Introduction. Intraosseous transcutaneous amputation prostheses (ITAP) provide an alternative means of attaching artificial limbs for amputees. Conventional stump-socket devices are associated with soft tissue complications including; pressure sores and tissue necrosis. ITAP resolves these problems by attaching the exo-prosthesis transcutaneously to the skeleton. The aim of this study is to increase the attachment of dermal fibroblasts to titanium alloy in vitro. Fibronectin (Fn) and laminin 332 (Ln) enhance early cell growth and adhesion. We hypothesize that silanized dual coatings of fibronectin and laminin (SiFnLn) will be more durable when compared with adsorbed dual coating (AdFnLn), and will enhance early fibroblast growth and adhesion compared to single coatings. Methods. The kinetics of dual single and dual protein coating attachment onto titanium alloy was quantified on silanized 10mm diameter discs using radiolabelled Fn (125I-Fn) and Ln (125I-Ln). Sixty discs were polished, sterilized and silanized. Coating durability was assessed when soaked in fetal calf serum (FCS) for 0, 1, 24, 48 and 72hrs. Data was compared to un-silanized Ti discs with the same coatings. Five thousand human dermal fibroblasts were seeded on discs (n = 6) of Ti polished alone (Pol), Ti with adsorbed fibronectin (AdFn), Ti with adsorbed laminin (AdLn), Ti adsorbed dual coating (AdFnLn), Ti silanized (Si), Ti silanized with fibronectin (SiFn), Ti silanized with laminin (SiLn), Ti silanized with a dual coating (SiFnLn) for 24hrs. In order to measure cell adhesion fibroblasts were fixed, vinculin stained using mouse vinculin antibody and alexa fluor. Axiovision Image Analysis software was used to measure cell area, vinculin focal adhesion markers per cell and per unit cell area. Data was analysed in SPSS and significance was assumed at the 0.05 level. Results. Silanized dual coatings bonded to Ti alloy in significantly larger quantities compared with adsorbed coatings at all time points (all p values < 0.05). Fibroblasts cultured on dual coatings were significantly larger, produced more vinculin markers per cell, and per unit cell area compared with single coatings. Cells on SiFnLn were larger with more numerous vinculin markers per cell, and per unit cell area compared with AdFnLn (p<0.05). Conclusion. This study has demonstrated that covalently bonding both fibronectin and laminin to Ti alloy provides a durable, dual coating that enhances early fibroblast growth and attachment compared with either protein coating alone in vitro. Our study showed that there is non-competitive binding of laminin on Ti surfaces in the presence of fibronectin. Dual coatings may be applied to the skin-penetrating region of transcutaneous devices to improve the skin seal and this may have positive implications for the development of ITAP

Aims. The Intraosseous Transcutaneous Amputation Prosthesis (ITAP) may improve quality of life for amputees by avoiding soft-tissue complications associated with socket prostheses and by improving sensory feedback and function. It relies on the formation of a seal between the soft tissues and the implant and currently has a flange with drilled holes to promote dermal attachment. Despite this, infection remains a significant risk. This study explored alternative strategies to enhance soft-tissue integration. Materials and Methods. The effect of ITAP pins with a fully porous titanium alloy flange with interconnected pores on soft-tissue integration was investigated. The flanges were coated with fibronectin-functionalised hydroxyapatite and silver coatings, which have been shown to have an antibacterial effect, while also promoting viable fibroblast growth in vitro. The ITAP pins were implanted along the length of ovine tibias, and histological assessment was undertaken four weeks post-operatively. Results. The porous titanium alloy flange reduced epithelial downgrowth and increased soft-tissue integration compared with the current drilled flange. The addition of coatings did not enhance these effects. Conclusion. These results indicate that a fully porous titanium alloy flange has the potential to increase the soft-tissue seal around ITAP and reduce susceptibility to infection compared with the current design. Cite this article: Bone Joint J 2017;99-B:393–400

