10 primary, 6 secondary), 3 cases of benign tumour (one each of giant cell tumour, osteoblastoma and pigmented villonodular synovitis) and 10 non-oncological cases, (5 cases of fracture, 3 failed total elbow replacements and 1 infected synostosis). A distal humeral prosthesis was used in 16 patients, distal humeral and proximal ulna in 10 patients, proximal ulna with a humeral component in one patient and proximal radial replacement in one patient. Clinical and radiographic review of all available patients, including a functional assessment with The Toronto Extremity Salvage score (TESS) was undertaken.

28 consecutive cases of endoprosthetic elbow reconstruction, performed between 1989 and 2003, were identified using the unit database. There were 12 males and 16 females, with a mean age 48.9 years, (range 14–84). There were 16 cases of malignant tumour (10 primary, 6 secondary), 3 cases of benign tumour (one each of giant cell tumour, osteoblastoma and pigmented villonodular synovitis) and 10 non-oncological cases, (5 cases of fracture, 3 failed total elbow replacements and 1 infected synostosis). A distal humeral prosthesis was used in 16 patients, distal humeral and proximal ulna in 10 patients, proximal ulna with a humeral component in one patient and proximal radial replacement in one patient. Clinical and radiographic review of all available patients, including a functional assessment with The Toronto Extremity Salvage score (TESS) was undertaken.

Endoprosthetic reconstruction around the elbow joint is effective in a wide range of pathologies, allowing in most cases a reasonable level of function, even following two-stage revision for infection.

An experimental sheep model was used for impaction allografting of 12 hemiarthroplasty femoral components placed into two equal-sized groups. In group 1, a 50:50 mixture of ApaPore hydroxyapatite bone-graft substitute and allograft was used. In group 2, ApaPore and allograft were mixed in a 90:10 ratio. Both groups were killed at six months. Ground reaction force results demonstrated no significant differences (p > 0.05) between the two groups at 8, 16 and 24 weeks post-operatively, and all animals remained active. The mean bone turnover rates were significantly greater in group 1, at 0.00206 mm/day, compared to group 2 at 0.0013 mm/day (p < 0.05). The results for the area of new bone formation demonstrated no significant differences (p > 0.05) between the two groups. No significant differences were found between the two groups in thickness of the cement mantle (p > 0.05) and percentage ApaPore-bone contact (p > 0.05).

The results of this animal study demonstrated that a mixture of ApaPore allograft in a 90:10 ratio was comparable to using a 50:50 mixture.

We have managed 27 patients (16 women and 11 men) with a mean age of 68.4 years (50 to 84), with failed total hip replacement and severe proximal femoral bone loss by revision using a distal fix/proximal wrap prosthesis. The mean follow-up was for 55.3 months (25 to 126). The mean number of previous operations was 2.2 (1 to 4). The mean Oxford hip score decreased from 46.2 (38 to 60) to 28.5 (17 to 42) (paired t-test, p < 0.001) and the mean Harris Hip score increased from 30.4 (3 to 57.7) to 71.7 (44 to 99.7) (paired t-test, p < 0.001). There were two dislocations, and in three patients we failed to eradicate previous infection. None required revision of the femoral stem.

This technique allows instant distal fixation while promoting biological integration and restoration of bone stock. In the short term, the functional outcome is encouraging and the complication rates acceptable in this difficult group of patients.

Introduction: Human bone marrow stromal stem cells(BMSSC’s) have the ability to differentiate into a variety of mesenchymal cell types including osteoblasts, fibroblasts, adipiocytes and myocytes. These stromal cells are involved in the process of bone formation during the healing of fractures. Collagen lyophilisate is a sterile extract of bovine demineralised bone matrix. This material contains proteins removed from bone that may control the differentiation of osteoblasts from BMSSC’s. These proteins are localised within collagen type 1. The aim of this study was to determine the effects of collagen lyophilisate on the osteogenic differentiation of bone marrow stromal stem cells cultured in vitro.

Methods: Bone marrow was aspirated from the iliac crest of a human donor who was undergoing an unrelated elective orthopadic surgical procedure. Stromal stem cells were isolated from marrow, cultured and then characterised using immunofluorescent antibodies to Stro −1, a stromal stem cell marker. 3x10⁴ BMSSC’s were seeded into each of 3 culture wells and incubated with standard growth medium or standard medium with collagen lyophilisate diluted 1:50 or 1:100. Cells were cultured for a maximum duration of 30 days. At selected time intervals until day 30, osteogenic differentiation was assessed by determination of alkaline phosphatase, osteopontin, pro collagen carboxyterminal (type 1 collagen synthesis) and calcium in cultures using specific assays.

Results: Cells cultured in collagen lyophilisate displayed a polygonal morphology early in the culture period and later formed complex aggregates. Cells in control cultures maintained a fibroblstic morphology until confluence. On day 21 alkaline phosphatase activity was significantly higher in collagen lyophilisate containing cultures than control cultures. Osteopontin levels were not enhanced in the collagen lyophilisate containing cultures. Type 1 collagen synthesis was higher in the collagen lyophilisate 1:50 group than all other groups at day 14. No differences in type 1 collagen synthesis were detected between cultures at other time periods. Calcium was not detected in any of the control cultures for the duration of the culture period. In contrast, calcium was detected in collagen lyophilisate containing cultures on day 15.

