Introduction. It is well known that blood flow is a critical key component of fracture repair. Previously, we demonstrated that transcutaneous application of CO2 increased blood flow in the human body. To date, there has been no report investigating the effect of the carbonated therapy on fracture repair. Hypothesis. We hypothesized that the transcutaneous application of CO2 to fracture site would accelerate fracture repair. Materials & Methods. A closed femoral shaft fracture was produced in rats. Transcutaneous CO2 absorption enhancing hydrogel and CO2 adaptor that sealed the body surface and retained the gas inside were used for CO2 treatment. Rats without CO2 treatment served as control. Radiographic, biomechanical and histological analysis was performed to assess the fracture repair. Gene expression of chondrogenic, hypertrophic, osteogenic and angiogenic markers was measured by real-time PCR at 1, 2, 3, and 4 weeks post-fracture. Results. Union rate, biomechanical properties, and gene expression of chondrogenic, hypertrophic, osteogenic and angiogenic markers was significantly higher in CO2 group compared to control group. Histological evaluation demonstrated that enchondral ossification was promoted in CO2 group. Discussion & Conclusions. Our study indicate that transcutaneous application of CO2 accelerates fracture repair via acceleration of endochondral ossification and vascularization, and may become a novel and useful therapy for promoting fracture repair

Aims. The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis. Methods. In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years’ follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded. Results. The Q-TFA scores at two, five, seven, and ten years showed significantly more prosthetic use, better mobility, fewer problems, and an improved global situation, compared with baseline. The survival rate of the osseointegrated implant part (the fixture) was 89% and 72% after seven and 15 years, respectively. A total of 61 patients (55%) had mechanical complications (mean 3.3 (SD 5.76)), resulting in exchange of the percutaneous implant parts. There was a positive relationship between a higher activity grade and the number of mechanical complications. Conclusion. Compared with before treatment, the patient-reported outcome was significantly better and remained so over time. Although osseointegration and the ability to transfer loads over a 15-year period have been demonstrated, a large number of mechanical failures in the external implant parts were found. Since these were related to higher activity, restrictions in activity and improvements to the mechanical properties of the implant system are required. Cite this article: Bone Joint J 2020;102-B(1):55–63

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

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

Objectives

The monitoring of fracture healing is a complex process. Typically, successive radiographs are performed and an emerging calcification of the fracture area is evaluated. The aim of this study was to investigate whether different bone healing patterns can be distinguished using a telemetric instrumented femoral internal plate fixator.

Objectives

A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults.

We undertook a trial on 60 patients with AO 31A2 fractures of the hip who were randomised after stabilisation of the fracture into two equal groups, one of which received post-operative treatment using a non-invasive interactive neurostimulation device and the other with a sham device. All other aspects of their rehabilitation were the same. The treatment was continued for ten days after operation.

Outcome measurements included the use of a visual analogue scale for pain, the brief pain inventory and Ketorolac for post-operative control of pain, and an overall assessment of outcome by the surgeon. There were significantly better results for the patients receiving treatment by active electrical stimulation (repeated measures analysis of variance, p < 0.001). The findings of this pilot trial justify a larger study to determine if these results are more generally applicable.

Between 2000 and 2006 we performed salvage tibiotalar arthrodesis in 17 diabetic patients (17 ankles) with grossly unstable ankles caused by bimalleolar fractures complicated by Charcot neuro-arthropathy. There were ten women and seven men with a mean age of 61.6 years (57 to 69). A crossed-screw technique was used. Two screws were used in eight patients and three screws in nine. Additional graft from the malleoli was used in all patients. The mean follow-up was 26 months (12 to 48) and the mean time to union was 5.8 months (4 to 8). A stable ankle was achieved in 14 patients (82.4%), nine of whom had bony fusion and five had a stiff fibrous union. The results were significantly better in underweight patients, in those in whom surgery had been performed three to six months after the onset of acute Charcot arthropathy, in those who had received anti-resorptive medication during the acute stage, in those without extensive peripheral neuropathy, and in those with adequate peripheral oxygen saturation (> 95%). The arthrodesis failed because of avascular necrosis of the talus in only three patients (17.6%), who developed grossly unstable, ulcerated hindfeet, and required below-knee amputation.

In an interdisciplinary project involving electronic engineers and clinicians, a telemetric system was developed to measure the bending load in a titanium internal femoral fixator. As this was a new device, the main question posed was: what clinically relevant information could be drawn from its application? As a first clinical investigation, 27 patients (24 men, three women) with a mean age of 38.4 years (19 to 66) with femoral nonunions were treated using the system. The mean duration of the nonunion was 15.4 months (5 to 69). The elasticity of the plate-callus system was measured telemetrically until union. Conventional radiographs and a CT scan at 12 weeks were performed routinely, and healing was staged according to the CT scans. All nonunions healed at a mean of 21.5 weeks (13 to 37). Well before any radiological signs of healing could be detected, a substantial decrease in elasticity was recorded. The relative elasticity decreased to 50% at a mean of 7.8 weeks (3.5 to 13) and to 10% at a mean of 19.3 weeks (4.5 to 37). At 12 weeks the mean relative elasticity was 28.1% (0% to 56%). The relative elasticity was significantly different between the different healing stages as determined by the CT scans.

Incorporating load measuring electronics into implants is a promising option for the assessment of bone healing. Future application might lead to a reduction in the need for exposure to ionising radiation to monitor fracture healing.

In a randomised prospective study, 20 patients with intra-articular fractures of the distal radius underwent arthroscopically- and fluoroscopically-assisted reduction and external fixation plus percutaneous pinning. Another group of 20 patients with the same fracture characteristics underwent fluoroscopically-assisted reduction alone and external fixation plus percutaneous pinning. The patients were evaluated clinically and radiologically at follow-up of 24 months. The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and modified Mayo wrist score were used at 3, 9, 12 and 24 months postoperatively. In the arthroscopically- and fluoroscopically-assisted group, triangular fibrocartilage complex tears were found in 12 patients (60%), complete or incomplete scapholunate ligament tears in nine (45%), and lunotriquetral ligament tears in four (20%). They were treated either arthroscopically or by open operation. Patients who underwent arthroscopically- and fluoroscopically-assisted treatment had significantly better supination, extension and flexion at all time points than those who had fluoroscopically-assisted surgery. The mean DASH scores were similar for both groups at 24 months, whereas the difference in the mean modified Mayo wrist scores remained statistically significant.

Although the groups are small, it is clear that the addition of arthroscopy to the fluoroscopically-assisted treatment of intra-articular distal radius fractures improves the outcome. Better treatment of associated intra-articular injuries might also have been a reason for the improved outcome.