Abstract

Introduction:

There has been widespread concern regarding the adverse tissue reactions after metal-on-metal (MoM) total hip replacements (THR). Concerns have also been expressed with mechanical wear from micromotion and fretting corrosion at the head/stem taper junction in total hip replacements. In order to understand the interface mechanism a study was undertaken in order to investigate the effect of surface finish and contact area associated with modular tapers in total hip replacements with a single combination of materials of modular tapers.

Introduction

Optimal results from uncemented total hip arthroplasty (THA) requires the prosthesis to obtain initial stability, restoration of biomechanics, bone contact along the ingrowth surface and uniform stress transfer to the proximal femur. Anatomic variation within the population makes this difficult to reproduce in every patient. To achieve optimal fit and fill of the proximal femur, options are reshaping the canal or creating an implant which precisely fits the patient's anatomy. The former increases bone loss and risks weakening the supporting bone, creating areas of stress concentration or shielding. Computer assisted design-computer assisted manufacture (CAD-CAM) femoral components were designed to overcome these issues. We present the long term results of CAD-CAM femoral components used in primary THA.

Introduction

The variability of the endosteal geometry after removal of the femoral component can make proximal fit difficult to achieve with an ‘off the shelf’ prosthesis. Whatever the anatomy of the proximal femur, it is important to achieve immediate stability, preserve bone stock and protect the femur from cortical defects which can lead to subsequent fracture. In revision Total Hip Arthroplasty (THA) this requires a large inventory of modular components. The use of custom computer-assisted design-computer-assisted manufacture (CAD-CAM) components negates this need. Little has been published on the use of custom-made components in revision THA. We report the results of a cohort of patients who underwent revision THA using CAD-CAM femoral components.

Introduction

A new conservative hip stem has been designed to address the complex problem of total hip arthroplasty in the younger population.

Introduction

Many patients who had previous proximal femoral osteotomies develop deformities that may not be amenable to total hip replacement (THR) with standard off-the-shelf femoral stems. Previous studies have shown high revision rates (18% at 5–10 years follow-up). Computer-assisted-design computer-assisted-manufacture (CAD-CAM) femoral stems are indicated but the results are not known. We assessed the clinical results of THR using CAD-CAM femoral stems specifically for this group of patients.

Introduction

The National Joint Registry has recently identified failure of large head metal on metal hip replacements. This failure is associated with the high torque at the interface of standard modular taper junction leading to fretting and corrosion. A number of manufacturers produce mini spigots, which in theory, provide a greater range of motion as the neck head junction is reduced. However, the relative torque to interface ratio at this junction is also increased. In this study we investigated hypothesis that the use of small spigots (minispigots) will increase wear and corrosion on modular tapers.

Impaction allograft using cement is commonly used in revision surgery for filling bone defects and provides a load bearing interface. However, the variable regeneration of new bone within the defect makes clinical results inconsistent. Previous studies showed that addition of mesenchymal stem cells (MSCs) seeded on allograft can enhance bone formation in the defect site. The purpose of this study is to test the hypothesis that heat generated during cement polymerization will not affect viability of the human MSCs.

The temperatures and durations were taken from previous studies that recorded the maximum temperature generated at the bone-cement interface. Temperatures of below 30 degrees Celsius to over 70 degrees Celsius have been detected and the duration of elevated temperature varies from 30 seconds to 5 minutes. In this study the viability of MSCs cultured at different temperatures was assessed. Ten groups were studied with three repeats (Table 1). A control group in which cells were cultures normally was used.

Culture medium was heated to the required temperature and added to the cells for the required duration. The metabolism of MSCs was measured using the alamar Blue assay, cell viability was analysed using Trypan Blue and cell apoptosis and necrosis were tested using Annexin V and Propidium Iodide staining.

Results showed that cell metabolism was not affected with temperatures up to 48 degrees Celsius for periods of 150s, while cells in the 58 degrees Celsius group eventually died (Fig. 1). Similar results were shown in Trypan Blue analysis (Fig. 2). When comparing the group of cells heated to 48 degrees Celsius for 150s with the control group for apoptosis and necrosis, no significant difference was observed.