Introduction. Following amputation, residual stumps used to attach the external prostheses can be associated with sores, infection and skin necrosis. These problems could be overcome by off loading the soft tissues. Intraosseous transcutaneous amputation prostheses (ITAP) attach external implants directly to residual bone reducing these complications. However, a tight seal at the skin implant interface is crucial in preventing epithelial down-growth and infection. Fibronectin (Fn) and laminin 332 (Ln), enhance early cell growth and adhesion of keratinocytes. Silanization to titanium alloy (Ti) allows these proteins to bond to the metal directly. We hypothesize that silanized dual coatings of fibronectin and laminin (SiFnLn) will be more durable than absorbed proteins and that keratinocyte adhesion will be increased compared with Ti controls and single silanized proteins. Methods. 10 mm diameter Ti alloy discs were polished, sterilized and silanized. The kinetics of silanized single and dual protein coating attachment onto titanium alloy was quantified using radio-labelled Fn(125I-Fn) and Ln(125I-Ln). Coating durability was assessed when soaked in fetal calf serum (FCS) for 0, 1, 24, 48, 72hrs. Data was compared to un-silanized Ti discs with the same amount of adsorbed proteins. In order to study cell attachment 20 × 103 keratinocytes were seeded on the discs (n = 6): silanized (Si), silanized fibronectin (SiFn), silanized laminin (SiLn), silanized dual coating (SiFnLn) for 1, 4 and 24hrs. Adhesion of cells was assessed using mouse vinculin antibody for 2hrs and alexafluor for 1hr which stains focal adhesions responsible for attaching cells to surfaces. Axiovision Image Analysis software was used to measure cell area, vinculin markers per cell unit and per unit cell area on 15 cells per disc. Data was analysed in SPSS and significance was assumed at the 0.05 level. Results. Silanized dual coatings bonded to Ti alloy in significantly larger quantities compared with adsorbed coatings (all p values < 0.05). When proteins were combined on silanized discs the same amount of each protein was attached as when used as a single coating (i.e. non competitive binding). Keratinocytes cultured on silanized dual coatings were significantly larger, produced more vinculin markers per unit cell and per cell area compared with single coatings at all time points. Conclusion. This study has demonstrated that silanized using dual proteins on Ti alloy enhances early keratinocyte growth and attachment in vitro. It also shows that there is non-competitive binding of laminin to Ti alloys in presence of fibronectin. This may lead to improved epidermal attachment to ITAP creating a tight seal at the implant interface, which will prevent migration of the epithelium and subsequent infection in vivo

Aims

Periprosthetic fractures (PPFs) following hip arthroplasty are complex injuries. This study evaluates patient demographic characteristics, management, outcomes, and risk factors associated with PPF subtypes over a decade.

Aim. Previous studies of primary internal fixation of infected non-unions have reported high failure rates. Local antibiotic carriers and coatings have been advocated to reduce infection around implants and allow bone healing. We evaluated the effect of a calcium sulphate/hydroxyapatite antibiotic-loaded composite on bone healing and the eradication of infection in combination with internal fixation. Method. Twelve cases of established infected non-union, with segmental bone loss of up to 1cm were treated using a multidisciplinary protocol. This included; excision, deep sampling, stabilisation, local and systemic antibiotics, and soft-tissue closure. We treated 5 femurs, 4 humeri, 1 tibia and 2 periarticular non-unions at the ankle. Mean age was 59.8 years (34–75) and 9 patients had systemic co-morbidities (C-M Type B hosts). 9 patients had single stage surgery, with 5 IM Nails and 4 plates. Three patients had planned second stage internal fixation after external fixation to correct deformity. Staph. aureus was the commonest pathogen (5 cases) with polymicrobial infection in 3 cases. Results. All 12 patients were infection-free at a mean follow-up of 23 months (range 13–34 months). Union was achieved in 11/12 (92%) with the primary surgery alone. The single failure was the tibial case, who remains with an infection-free, stiff non-union. Conclusion. This protocol offered good results, mainly with a single stage treatment. Primary internal fixation was possible in 9 cases, without recurrent infection. The combination of excision of infected dead bone and a high level of local antibiotics above the Minimum Inhibitory Concentration and Minimum Biofilm Eradication Concentration levels for common bacteria, allowed a high success rate in these difficult cases