Conclusion: Collagen lyophilisate resulted in changes in cellular morphology and arrangement. The ability of collagen lyophilisate to enhance alkaline phosphatase activity, increase collagen type 1 expression and stimulate the deposition of calcium in stromal stem cell cultures provides evidence that it has osteogenic properties.

Introduction: Impaction allografting is a technique that is used at revision where the bone stock in the femur is poor. Femoral heads are ground to create morsellised bone, which is impacted down the femur prior to the cementing a new stem into the canal. The results of this technique are variable and there is a high incidence of stem migration. This variation in results may be due to the degree of bone loss or the techniques used to impact the graft. The aim of this study was to quantify the forces currently used in revision hip surgery with impaction allografting.

Methods: To enable these measurements the Exeter slap hammer (Stryker Howmedica) was altered to include a load washer. The load washer had a special cable welded to it so that sterilisation could still be conducted in an autoclave. During surgery the end of the load washer cable is passed to the operator, who is able to connect it to a laptop computer. A specially written Labview program is then used to store the data and determine the impaction forces. The load washer is mounted within the hammer at the point of impact between the sliding mass and the hammer, consequently it is reading the force transmitted to the hammer, not that transmitted to the graft chips. Calibration was performed in an in vitro experiment with a second load washer, which found that the force in the hammer is three times that in the impactor. The force is so much less because it is taken up in the hammer’s inertia.

Conclusions: The impaction forces have been measured during eight operations performed by three different surgeons. The study shows variability between surgeons, and variability between patients operated on by the same surgeon. These readings show that the forces travelling through the impactor range between three to eleven time body weight.

Introduction: Periprosthetic bone loss, brought about by wear particle induced osteolysis, presents a major challenge and compromises outcome in revision Total Hip Replacement. Poor bone stock at revision hip replacement is the main indication for impaction allografting. There are well documented limitations in the use of bone graft. Autogenous bone graft is osseoinductive, though donor site morbidity and the limited amount available restrict its use. An alternative is allogenic bone graft from cadaveric femoral heads. The drawbacks of using allograft are a limited supply and the risk of disease transmission. An alternative may be the use of bone substitute materials. Usually these are used in conjunction with allograft and therefore a number of drawbacks still apply. This study investigates the use of impaction grafting without bone graft. In this study we tested Apopore, 60% porosity, 2–5 mm hydroxyappatite (HA) granules (ApaTech Ltd) in an animal impaction model with allograft as control. Hypothesis Impaction using porous granular HA induces a similar volume of new bone compared with impaction using allograft.

Methods and Materials: Cylindrical defects of 15mm diameter were created in the medial femoral condyles of 12 sheep (6 sheep in each group) and filled with 3.5 grams of either morselised ovine allograft, washed and defatted according to North London Tissue Bank protocols, or porous HA granules impacted with a specially designed impactor, 20 times with a force of 3 KN. This force was similar to that measured during impaction grafting in clinical cases. After 6 weeks the sheep were euthanized, samples embedded in resin and the amount of bone formation measured by histomorphometric analysis.

Results: Under the impaction forces used the HA graft was more impacted than allograft. In the impacted HA graft the average pore size was smaller than for impacted allograft. After 6 weeks more new bone formation was observed at the host implant interface than the middle of the implant in both groups. At the implant host interface there was 26.64% (± 2.13%) new bone formation in the allograft and 21.13% (± 4.51%) new bone formation in the HA implant. In the middle of the implants allograft produced 11.01% (± 2.07%) new bone whilst the HA produced 7.23% (± 4.05%) new bone. Two tailed t-test showed no significance in either region, p=0.28 at the interface and p=0.40 in the middle. Allograft underwent resorption, from 39.37% at time zero to 5.66% (± 2.04%) at 6 weeks, a total reduction of 85%, where as the volume of HA granules remained the same and was 49% at time zero and 48.59% (± 1.69%) at 6 weeks. Two tailed t-test showed a significant difference (p< 0.0001) between allograft and HA at 6 weeks.

Conclusions: This study shows that granular porous HA induced a similar level of bone formation as compared with allograft. Resorption of allograft in this model allowed greater ingrowth of fibrous tissue. This makes the structural scaffold much more porous, compromising stability of the construct. The HA was not resorbed after 6 weeks and hence may be more stable. HA also has the advantage of being readily available. This study demonstrates that a bone substitute material does not need to be mixed with allograft.

Introduction: External fixation is used widely in the management of fractures, despite a relatively high incidence of complication, arising from pin loosening and infection. Diamond like carbon (DLC) is a low surface energy coating that can be applied to external fixator pins and may reduce biofilm formation and infection resulting in a lower incidence of pin loosening. Hydroxyapatite (HA) is well established as a coating to enhance fixation of external fixator pins. This study tests the hypothesis that HA and DLC coatings on stainless steel (SS) external fixator pin shafts modify integration of the implant with soft/hard tissues.

Materials and Methods: An Orthofix external fixator was used to stabilise a tibial osteotomy with 6 self-drilling/tapping 6mm pins in 32 skeletally mature Friesland ewes. Animals were divided into four groups; SS, DLC, HA partially coated (threads only) and HA fully coated (threads and pin shaft). Pin insertion torque was measured using a torque wrench and extraction torque similarly obtained at 10 weeks when animals underwent euthanasia. Pin performance indices (PPI) were calculated as a ratio of extraction to insertion torque x100%. Pin site 2 was preserved for hard grade resin histology and subsequent pin tissue integration analysis. Pin site 3 was used for analysis of the soft tissue pin shaft interface using transmission electron microscopy. Pin site 5 was examined for the presence of biofilm formation using scanning electron microscopy. Pin site 6 was swabbed for microbiological analysis.