The study suggests that human MSCs seeded to allograft can be exposed to temperatures up to 48 degrees Celsius for 150s, which covers many of the situations when cement is used. This indicates that the addition of mesenchymal stem cells to cemented impaction grafting can be carried out without detrimental effects on the cells and that this may increase osteointegration.

Hip resurfacing arthroplasty is emerging as an increasingly popular, conservative option for the treatment of end-stage osteoarthritis in the young and active patient. Despite the encouraging clinical results of hip resurfacing, aseptic loosening and femoral neck fracture remains concerns for the success of this procedure.

This study used finite element analysis (FEA) to analyse the stresses within proximal femoral bone resulting from implantation with a conservative hip prosthesis. FEA is a computational method used to analyse the performance of real-world structures through the development of simplified computational models using essential features.

The aim of this study was to examine the correlation between the orientation of the femoral component of a hip resurfacing prosthesis (using the Birmingham Hip Resurfacing as a model) and outcomes during both walking and stair climbing. The outcomes of interest were stresses in the femoral neck predisposing to fracture, and bone remodelling within the proximal femur.

Multiple three-dimensional finite element models of a resurfaced femur were generated, with stem-shaft angles representing anatomic (135°), valgus (145°), and varus (125°) angulations. Applied loading conditions included normal walking and stair climbing. Bone remodelling was assessed in both the medial and lateral cortices.

Analyses revealed that amongst all orientations, valgus positioning produced the most physiological stress patterns within these regions, thereby encouraging bone growth. Stress concentration was observed in cortical and cancellous bone regions adjacent to the rim of the prosthesis. As one would expect, stair climbing produced consistently higher stress than walking. The highest stress values occurred in the varus-orientated femur during both walking and stair climbing, whilst anatomic angulation resulted in the lowest stress values of all implanted femurs in comparison to the intact femur.

This study has shown through the use of FEA that optimising the stem-shaft angle towards a valgus orientation is recommended when implanting a hip resurfacing arthroplasty. This positioning produces physiological stress patterns within the proximal femur that are conducive to bone growth, thus reducing the risk of femoral neck fracture associated with conservative hip arthroplasty.

Total hip replacements have shown great benefits to patients through relief of pain and restoration of function. However, because of the extensive variation in the size and shape of the femoral canal, especially for the situation encountered in the revision hip arthroplasty, standard uncemented hip systems with a limited number of sizes are unable to provide an accurate fit in every case. This study showed clinical results of 112 primary total hip replacements and 158 revision total hip replacements, using custom made CAD-CAM (Computer Aided Design-Computer Aided Manufactured) hip prostheses inserted between 1992 and 1998.

For primary hip replacements, the implants were designed to produce proximal line-to-line fit with the femoral bone and to provide optimal biomechanical environment of the hip. The stem was HA coated, 53 males and 58 females were included. Mean age was 46.2 years (range 24.6yrs - 62.2 yrs). The average duration of the follow up was 24 years (10 – 17 years). The mean Harris Hip Score (HHS) was improved from 42.4 to 90.3, mean Oxford Hip Score (OHS) was improved from 43.1 to 18.2 and the mean WOMAC hip score was improved from 57.0 to 11.9. There was 1 revision due to failure of the acetabular components but there were no failures of the femoral components. In the whole follow-up period, the survival of the femoral stem alone was 100%.

For revision hip replacements, the implants were designed using our design strategies of graduate approach to different revision situation based on Paprosky's classification of femoral bone defect. The implants were HA coated; some of them had distal cutting flutes. A total of 158 patients (97 males and 61 females) who had operation between 1991 and 1998 were followed up, among them 138 cases were due to aseptic loosening, 6 cases were periprosthetic fractures and 14 cases were infection. The average age was 63.1 years (range 34.6 – 85.9 years). The minimum follow up was 10 years (range 10 – 12 years). The mean Harris Hip Score was improved from 44.2 to 89.3, mean Oxford Hip Score was improved from 41.1 to 18.2 and the mean WOMAC hip score was improved from 52.4 to 12.3 respectively. 6 cases required further revision surgery, among them 3 were due to aseptic implant loosening, the overall survivorship at ten years was 97%.

The CAD-CAM hip stems are able to provide optimal implant fixation and restore hip function for every patient regardless their original femoral shape, bone condition and biomechanics of the hip. The excellent medium to long term clinical results justifies the use of CAD-CAM custom hip stems.