Introduction. The postoperative management of patients after total hip replacement traditionally includes restrictions of movements and the use of aids (toiletelevation, sleeping pillow, a.o.) in the first 3 months after operation. Few studies have investigated the benefit of such restrictions. The aim of the present study was to evaluate how patients with total hip replacements (THR) are doing with and without restrictions in the first 3 months after surgery, and if walking ability and patients satisfaction was influenced by the postoperative regime. Patients and Methods. 80 patients undergoing primary uncemented THR were randomized to either the conventional regime with restrictions of movement and obligatory use of aids, or a postoperative regime without restrictions. Surgery was performed through a posterolateral short incision. The femoral component was the uncemented Bimetric prosthesis, non collared with HA coating, and a 36 mm femoral head. The cup was the Trilogy cup with a highly crosslinked polyethylen liner. No postoperative drainage was used and immediate weight bearing was allowed in both groups. We monitored walking speed, TUG score (timed up and go) and VAS pain score. The patients were scored by a trained physiotherapist preoperatively, 2 times each day during admission, and 14 and 90 days after surgery. Radiographic examination was performed after 3 days and after 3 months. At the 3 months evaluation a SF-36 score was registered. Results. The two groups were similar in age, operation time blood loss, and position of the prosthesis. None of the patients had postoperative dislocation. No significant difference was seen in any of the registered parameters (p< 0,05). The two groups were not similar regarding pain score. Preoperatively there was a significant higher pain score(p<0,05) in the group without restrictions and this difference was present throughout the first postoperative days. Accordingly they spent more time walking 10m during the first postoperative days, though this difference was not statistically significant. After 3 months the results in the two groups were similar and the SF-36 score was without significant difference. Conclusion. There is no significant difference in TUG test, 10m test, SF 36 score and VAS score the first 3 months after THR in the 2 groups. We did not see an increase in postoperative complications, which implies that postoperative mobilisation without restrictions, can be allowed without the risk of increased complications, and the use of aids in activities of daily living are not necessary. This also implies the possibility of savings in the rehabilitation of patients after THR

INTRODUCTION. The lifetime of UHMWPE implants may be limited by wear and oxidative degeneration. Wear produced particles are in general biologically active, and may induce osteolysis. As threshold of PE wear rate below which osteolysis is rarely observed is postulated to be less tahn 0.1 mm per year. Moreover, PE delamination and breakage are consequences of the embrittlement of the PE due to oxidation. Both demonstrate, that improving the clinical behaviour of UHMWPE means reduction of wear particles. The first can be achieved by cross-linking the second by the anti-oxidative stabiliser vitamin E. The highly cross-linked PE vitamys ® used for the isoelastic monobloc cup RM Pressfit (Mathys AG Bettlach, Bettlach, Switzerland) is mixed with 0.1% of synthetic vitamin E and is the first and only highly cross-linked PE used in total hip replacement that meets all requirements for the best grade UHMWPE in yield strength, ultimate tensile strength and elongation at break. METHODS AND MATERIAL. With the first implantation of RM Pressfit vitamys® a prospective multicentre study was started. So far 256 cases in 7 clinics from Europe and New Zealand are included. This report presents the first clinical experiences of one Swiss clinic from the multicentre study. Prospective data collection includes Harris Hip score (HHS), patient satisfaction and radiographic analysis. Clinical and radiographic follow-up is done after 6 weeks, 6, 12 and 24 months, and thereafter for long-term results. Standardized documentation of surgery and postoperative course is performed. RESULTS. 81 patients were included in the study. Mean age at implantation is 69 years. The indication was primary OA in 57% and secondary OA in 36%, the others were treated either for necrosis, fracture or hip dysplasia. 68% of the patients received a 36mm femoral head, 31% a 32mm and 1% a 28mm. Intraoperatively two minor complications occurred, one femur and one trochanter fissure. No complications occurred during implantation of the cup. Most of the cups (59%) were implanted with an inclination of 40°-50°, 30% with 35°-40°. There were no signs of early loosening and a good Harris Hip Score was achieved. DISCUSSION. The principals of this monobloc cup with its isoelastic property and the thin titanium coating is a proven concept. Ihle et al. (JBJS 2008) reported 91% survival rate with revision for aseptic loosening as endpoint after 20 years. They found an increase of cup revisions after 14 to 16 years after implantation due to osteolysis probably due to PE wear. At short term, we haven't encountered any problems related to the implantation of this cup. So far one patient in the entire multicentre study needed a stem revision after periprosthetic femur fracture. To prove the durability of this novel material a follow-up of 14 years and more will be required