Results: SS and DLC pins achieved significantly higher insertion torques compared to HA partially coated pins (p=0.001, 0.002). Both groups of HA coated pins demonstrated a significantly higher, extraction torque and therefore PPI for all pin site positions compared to SS and DLC (p< 0.001– 0.025). The epithelium was found not to be in contact with the pin shaft in all cases. No significant differences were found between the different pin groups for epidermal down growth and dermal contact. Both groups of HA coated pins showed a significantly higher percentage of new bone in direct contact with the embedded threads compared to SS and DLC pins (p< 0.001, p=0.004). The proportion of soft tissue in contact and within the thread, of fully coated HA pins was significantly lower compared to stainless steel (p=0.003, p=0.017), DLC (p=0.004, p=0.002) and HA partially coated pins (p=0.006, p=0.02). Biofilms were evident on all pins except those coated with DLC. More bacteria were observed on the fully HA coated pins. DLC had significantly lower number of bacterial colonies in culture compared to SS (p=0.028) and fully coated HA pins (p=0.005).

Discussion: Coatings of DLC and HA do have a significant affect on hard/soft tissue reactions. However coatings do not have a significant effect on epidermal down growth or dermal attachment to the pin shaft surface. DLC coated pins had the cleanest surface with no bio-film present and significantly lower numbers of bacteria present. Fully HA coated pins despite evidence of bio-film formation, bacteria and high microbiological counts had significantly higher PPI. In addition fully coated HA pins demonstrated significantly reduced amounts of soft tissue at the pin bone interface. Therefore soft tissue reactions may affect bone integration.

Introduction: One of the most common complications following total joint surgery is aseptic loosening. Improving the bone-cement interlock may increase implant longevity. An ideally prepared bony surface is dry; clean; free from marrow, fat and debris; free from active bleeding; and free from micro-organisms. Lavage removes debris, blood and fat from the interstices of the bone surface so as to allow optimal penetration of the cement. The hypothesis that we investigated in this study was that lavage with a detergent solution obtains a greater depth of cement penetration into bone compared with lavage using 0.9% saline, hydrogen peroxide or an alcohol solution.

Methods: The cancellous bone of ovine femoral condyles were cut into 10×10×13mm blocks. Lavage solutions were delivered via a pulsatile system and directed towards one side of the bone block. All blocks were swabbed dry. A high viscosity cement was manually mixed and applied to the sandblasted surface of titanium alloy plate (10×10mm, weight 0.9g ±0.01g). The titanium plate and cement were placed on the irrigated bone block, and a known weight applied to achieve pressurisation. Time, temperature and method were controlled. The prosthesis-cement-bone composite was sectioned perpendicularly, and image analysis used to quantify penetration depths. 10 readings were recorded per block with 6 blocks per lavage group.

Results: Cancellous bone porosity averaged 75.2% (±4.0) . The mean penetration depth in the saline group averaged 3.39mm (± 0.77); 3.04mm (± 0.59) using a 2% alcohol solution; 3.33mm (±0.79) using a 3% hydrogen peroxide solution; and 5.41mm (± 1.30) when using the detergent lavage. There was no significant difference in cement penetration depth between hydrogen peroxide and saline irrigation (p> 0.05), nor with hydrogen peroxide and alcohol irrigation (p> 0.05). Irrigation with saline however, afforded statistically superior cement penetration than that of alcohol lavage (p < 0.012). Irrigation with detergent solution demonstrated significantly greater depth of penetration than all three other lavage groups (saline p< 0.05; alcohol p< 0.05; hydrogen peroxide p< 0.05).

Discussion: Detergents can physically remove particulate matter and emulsify and remove fats, thereby acting to maximise porosity of the cancellous bone network and optimise space for occupation by intruding cement. This study has proven the ability of a detergent solution to provide a clean, debris free cancellous network, which consequently provides a significantly greater depth of cement penetration than other commonly used irrigating agents. It was noted that cement penetration into cancellous bone followed the line and depth of cleaning from lavage. In conclusion, the hypothesis can be accepted, and lavage with a detergent solution affords a statistically greater depth of cement penetration into bone than that of the universally used 0.9% saline lavage.

Introduction: The main problem facing the longevity of total hip replacements (THR) is wear particle induced osteolysis, particularly around the acetabular component. The articulating surfaces produce wear particles that migrate in the fibrous tissue membrane along the acetabular implant-bone interface causing osteolysis and subsequent implant loosening. The hypothesis that we investigated was that uncemented acetabular interfaces are more effective than cemented implants at resisting progressive osteolysis through bone attachment and the formation of a biological seal.

Methods: THR surgery was performed in an ovine model. Implants remained in vivo for 1 year. Femoral heads were roughened in order to generate wear debris and aseptic loosening of the acetabular component. Sheep were randomly assigned to one of three experimental groups: cemented polyethylene, grit blasted or plasma sprayed porous acetabular components with a polyethylene insert. Ground Reaction Force (GRF) data was collected pre-op and at 12, 24, 36 and 52 weeks post op. Retrieved specimens were analysed radiographically, histologically and using Scanning Electron Microscopy (SEM). A mould was made of the polyethylene liner and head penetration rates quantified using a shadowgraph technique. Thin sections through the acetabuli were prepared and image analysis used to quantify fibrous tissue (FT) thickness at the bone-implant interface. Mann-Whitney U tests were used for comparative statistical analysis where p< 0.05 were classified as significant.