We present the medium to long term clinical results of 112 Uncemented custom Computer Assisted Design Computer Assisted Manufactured (CAD-CAM) total hip arthroplasties performed between 1992 and 1998 in 111 patients. Fifty three males and 58 females were included. Mean age was 46.2 years (range 24.6yrs - 62.2 yrs). Average duration of follow up was 156 months (120 – 204 months). The mean Harris Hip Score (HHS) improved from 42.4 to 90.3, mean Oxford Hip Score (OHS) improved from 43.1 to 18.2 and the mean WOMAC hip score improved from 57.0 to 11.9. There was 1 revision due to failure of the acetabular components but there were no failures of the femoral components. There were no revisions for aseptic loosening. The worst case survival in this cohort of custom femoral components at an average 13 year follow up (range 10-17 years) was 98.2% (95% Confidence interval 95% to 99%). Survival of the femoral component alone was 100%.

These results are comparable with the best medium to long term results for femoral components used in primary total hip arthroplasty (THA) with any means of fixation.

Introduction: Total hip arthroplasty is one of the most frequently performed surgical procedures, with implants usually giving over 90% survival at 10 years. The failure rate is primarily due to aseptic loosening often associated with progressive bone stock loss. Impaction of cancellous morselized allografts with cement can be used for revision total hip arthroplasty in such cases. There is increasing interest in the use of synthetic bone graft substitutes as extenders to allograft due to the shortage and variable quality of allograft. A chemically-pure synthetic calcium phosphate (CaP) allograft extender is compared with allograft alone for acetabular and/or femoral revisions using the Impaction Grafting technique.

Methods: 96 hips in 94 patients underwent revision hip arthroplasty using impaction grafting at 4 sites. Hip revision using impaction grafting was carried out using the Exeter X-Change Instrumentation system, using an Exeter Stem and/or a cemented polyethylene cup. Patients were randomized to receive allograft or CaP plus allograft in a 50:50 volume. Clinical and radiographic assessment was conducted pre-operatively and immediately post-operatively and at 6, 12 and 24 months. Clinical assessments included Harris Hip, Oxford and Charnley modified Merle d’Aubigne scores. Clinical complications were also recorded. Radiographs were assessed for the graft quality, radiolucent lines, lyses or migration, and incorporation of graft. The X-rays were also independently reviewed by an experienced author.

Results: The mean age was 70.2 years (range 41–89 years) with 58 males and 36 females. A total of 40 femoral revisions and 88 acetabular revisions were conducted. There were 46 patients in the ApaPore group, 49 patients in the allograft group and 1 patient who received CaP/allograft and allograft for an acetabular and femoral revision respectively.

No deep infections or adverse events due to the CaP were reported, with no significant difference in complication rates including revision and re-operations. No significant difference in acetabular migration, femoral subsidence, radiolucencies and lyses between the groups was observed. The independent review found no difference between the groups in terms of migration. The bone density was apparently greater for the ApaPore group at 12 months (p=0.001) and 24 months (p=0.012) although the significance of this is unclear. No significant difference in the clinical measures was observed between the groups.

Conclusion: CaP is comparable with allograft in terms of performance and safety when used as an allograft extender for total hip revision arthroplasty using impaction grafting.

Bone marrow cells are well known for improving healing. Recent studies report that stromal cell-derived factor-1 (SDF-1) and its receptor CXC chemokine receptor 4 (CXCR4) play roles in stem cell homing and are related to short-term and long-term engraftment. SDF-1 secreted from an injured organ can pass the endothelium barrier in a CXCR4-dependent manner into the bone marrow and recruit hematopoietic progenitors to the circulation. There is evidence to show that SDF-1 also has chemoat-tractive effects and is able to recruit mesenchymal stem cells and osteoprogenitors. Our previous study also showed that SDF-1 has an enhanced effect on osteoblas-tic differentiation of human mesenchymal stem cells. The purpose of this study is to investigate the effects of genetically modified bone marrow cells that overexpress SDF-1 on bone fracture healing in rat model. The hypothesis is that genetically modified rat bone marrow cells (rBMCs) that over expresses SDF-1 will enhance the fracture healing process compared to non-treated groups or to groups treated with only rBMCs. rBMCs were harvested from femora of young male Wistar rats. rBMCs were expanded ex vivo, and cells of passage 3 were used in the experiment. SDF-1 over-expressing rBMCs (rBMC-SDF-1) were engineered by infection of adenovirus carrying human SDF-1 gene at the multiplicity of infection (MOI) 500. Eighteen adult female Wistar rats were divided into three groups with 6 rats in each group:

rBMC-SDF-1,

A 3mm gap in the middle of femur was created during surgery and stabilized by an external fixator. In two groups three hundred thousand rBMCs or rBMCs-SDF-1 were seeded into a collagen sponge and transplanted into the gap. For the control group, sponges without cells were used. Rats were sacrificed 3 weeks after operation and the femora were harvested. Bone mineral content within the gap was measured immediately after operation and compared with the bone mineral content within the same gap at the third week by dual energy X-ray absorptiometry (DEXA) scanning. The area of new bone formation was measured using histomorphometery on H& E stained sections and quantified by imaging analysis system. In the present study, the rBMC-SDF-1 group showed the most dominant influence in both new bone formation and bone mineral increase. rBMC-SDF-1 not only increases new bone formation but also has higher bone mineral content after 3 weeks compare with the rBMC only. This bone healing progress may due to the enhanced local SDF-1/CXCR4 interaction that recruited more host’s stem cells into the fracture site. The control group showed an increased new bone formation in the histological analysis but a reduced bone mineral content after 3 weeks whereas in comparison the rBMC group showed a similar new bone area to the control group but a significantly higher bone mineral content. This may indicate a faster bone repairing ability with the BMCs. Both rBMC and rBMC-SDF-1 groups have a higher bone mineral content and a more compact new bone structure that may indicate an accelerate effect of rBMC in the bone mineralization. In this study, we show that SDF-1 induces improved bone formation in early fracture healing.

We prospectively evaluated the long-term outcome of 158 consecutive patients who underwent revision total hip replacement using uncemented computer-assisted design-computer-assisted manufacture femoral components. There were 97 men and 61 women. Their mean age was 63.1 years (34.6 to 85.9). The mean follow-up was 10.8 years (10 to 12).

The mean Oxford, Harris and Western Ontario and McMaster hip scores improved from 41.1, 44.2 and 52.4 pre-operatively to 18.2, 89.3 and 12.3, respectively (p < 0.0001, for each). Six patients required further surgery. The overall survival of the femoral component was 97% (95% confidence interval 94.5 to 99.7). These results are comparable to those of previously published reports for revision total hip replacement using either cemented or uncemented components.

We present the 10- to 17-year results of 112 computer-assisted design computer-assisted manufacture femoral components. The total hip replacements were performed between 1992 and 1998 in 111 patients, comprising 53 men and 58 women. Their mean age was 46.2 years (24.6 to 62.2) with a mean follow-up of 13 years (10 to 17). The mean Harris Hip Score improved from 42.4 (7 to 99) to 90.3 (38 to 100), the mean Oxford Hip Score from 43.1 (12 to 59) to 18.2 (12 to 51) and the mean Western Ontario MacMasters University Osteoarthritis Index score from 57.0 (7 to 96) to 11.9 (0 to 85). There was one revision due to failure of the acetabular component but no failures of the femoral component. There were no revisions for aseptic loosening. The worst-case survival in this cohort of custom femoral components at 13.2 years follow-up was 98.2% (95% confidence interval 95 to 99). Overall survival of this series of total hip replacements was 97.3% (95% confidence interval 95 to 99).

These results are comparable with the best medium- to long-term results for femoral components used in primary total hip replacement with any means of fixation.

Background: There is no consensus on the most appropriate prosthesis for treating osteoarthritis (OA) of the hip in young, highly active patients. Modern hip resurfacing is bone conserving, more stable and theoretically easier to revise than total hip arthroplasty. Early results of metal on metal resurfacing have been promising. We have compared two well matched cohorts of patients with regard to function, pain relief and patient satisfaction.

Methods: This prospective study included 2 cohorts of well matched patients treated with hip resurfacing (137 patients, 141 hips) and custom uncemented (CADCAM) stems (134 patients, 141 hips). All procedures were performed by a single surgeon. Outcome measures included Oxford, WOMAC and Harris hip scores. Statistical analysis was performed using the unpaired student’s t- test.