The osteointegration of a new three-dimensional reticular titanium material, Trabecular Titanium™, was assessed using a bilateral cancellous (distal femur, proximal tibia) and cortical (tibia diaphysis) bone drill hole model in 18 sheep. TT is a novel Ti6Al4V material characterized by a high open porosity and composed of multi-planar regular hexagonal cells. Two 5.0 mm diameter, 12 mm long cylinders (TT1 & TT2) of two different porosities (TT1:650 μm, TT2:1250 μm) were tested and compared to two solid predicate 5.0 mm diameter, 12 mm long Ti cylinders (PT1 & PT2) coated with porous Ti (PT1: vacuum-plasma spray coating; PT2: inert-gas shielding arc spray coating). Each implant type was surgically implanted at 4 separate locations in each sheep (16 implants per sheep). Three timepoints of 4, 16 and 52 weeks (n=6 sheep per timepoint) were used. Bone-implant interface was analyzed ex vivo by the determination of: 1) the shear strength (SS) measured during a push out test, 2) the percentage of bone in-growth (%B) using histomorphometry, 3) the bone apposition rate using fluorochrome labelling analysis and 4) the bone-implant contact using backscattered scanning electron microscopy (SEM). An ANOVA with a Bonferroni Post hoc test were used to detect differences between tested and predicate implants. P values 0.05 were considered significant. At 4 weeks, 5 out of the 6 TT1 could be pushed out of the cortical bone (COB) samples. The remaining TT1 collapsed during testing. All TT1 could be pushed of the cancellous bone (CAB) samples. Four out of the 6 TT2 could be pushed out of CAB and of the COB samples. At 16 and 52 weeks, only one TT1 and one TT2 could be pushed out of the bone samples, the remaining implants collapsed during testing. All the PTs were successfully pushed out at all timepoints. The mean %B of PT1 and PT2 did not significantly increase over time. For both materials, the mean %B ranged between 1.7% and 4.4% at 4 weeks and between 5.7% and 6.5% at 52 weeks. The mean %B of TT1 significantly increased over time in both COB (10.2% at 4 weeks, 46.2% at 16 weeks, 50.5% at 52 weeks) and CAB (5.8%, 23.9%, 24.3%). Similarly, the mean %B of TT2 significantly increased over time in both COB (7.8%, 48.6%, 65%) and CAB (4.5%, 24.1%, 38.6%). Bone apposition rates for the TT implants remained superior to 2 μm/day for the entire duration of the study. SEM showed an intimate bone-implant contact for all implant types at all timepoints. At 16 and 52 weeks, histomorphometry revealed an extensive osteointegration of the TT specimens. Bone-implant interface strength was so high for the TT implants that they could not be pushed out of the bone samples. The results of this study would indicate that the TT implants provide a good scaffold for bone in-growth

Aims

This study explores data quality in operation type and fracture classification recorded as part of a large research study and a national audit with an independent review.