Results: GRF demonstrated functional hips. A gradual increase was seen until week 36 followed by a decrease until retrieval suggesting the onset of aseptic loosening. 42.86% of control, 60% of grit blasted and 50% of porous coated components were deemed radiographically loose. Mean linear penetration rates demonstrated significantly less penetration within the porous cups (p=0.003, control and p=0.036, grit blasted). SEM established that wear particles generated were < 1μm in size. Light microscopy of thin sections revealed the common mechanism of loosening involving a resorption wedge at the interface with progressive bone loss. In all cases, the FT layer was greatest at the rim of the cup and gradually decreased towards the apex. The grit blasted group had the thickest FT layer adjacent to the cup. Under polarised light, wear debris was seen packed within macrophages in all sections.

Discussion: GRF data demonstrated grit blasted cups to have least function. This was confirmed through histology as they had the thickest FT layer surrounding the acetabular shell suggesting increased aseptic loosening of its component due to wear particles being able to access the interface more easily. Data corroborates radiographic results. In conclusion, porous and control cups performed better than grit blasted cups. Acknowledgments: EPSRC.

Introduction: Surgeons in the UK and Europe generally use a thinner cement mantle than their counterparts in the USA for the femoral component in total hip replacement (THR). The aim of this study was to compare the performance of different thicknesses of cement mantle using finite element analysis. The measures by which comparison might be made include cement cracking, subsidence, migration and stress shielding. In this study, we use a linear-elastic model of the implanted femur to give a prediction of the stresses in the cement mantle and in the femoral cortex. These measures give an indication of the relative rates of cement cracking and loss of bone stock due to stress shielding. To assess the reliability of our model in representing patients with different bone densities, we use a range of cancellous bone stiffnesses.

Method: Two cadaveric femora from the same donor were sized, reamed and implanted with identical plastic replica femoral components following standard surgical technique for the Stanmore Hip system. One was prepared using UK rasps, over-reaming by ~2mm, the other using US rasps, over-reaming by ~5mm. Serial CT-scans were used to create three-dimensional geometric models of the implanted femora. Two finite element meshes were hand-built in MSC. Marc finite element software, incorporating cortical and cancellous bone, bone cement and prosthesis. Each model consisted of 10,000 eight-noded brick elements, with a fully bonded stem-cement interface. The thick and thin cement mantles had thicknesses of 2.5mm and 1.0mm respectively, in regions where thickness is affected by rasp size. Models were identical in the distal medullary canal. Cortical bone was modelled as transversely isotropic, with longitudinal and transverse moduli of 17.0 and 11.5 GPa. Bone cement was given a modulus of 2.7 GPa. Loading conditions were chosen to represent the heel-strike phase of gait. In order to assess the impact of variability in patient bone density, cancellous bone modulus was varied between 0.06 and 2.90 GPa.

Results: Equivalent stress was examined on the external surface of the cortex and the internal surface of the cement mantle. The lowest cortical bone stresses were proximal and the highest cement stresses around the distal tip of the prosthesis. In the proximal cortex, higher equivalent stresses were observed medially and laterally with a thick cement mantle. Distally, lower cement stresses were observed in the thick cement mantle. With the highest cancellous modulus, there was little difference between the two models. As this modulus was reduced, stress differences between the models became more apparent. For all cancellous bone moduli, peak distal cement stresses were lower and minimum proximal calcar stresses higher in the thick cement mantle.

Discussion: Proximal stress shielding was greatest in the calcar, in agreement with clinical findings. The thicker cement mantle led to less stress shielding in this region. Cement stresses, highest around the distal tip of the prosthesis, were larger in the thin cement mantle. This suggests a higher rate of both cracking and bone resorption in thin cement mantles. Although observed over a range of cancellous bone stiffness, this finding applies particularly to patients with low bone density.

Introduction: Aseptic loosening remains the commonest causes of failure of total hip arthroplasty. Cement mantle defects are associated with aseptic loosening. This study aimed to determine a correlation between surgical approach and cement mantle defects in the Stanmore Hip. The Stanmore total hip replacement was chosen because it has greater than an eighty-five percent survivorship over 25 years and unlike other prostheses with comparable results such as the Charnley total hip, it remains essentially unchanged to date.

Method: This was a retrospective review of all Stanmore hips. AP and lateral radiographs were available for 62 patients operated via the posterior approach and 100 patients operated via the anterolateral approach. The mean cement thickness in all fourteen Gruen zones was estimated for each patient. Gruen zones IV and XI, representing the stem tip, were removed from data relating to mantle thickness. Mantles were graded as less than 2mm, 2–5mm, 5–10mm and more than 10mm. Alignment was also measured.

Results: Fifty-nine percent (32/54) of cement mantle defects are seen in Gruen zones VIII to XIV. The mean cement mantle thickness in A-L approach was 3.11mm compared to 4.23mm with the posterior approach. This corresponds with the frequency of cement mantle defects occurrence. No cement defects were seen in Gruen zones IV or XI. Using the anterolateral approach, defects were observed in 49 out of 1200 zones (4.08%) and using the posterior approach in 6 out of 744 zones (0.81%). With the anterolateral approach, 19 out of 100 cement mantles (19%) had defects, compared to only 3 out of 62 (4.84%) with the posterior approach. Defects were most commonly seen in zones I, V, VIII and XII, which corresponds to valgus and posterior orientation of the stem.