Results: One hundred and thirty four and 137 patients were included in the hip replacement and resurfacing groups respectively. The mean age of these patients was 54.6 years. The mean duration of follow up for the resurfacing group was 19.2 months compared to 13.4 months for the replacement group.

Pre operative oxford, Harris and WOMAC scores in the THA group were 41.1, 46.4 and 50.9 respectively while the post operative scores were 14.8, 95.8 and 5.0. In the HR group, pre- operative scores were 37.0, 54.1 and 45.9 respectively compared to 15.0, 96.8 and 6.1 post operatively. The degree of improvement was similar in both groups.

Conclusion: There was no significant difference in short term outcome between the groups of patients treated with hip resurfacing and total hip arthroplasty in the short term.

Introduction: One of the most important factors affecting the outcome of revision THR of the femoral stem is the variability of femoral endosteal geometry after removal of the in-situ stem. A custom made implant would greatly reduce the inventory of the ‘Off the shelf” (OTS) components. This study presents the medium to long-term results of a cohort of patients with this revision prosthesis.

Methods: During the period November 1991 to November 1998, 158 patients were implanted with a computer-assisted design and computer-assisted manufactured (CAD-CAM) revision prostheses (Stanmore Implants Worldwide, Biomedical Engineering Unit, RNOH) by the senior author (SMA). There were 97 males and 61 females. The average age was 63.1 years (34.6 – 85.9). The indications for revision surgery were aseptic loosening (135 cases, 85.4 %), peri-prosthetic fractures (6 cases, 3.8 %), infection (12 cases, 7.6%) and liner wear (3 cases, 1.9%).

Results: At 10 years all patients reported relief of pre-operative pain and the average hip flexion was 95o (90 o –110o). Oxford, Harris and WOMAC hip scores in the pre-operative and post-operative period were 41.1, 44.2 and 52.4 respectively and 18.2, 89.3 and 12.3 respectively (p< 0.0001, p< 0.0001, p< 0.0001).

There were 6 complications (3.8%) in this series; a periprosthetic fracture of the femoral diaphysis (1), posterior dislocation (2), failure secondary to aseptic loosening of the implant (1) and deep vein thromboses (2)

Discussion: These ten year results are encouraging and suggest that there is a role for the use of custom implants in revision THR, particularly where the anatomical variance of the proximal femur makes the use of OTS implants unsuitable.

Introduction: Finite element (FE) simulation of damage accumulation in the femoral cement mantle is widely used to predict failure of hip prostheses. It is often assumed that the stem-cement interface remains bonded, although debonding is thought to affect cement stress and damage. Rough stems may reduce subsidence, but have been reported to have a detrimental effect on implant survival. Other factors thought to influence cement damage include stem design and orientation and cement thickness. This study investigates the effect of cement mantle thickness and stem malpositioning on cement damage around a smooth, collared implant, and the extent to which this is affected by debonding of the stem-cement interface.

Method: Three FE meshes were built to represent proximal femora with Stanmore Hip prostheses implanted into a thick (2.5 mm) and a thin (1.0 mm) cement mantle, and another thin (1.0 mm) mantle with the implant tilted in varus to achieve a minimal thickness of 0.1 mm laterally. Each model consisted of 4304 eight-noded brick elements with frictional contact at the stem-cement interface. Two analyses were run for each model, in which the stem-cement interface was (a) fully bonded, and (b) fully debonded, with Coulomb frictional contact using a friction coefficient of 0.5. Standardised femur geometry and elastic properties were used. Creep and non-linear damage accumulation in the cement mantle under cyclic loading was modelled using subroutines developed by Stolk et al. (2003). Boundary conditions were applied representing a peak stair-climbing load.

Results: Bonded cases showed extensive cracking around the tip in all cases. Debonded cases had 4–8 times less cracking, which was much more focused at the tip; only the poorly-centralised mantle showed extensive damage elsewhere, in the very thin lateral region. When bonded, the thick mantle had least cracks and the poorly-centralised mantle had most; in the debonded cases, there was no major difference between thick, thin, and poorly-centralised mantles. For each cement mantle geometry, peak maximum principal cement stress was consistently lower in the debonded case than in the bonded case.