Aims

Periprosthetic femoral fractures (PFF) following total hip arthroplasty (THA) are devastating complications that are associated with functional limitations and increased overall mortality. Although cementless implants have been associated with an increased risk of PFF, the precise contribution of implant geometry and design on the risk of both intra-operative and post-operative PFF remains poorly investigated. A systematic review was performed to aggregate all of the PFF literature with specific attention to the femoral implant used.

Our aim in this pilot study was to evaluate the fixation of, the bone remodelling around, and the clinical outcome after surgery of a new, uncemented, fully hydroxyapatite-coated, collared and tapered femoral component, designed specifically for elderly patients with a fracture of the femoral neck.

We enrolled 50 patients, of at least 70 years of age, with an acute displaced fracture of the femoral neck in this prospective single-series study. They received a total hip replacement using the new component and were followed up regularly for two years.

Fixation was evaluated by radiostereometric analysis and bone remodelling by dual-energy x-ray absorptiometry. Hip function and the health-related quality of life were assessed using the Harris hip score and the EuroQol-5D.

Up to six weeks post-operatively there was a mean subsidence of 0.2 mm (−2.1 to +0.5) and a retroversion of a mean of 1.2° (−8.2° to +1.5°). No component migrated after three months. The patients had a continuous loss of peri-prosthetic bone which amounted to a mean of 16% (−49% to +10%) at two years. The mean Harris hip score was 82 (51 to 100) after two years.

The two-year results from this pilot study indicate that this new, uncemented femoral component can be used for elderly patients with osteoporotic fractures of the femoral neck.

Using data from the Norwegian Hip Fracture Register, 8639 cemented and 2477 uncemented primary hemiarthroplasties for displaced fractures of the femoral neck in patients aged > 70 years were included in a prospective observational study. A total of 218 re-operations were performed after cemented and 128 after uncemented procedures. Survival of the hemiarthroplasties was calculated using the Kaplan-Meier method and hazard rate ratios (HRR) for revision were calculated using Cox regression analyses. At five years the implant survival was 97% (95% confidence interval (CI) 97 to 97) for cemented and 91% (95% CI 87 to 94) for uncemented hemiarthroplasties. Uncemented hemiarthroplasties had a 2.1 times increased risk of revision compared with cemented prostheses (95% confidence interval 1.7 to 2.6, p < 0.001). The increased risk was mainly caused by revisions for peri-prosthetic fracture (HRR = 17), aseptic loosening (HRR = 17), haematoma formation (HRR = 5.3), superficial infection (HRR = 4.6) and dislocation (HRR = 1.8). More intra-operative complications, including intra-operative death, were reported for the cemented hemiarthroplasties. However, in a time-dependent analysis, the HRR for re-operation in both groups increased as follow-up increased.

This study showed that the risk for revision was higher for uncemented than for cemented hemiarthroplasties.

We undertook a prospective randomised controlled trial involving 400 patients with a displaced intracapsular fracture of the hip to determine whether there was any difference in outcome between treatment with a cemented Thompson hemiarthroplasty and an uncemented Austin-Moore prosthesis. The surviving patients were followed up for between two and five years by a nurse blinded to the type of prosthesis used.

The mean age of the patients was 83 years (61 to 104) and 308 (77%) were women. The degree of residual pain was less in those treated with a cemented prosthesis (p < 0.0001) three months after surgery. Regaining mobility was better in those treated with a cemented implant (p = 0.005) at six months after operation. No statistically significant difference was found between the two groups with regard to mortality, implant-related complications, re-operations or post-operative medical complications.

The use of a cemented Thompson hemiarthroplasty resulted in less pain and less deterioration in mobility than an uncemented Austin-Moore prosthesis with no increase in complications.