Discussion: The posterior approach does generate a more uniform cement mantle. Several studies suggest that a cement mantle smaller than 2mm or greater than 10mm can be detrimental to the survivorship of the arthroplasty. This study suggests that a deficient cement mantle is more likely using an anterolateral approach.

Introduction: The Resurfacing Hip has been increasingly popular for younger patients. Femoral neck fractures are still the main complication. The problems associated with cement such as thermal necrosis, cement debris and lack of long-term biological fixation, combined with the general use of cementless fixation in young patients invite the question whether a cementless component can be used for resurfacing hip replacement. Given that the cement may reinforce the femoral head preventing collapse, an additional question regarding the effect of bone density in cemented and cementless fixation can be asked. The hypotheses of the study are that:

High bone density will increase the yield point and stiffness of the femoral head and therefore improve the implant fixation.

Materials and Methods: Thirty-six femoral head specimens were obtained from consented patients receiving routine hip arthroplasty. The heads were stored frozen at −20oC until use. pQCT was used to analyse trabecular bone density within each head. Specimens were ranked according to bone density and were assigned to high and low bone density groups. Cemented and cementless fixations were then alternatively assigned to individual heads in each group. Thus the 4 groups included in the study were: High density cemented, high density cementless, low density cemented, and low density cementless. Implantation of Birmingham resurfacing hips was carried out according to recommended surgical procedures. For cementing groups, surgical simplex P bone cement was used. Each sample was potted in a cylindrical polyethylene block for testing. A compressive load up to 5 or 10 KN using a Hounsfield Universal Testing Machine were applied on each sample at a rate of 1 mm min-1. Load versus displacement graphs were plotted for all tests. Yield point and stiffness were measured for each sample.

Results:

For yield point, there is no significant difference between cemented or cementless resurfacing (4169 ± 1420 N vs. 3789 ± 1461 N; P = 0.434). However, the high density heads provide a significantly higher yield point than low density heads (4749 ± 1145 N vs. 3208 ± 1287 N; P = 0.01).

Discussion: Bone density plays an important role in resurfacing hip arthroplasty. Higher bone density will reduce the incidence of fractures comparing with lower density. Therefore, resurfacing THR for the older patients and those with sub-optimal bone density should be used with caution. Consequently, it is suggested that a bone density scan should be routinely applied for those patients who are considered for resurfacing hip replacement. There is no difference between the cemented and cementless fixation in reducing femoral head failure, though cement will increase the stiffness of the bone. The study suggests that cementless resurfacing hip could be an alternative design with its clinical advantages of long-term osseointegration if implant is coated with bio-active materials.

Introduction: Normal limb use in amputees with made to measure external prostheses can be impaired by problems at the stump – socket interface. The development of an Intraosseous Transcutaneous Amputation Prosthesis (ITAP) would overcome the problems by protecting the soft tissues, whilst redistributing high stresses to bone. ITAP creates a breach in the skins protective barrier to infection, hence requires a sufficient soft tissue – implant seal to prevent implant failure. Deer antlers are natural analogues of ITAP, and successfully overcome the problems associated with skin penetrating implants such as infection, marsupilisation and avulsion. In this study, an ITAP device has been developed, with a successful soft tissue – implant interface, based on deer antler morphology. It is hypothesised that sub-epithelial dermal fibroblastic, but not epithelial layer adhesion, is directly responsible for the degree of downgrowth observed around ITAP.

Methods: Eleven pairs of deer antler were used to histologically evaluate the interface between the antler and pedicle, and the soft tissue seal around the antler-pedicle structure. The findings were used to develop a titanium alloy (Ti6Al4V) ITAP device in a goat model. Three to five transcutaneous pins were implanted into the medial aspect of the right tibia of skeletally mature female goats. Four implant designs were tested, Machine Finished Straight (MFS), Hydroxyapatite (HA) Coated MFS, Machine Finished Flanged (MFF) and HA Coated MFF. The 70μ thick HA coating was applied to the implant region abutting the sub-epithelium. The implants remained in situ for four weeks after which the histology of the resulting interfaces were analysed qualitatively and quantitatively for degrees of epithelial downgrowth (marsupilisation) and epithelial/sub-epithelial layer attachment to the implant surface.

Results: The histology of the deer antler showed there to be an extremely small area of epithelial attachment, with negligible downgrowth, arrested by soft tissue adhesion to the underlying pedicle surface. There was a significant increase in pore size and frequency in the pedicle structure (abutting the soft tissues), compared to the antler proper. The MFS ITAP implants were associated with significantly greater downgrowth and reduced epithelial and sub-epithelial layer attachment compared to all other implant designs. The HA coating, and porous flange structure significantly reduced downgrowth and increased sub-epithelial layer attachment. Regression correlation showed that there is a significant negative correlation between the extent of downgrowth and the degree of sub-epithelial dermal fibroblastic layer attachment observed around ITAP implants (All p values < 0.05).

Discussion: Deer antlers successfully overcome the potential problems for ITAP. By artificially recreating some of the aspects of the antler, including layering of porous and bioactive surfaces for tissue adhesion, we have successfully developed an ITAP implant that minimises downgrowth and actively encourages epithelial and sub-epithelial soft tissue adhesion.