Discussion: Our results show greater, more widely distributed cracking in bonded than debonded cement mantles, in contrast with previous studies involving collarless implants. For a collared stem, calcar contact prevents subsidence, allowing cement stress relaxation. A possible explanation for our result is that debonding enhances the stress relaxation process, reducing and redistributing interfacial and shear stresses; thus reducing damage rates. In contrast, a debonded collarless stem subsides continuously, sustaining high cement stress levels and damage rates. These results may explain the disappointing clinical performance of some rough-surfaced prostheses. Our results suggest that bonding might increase both cement damage and its sensitivity to cement thickness. Similar results for all debonded cement mantles indicate that cement thickness may be less critical than previously thought for smooth, collared prostheses. Bonding should not be assumed in FE studies of smooth stems which clinically are likely to debond; cement damage simulation should be extended to incorporate the debonding process.

Introduction & Aims: A new femoral component for hip arthroplasty has been designed for a younger patient population. The design makes use of a higher femoral cut, which conserves bone stock, increasing options for future revision surgery. It uses the existing load bearing properties of the proximal femur, and therefore distributes load more evenly. The stem is longer than that of a resurfacing, so will be easier to insert at the correct orientation, minimising failure rates in inexperienced hands. The cross-sectional dimensions have been designed to produce torsional stability. The collar maximises the loading of the calcar, reducing stress resorption. The surface is hydroxyapatite coated and porous, which will produce a long-term biological fixation.

This project assessed the long-term stability of this design at different orientations, by measuring the change in surface strain distribution following its insertion.

Methods: Ten composite bones were coated in a Photoelastic material, positioned at a simplified single leg stance, and loaded at 2.3 KN. The surface strain was measured at one-centimetre intervals down the medial cortex. Then the prostheses were inserted into the bone at 135°, 145° and 125° to the femoral shaft, and the surface strains reread.

Results: The results were compared with an FEA model, and analysed statistically using the Wilcox signed rank test. The prosthesis inserted at 135° produced no significant difference in surface strain distribution compared with the intact bone.

Conclusions: This study suggests this stem design will be stable in the long term following insertion, and there were no areas of excessively high or low strain.

Introduction: The current practice of impaction allograft to fill large defects in revision total hip replacements is sometimes useful but clinical results are inconsistent. Other studies have shown that addition of mesenchymal stem cells (MSC) in blocks of hydroxyapatite (HA) scaffold can enhance new bone formation in a critical sized defect. However, no study has been conducted on combined MSCs with morselised allograft and HA granules. It is hypothesized that impaction of allograft or HA granules seeded with MSCs or osteoprogenitors will enhance new bone formation compared with the groups without MSCs.

Materials and Methods: Six sheep were used for the study. Each sheep received 8 scaffolds which were embedded in both paraspinal muscles. Groups were: 1) 3.5g allograft, 2) 3.5g allograft with MSCs, 3) 3.5g allograft with osteoblasts; 4) 3.5g of 50:50 allograft/ HA, 5) 3.5g of 50:50 allograft/HA with MSCs, 6) 3.5g of 50:50 allograft/HA with osteoblasts; 7) a block of HA, 8) a block of HA with MSCs. The experimental scaffolds were seeded with either 10x106 MSCs/ml or 10x106 MSC-derived osteoprogenitors/ml, in 3ml autologous plasma. Grafts were impacted twenty times at 3KN. At eight weeks, samples were sectioned for histology analysis. Areas of new bone formation were measured as percentage to total available spaces. ANOVA was used for statistical analysis.

Results: Addition of MSCs increased new bone formation in allograft (4.98%), allograft/HA (5.15%) and HA block (7.09%) compared with their controls at 2.24%, 1.96% and 1.96% respectively. Statistical study showed significant increase in 50:50 allograft/HA with MSCs compared with 50:50 allograft/HA only (p=0.046) and 50:50 allograft/HA with osteoprogenitors (p=0.028). No difference was found in allograft groups. For the HA block groups, addition of MSCs showed a significant new bone increase compared to the control (p=0.028).

Conclusion: Addition of MSCs to the allograft and HA granules will enhance new bone formation after impaction which can be used for revision total hip replacements, especially when allograft and HA is mixed. However, addition of osteoprogenitors has not achieved the similar results. This study encourages a further clinical investigation of impaction tissue-engineered graft to repair bone defects in revision total joint replacements.