Introduction A consensus exists regarding the optimal range of femoral cement mantle thickness in hip replacement. However, within this range surgical preferences differ, surgeons in Europe generally preferring thinner cement mantles whilst those in the US prefer a thicker mantle. For a given implant size, the rasps provided in the US for use with the Stanmore Hip are larger than those used in Europe, producing a thicker cement mantle. The integrity of the femoral cement is considered to be crucial to the long-term survival of cemented hip replacements. Previous studies have used cement cracking under fatigue loading as a comparative measure of implant survival. Damage accumulation levels between different implants are associated with clinical failure rates. The aim of this study was to compare the cracking behaviour of cement mantles of different thicknesses around Stanmore Hip replacements. We hypothesised that a thicker cement mantle would lead to reduced cement cracking.

Methods Ten synthetic femurs (Sawbones) were prepared following standard surgical practice for the Stan-more Hip. Five of these were rasped using the larger US rasp, and five using the European version. Stanmore Hip femoral components were then cemented into the femurs with Palacos-R cement and using a custom insertion rig to ensure good alignment and centralisation, confirmed by radiographs. The femurs were then cyclically loaded with an aggressive 4 kN stair-climbing load for 4 million cycles at 3 Hz. The femurs were sectioned at 5 mm intervals and dye penetrant used to highlight cement cracks. Image analysis software was used to measure cement thickness and crack lengths under light microscopy.

Results The minimum cement mantle thickness per section was found to average 0.8 mm and 2.0 mm for the thin and thick mantle groups respectively, measured around the proximal half of the implant. This was significantly different (p< 0.05). Cracks in the cement mantle were irregularly distributed along the length of the prostheses. We found no significant difference in either the total number or total length of cracks found in each group. These were investigated over the whole mantle and by Gruen Zone.

Discussion The geometric and mechanical properties of human femurs vary considerably, which might be expected to increase dramatically the scatter in any clinical trend relating cement thickness to cracking. Our study, using identical synthetic femurs and well-centralised prostheses to minimise experimental variability, found no difference in cracking. Given this experimental consistency, it is thought that there would be no clinically significant difference in cracking rates between different cement thicknesses within the normal range for the Stanmore Hip replacement. The Stanmore Hip is designed to minimise cement stress. A collar prevents subsidence-related hoop stresses, and smooth corners minimise stress concentration in the cement. It is likely that, for a sub-optimal implant design with higher stress risers, cement thickness might have a more noticeable effect on crack propagation.

Introduction: Wear particle induced osteolysis is one of the main reasons for revision total hip replacements (THRs). Loss in bone stock as a result of aseptic loosening is responsible for inferior results in revision THRs. Results from impaction grafting to fill osteolytic defects are frequently inconsistent. Our hypothesis is that the combination of autologous mesenchymal stem cells (MSCs) and allograft will enhance bone regeneration. This study asks whether: MSCs with allograft scaffolds survive at a normal impaction force during revision THRs.

Method: MSCs were isolated from a sheep iliac crest aspirate, expanded in culture and seeded onto irradiated sheep allografts (n=9). Viability of MSCs was assayed with alamar blue with absorbance measured on day 4 (before impaction). The constructs were then impacted using forces 3, 6, and 9 kN extrapolated in surgery then assayed daily for 6 days. The control was 0 kN. Samples were resin embedded after 10 days for histology and pieces of graft were taken for scanning electron microscopy (SEM).

Results: The 0KN control shows an MSC growth curve with a lag period and log phase. Compared with the control, the 3 and 6 kN showed initial reduction in cell proliferation measured by alamar blue (^p=0.015, ^p=0.002) but recovered by day 8, while 9kN showed a significant reduction (^p=0.011) over the time (Figure 1).

For cell proliferation over time, 3 and 6 kN showed no differences, but 9 kN showed a significant difference between day 4 and day 8 (^p=0.031). SEM and histological analysis showed a network of cuboidal cells on the allograft surface.

Conclusions: The results showed that MSCs recovered from impaction of 3 and 6 kN after an initial reduction in metabolism and exceeded original cell seeding densities with no significant difference in proliferation. Viability of MSCs were not effected by impaction forces up to 6 kN. This study shows that stem cells mixed with allograft are a potential method for repairing bone defects in revision total hip replacements.

Introduction: To investigate the head/neck interface of total hip replacements and to see whether the use of small spigots (minispigots) results in enhanced wear and corrosion of tapers compared to standard spigots and the influence of the surface finish on this.

Methods: In the total hip replacement combinations the heads were made of cobalt-chrome (CoCr) and the stems of titanium alloy (Ti). Firstly wear and corrosion of minisigots were compared with standard spigots (Test 1) and secondly, these minispigots were compared with another minispigot with a smoother taper surface finish (Test 2). The samples were immersed in aerated Ringers solution (37°C) and loaded for 10 million cycles. The specimens surface parameters and profiles were measured before & after the test. Electrochemical static corrosion tests were carried out on the rough & smooth minispigots from Test 2 where the current was measured with constant potential under loaded and non-loaded conditions. A cyclical sinusoidal load of 1500-200 Newtons for 1000 cycles at ~1 Hz was used. Pitting tests measured the current while increasing and then decreasing the potential of non-loaded and loaded specimens. Two newly manufactured rough and smooth minispigots were subjected to the same electrochemical corrosion tests.

Results: In Test 1 the results demonstrated that pre-test the surfaces of the female tapers were similar for all heads. Post-testing the Ra values on the female tapers had become greater for the minispigots compared with standard spigots. An abrupt change was noted on the surface profile of the female taper where it was in contact with the male Ti taper, indicating the the CoCr head had corroded. The Ti male tapers were unchanged. Scanning electron microscopy showed that the coarser profile in the corroded region of the CoCr was similar to the profile on the Ti male taper. Pitting corrosion was evident in the grooves on the CoCr. In Test 2 the smooth spigots were not affected, but in the rough minispigots, Ra values had increased in the female tapers. Static corrosion tests showed evidence of fretting in the rough but not the smooth minispigots. When comparing new rough & smooth minispigots, static corrosion testing with clyclical loading showed that for minispigots with a rough finish the current fluctuated with each cycle. Pitting scans showed a greater hysteresis with the rough minispigot compared with the smooth minispigot indicating potentially greater corrosion in the former.

Conclusion: The cobalt-chrome/titanium alloy combinations where the surface finish on the male taper was coarse, corrosion was increased in minispigots compared with standard spigots. This was due to the smaller area of contact of the minispigot at the interface. This corrosion appears to be mediated through the mechanism of fretting corrosion. Surface finish was crucial and corrosion of the minispigot was reduced if the surface finish was smooth. Manufacturers should investigate the effect of surface finish on the corrosion of their tapers particularly where cobalt-chrome/titanium alloy combinations are used.

Introduction: The survival of massive endoprosthesis replacements is not as successful as conventional joint replacements. The main cause of failure of these implants is aseptic loosening. Bone in-growth onto the implant collar on the shaft of the prosthesis adjacent to the transaction site has been correlated with a decrease in radiolucent lines adjacent to the intramedullary stem and reduced implant loosening. We propose that bone contact and in-growth to the collar may be further enhanced with tissue engineering techniques. The hypothesis of this study was that autologous mesenchymal stem cells (MSCs) suspended within fibrin glue and sprayed onto hydroxyapatite (HA)-coated collars of massive prosthesis will augment bone growth and contact to the implant in an ovine model.

Materials and Methods: MSCs were isolated and expanded in vitro from the iliac crest of six adult sheep. Pre-implantation, 2 x 106 autologous MSCS were suspended in thrombin. During surgery, this mixture was combined with fibrinogen and sprayed onto the proximal and distal HA-coated collars of tibial midshaft prostheses using pressurized air. The implants were cemented into the right hind limb of twelve sheep, six of which received MSCs. Radiographs were taken at 2, 4 and 6 months and bone area within defined regions quantified using image analysis software. After six months, specimens were retrieved and processed for undecalcified histology. Transverse thin sections were prepared through the centre of each collar. Image analysis was used to quantify bone area and contact. Mann Whitney U tests were used for comparative statistical analysis, where p< 0.05 was classified as significant.

Results: Anterior-posterior (AP) radiographs taken at 2, 4, and 6 months showed that animals treated with MSCs produced more bone adjacent to the shaft of the implant. Analysis of bone area on both AP and medio-lateral (ML) radiographs taken after sacrifice showed that stem cell-treated implants encouraged significantly more total bone around the implants at 6 months than the control group (171.94 ± 29.04 mm2, and 87.51 ± 9.81 mm2 bone area, respectively, p = 0.016). Analysis of histological sections shows a significant increase in bone area around midshafts treated with MSCs, compared to the implant controls (53.99 ± 10.64 mm2, and 21.07 ± 7.34 mm2, respectively; p = 0.020). The average surface area contact between the midshaft and bone was almost doubled in the MSC-implant group (19.83 ± 8.73 % contact) than in the control group (8.667 ± 8.667 %, p = 0.196). In the MSC group bone was seen deep within the grooves of the HA coated collar whilst a fibrous soft tissue layer separated the newly formed bone in the control group.

Conclusion: Bone contact and in-growth to massive endoprostheses was significantly improved by spraying the implant with autologous MSCs suspended in fibrin glue. Enhanced fixation using stem cells may help prevent aseptic loosening in these massive implants.

Introduction: Fragility of the bone is widely regarded as a cause of Colles’ Fracture particularly in middle aged or elderly women[1]. However not every fall results in fracture of the wrist. The normal volar angle of the distal radius is said to be about 10 degrees although in one study the mean volar angulation was found to be 12 degrees with a range from 4 to 23 degrees[2]. We hypothesised that the volar angle of the distal radius or the position of the wrist at impact could affect where the peak stresses occurred during a fall onto the outstretched arm. We investigated the effect of these two variables on the location and magnitude of the peak stresses using finite element analysis.

Materials and Method: A finite element model of the distal radius was constructed in MARC (MSC software, USA). The model was developed from CT data of the right wrist of a 46 year old male. The data was examined by edge detection software (Materialise, Belgium). The inner and outer boundaries of the cortex were imported as curves into MARC. A surface mesh of the distal radius was constructed, from which a 3D solid mesh of the distal radius was generated automatically. The volar angle was modified to represent between 5 to 25 degrees in 5 degree increments. The wrist position was also changed for each volar angle. This varied in 5 degree increments from 0 to 35 degrees, and then at 45, 75 and 90 degrees. Material properties assigned to cortical and cancellous bone were 20GPa and 6GPa respectively with a Poisson’s Ratio of 0.3. The model consisted of 17660 8 noded hexahedral elements and was fully fixed at the cut end of the proximal radius. For each volar angle a load of 500N and 400N was applied perpendicularly to the articular surface across the scaphoid and lunate fossa respectively. The magnitude and location of peak stresses in the proximal and distal radius were recorded.

Results: Results show that the location and magnitude of peak stresses vary as a result of wrist position. Distally the stress rises with increasing dorsiflexion and at 35 degrees exceeds the load to failure. The volar angle does not influence the stresses unless it is 20 degrees or more. Proximally the volar angle had no effect, but if the wrist is in more than 75 degrees of dorsiflexion then the peak stresses exceeded the load to failure.

Conclusion: Results show that a fall onto the outstretched arm will produce differential stresses in the radius depending on the position of the wrist at impact. The volar angle affected the stresses in the distal radius at greater than 20 degrees but proximally it did not. Proximally stresses above 130MPa (when the wrist is in more than 75 degrees of dorsiflexion) will subject the wrist to fracture[3]. Distally (when the wrist is in more than 35 degrees of dorsiflexion) with high volar angles (greater than 20 degrees) is likely to produce the conditions for a fracture (cancellous bone has been reported to fail as a result of fracture at 50 MPa [4] and for osteoporotic bone at 0.44MPa [4].

Introduction: ApaPore is a synthetic bone graft extender, made from Hydroxyapatite. It is designed to be used as a 50:50 combination by volume with morcelised bone graft. A typical use for such a product may be in impaction allografting during revision hip surgery. The aim of this study was to compare the mechanical stability of stems inserted using impaction allografting where the graft was composed of a 50:50 mixture of ApaPore and allograft with only allograft.

Methods: Twelve large left sawbones were used in this study, the femoral head was cut off each one and the equivalent cancellous bone was cored out to resemble a femur at revision. Impaction allograft was performed on six of the sawbones, with rinsed human morsellised graft. This procedure was repeated on the remaining six sawbones, with graft produced as a 50:50 mixture by volume of rinsed allograft and blood soaked Apapore. The mechanical test was performed in the red rocket, a six station hydraulic loading machine. The sawbones were mounted in the anatomical position of 7 degrees valgus and 9 degrees posteriorly and the test was run in batches of three. Sinusoidal loading at 2Hz was applied under the following loads: 600N, 1kN, 1.4kN, 1.8kN and 2.2kN, each loading step lasting for 5000 cycles. Migration of the stem during loading was measured using LVDT. Vertical displacement of the prosthesis head was measured using digital height callipers at the beginning and end of each loading step. X-Rays were taken before and after mechanical testing.

Results: There is a significant difference between the groups in the overall displacement of the prosthesis head, measured with the digital height calipers, (Mann-Whitney U Test p=0.01). Total average head movement allograft group: 3.5mm and ApaPore group: 1.8mm. The total average subsidence measured with the LVDT’s was 0.295 mm in the allograft group and 0.119mm in the ApaPore/Allograft group. A sideways displacement of the prosthesis head was observed on the x-rays, which is a direct relationship of head rotation, measurements showed a significantly less rotation in the ApaPore/Allograft group (Mann-Whitney U Test p=0.002).

Conclusions: Rotation of the stem in all planes during loading resulted in a greater observed displacement of the prosthesis head than that measured by the LVDT’s. These results show that ApaPore, when used as a bone graft extender is able to reduce initial rotation and subsidence of the stem. Further research needs to be undertaken to investigate the long-term feasibility of using ApaPore.

Introduction: Impaction allografting allows an initial stable function of revision hip replacements and a method of reconstituting the bone stock. A previous in-vivo ovine study has found that the density of impacted morsellised allograft reduces after six weeks but recovers by twelve weeks. This reduction in density during remodelling may also correspond with a reduced mechanical strength. A probable cause of the low density is osteoclastic bone resorption prior to vascular in growth and the formation of new bone by osteoblasts. BoneSave is a 4–6mm porous granules of hydroxyapatite and tricalcium phosphate, and is designed as be used as a 50:50 mix with morsellised allograft. Bonesave takes a long time to be resorbed and replaced with bone compared with allograft. We hypothesised that the inclusion of BoneSave could slow resorption down and hence maintain the mechanical strength of the graft during remodelling. This study investigated the mechanical strength of BoneSave mixed with allograft at six and twelve weeks after insertion into a defect, with pure allograft as a control.

Methods: Twelve yews were used in this study, half were terminated at six weeks the remainder at twelve. The test site was a 15mm diameter hole, approximately 10mm deep, in the medial femoral condyle. Both femurs were operated on consecutively, with allograft on one side and a BoneSave/allograft mix on the other. After euthanasia the distal femurs were removed and CT scans performed to evaluate density. Sixteen millimetre discs were cut from each femur, exposing the test site 4 mm from its proximal end. These graft site was then subjected to non-destructive compression tests in Zwick loading machine. Bone remodelling in the graft was determined using histology.

Results: Wilcoxon paired test were used to compare densities of the allograft group with the BoneSave group at 6 and 12 weeks, at both time points there was a significant difference between the groups (p< 0.05). There was no statistical difference in the density of the allograft groups between 6 and 12 weeks, or the Bonesave groups between 6 and 12 weeks using the Mann-Whitney U test (p> 0.05). There was no significant difference between the stiffness of the two groups at both time points using the Mann Whitney U test (p> 0.05).

Discussion and Conclusion: This result was unexpected in the allograft group because in a previous study looking at different sized allograft chips there was a significant difference between the density at 6 and 12 weeks. The most likely cause for this is that lower forces were used to impact the graft in this experiment compared with the graft size study. This would have resulted in lower density at time zero, so perhaps this lower density didn’t invoke such a large resorption response. Bone-Save is able to maintain mechanical strength during remodelling when used as a bone graft extender.