Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space. The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection.Aims
Methods
Despite the rising popularity of 1st carpometacarpal joint (CMCJ) arthrodesis as one of the surgical options for basilar thumb arthritis, the available literature on this is poor. This study aims to investigate post-operative pinch and grip strength following 1st CMCJ arthrodesis, at a minimum of 1 year follow-up. Complication rates, range of motion and patient reported scores were also evaluated. A retrospective cohort (2012–2020) was used, which included patients who had arthrodesis performed by the Hands surgeons at Counties Manukau DHB. In a 15 minute visit, we took the measurements using our standard dynamometer and pinch gauge, and collected three questionnaires [QuickDASH, PRWHE, PEM]. For analysis, we compared our results to the preoperative measures, contralateral hand, and to a previous study on a similar cohort looking at thumb strength following trapeziectomy.Introduction
Methods
Is Non-Weight-Bearing Necessary? (INWN) is a pragmatic multicentre randomised controlled trial comparing immediate protected weight-bearing (IWB) with non-weight-bearing cast immobilisation (NWB) following ankle fracture fixation (ORIF). This trial compares; functional outcomes, complication rates and performs an economic analysis to estimate cost-utility. IWB within 24hrs was compared to NWB, following ORIF of all types of unstable ankle fractures. Skeletally immature patients and tibial plafond fractures were excluded. Functional outcomes were assessed by the Olerud-Molander Ankle Score (OMAS) and RAND-36 Item Short Form Survey (SF-36) taken at regular follow-up intervals up to one year. A cost-utility analysis via decision tree modelling was performed to derive an incremental cost effectiveness ratio (ICER). A standard gamble health state valuation model utilising SF-36 scores was used to calculate Quality Adjusted Life Years (QALYs) for each arm. We recruited 160 patients (80 per arm), aged 15 to 94 years (M = 45.5), 54% female. Complication rates were similar in both groups. IWB demonstrated a consistently higher OMAS score, with significant values at 6 weeks (MD=10.4, p=0.005) and 3 months (MD 12.0, p=0.003). Standard gamble utility values demonstrated consistently higher values (a score of 1 equals perfect health) with IWB, significant at 3 months (Ẋ = 0.75 [IWB] / 0.69 [NWB], p=0.018). Cost-utility analysis demonstrated NWB is €798.02 more expensive and results in 0.04 fewer QALYs over 1 year. This results in an ICER of −€21,682.42/QALY. This negative ICER indicates cost savings of €21,682.42 for every QALY (25 patients = 1 QALY gain) gained implementing an IWB regime. IWB demonstrates a superior functional outcome, greater cost savings and similar complication rates, compared to NWB following ankle fracture fixation.
The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus NWB and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures. The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection, displacement of osteosynthesis, the full arc of ankle motion, RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay.Abstract
Objectives
Methods
Ankle fractures are common and affect young adults as well as the elderly. An unstable ankle fracture treatment typically involves surgical fixation, immobilisation, and modified weight-bearing for six weeks. Non-weight bearing (NWB) cast immobilisation periods were used to protect the soft tissue envelope and osteosynthesis. This can have implications on patient function and may reduce independence, mobility and return to work. Newer trends in earlier mobilisation compete with traditional NWB doctrine, and weak consensus exists as to the best postoperative strategy. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury). The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay.Introduction and Objective
Materials and Methods
In light of recent regulatory initiatives, medical devices now require additional clinical evidence to prove their safety and efficacy. At the same time, patients' own assessment of their devices' function and performance has gained in importance. The collection of these data allows for a more comprehensive picture of clinical outcomes and complications following total knee arthroplasty (TKA). These trends have led researchers to search for new methods of acquiring, interpreting and disseminating patient-reported outcome measurements (PROMs). The current study assesses the feasibility of a digital platform for collecting PROMs that was recently adapted for TKA patients. It sought to determine patient engagement, survey completion rates, and satisfaction with this platform. Eighty-two patients (mean age, 63.7 years, 59% females) scheduled for TKA were enrolled from one US and six UK sites between January 12, 2018 and April 30, 2018. Patients were supplied with a mobile application (app) that collects a variety of PROMs, including four domains based on the Patient-Reported Outcome Information System (PROMIS™): physical function, depression, pain interference and pain behavior. The platform electronically administers questionnaires using computer-adaptive tests (CATs), which reduce the burden on patients by tailoring follow-up questions to account for their previous answers. Satisfaction with the app was assessed in subset of patients who evaluated its ease-of-use (n=45), likelihood that they would recommend it to family/friends (n=35), and whether they successfully used the information it provided during their recovery (n=31). These scores were taken on a 1 to 10 (worst to best) scale. Patients demonstrated regular engagement with the platform, with 73% using the app at least once a week. Weekly engagement remained high throughout the seven-week post-operative period (Figure 1). There was a 69% completion rate of all PROMIS™ CAT surveys during the study. The four PROMIS™ CAT domains had similar survey completion rates (Figure 2). The subset of patients queried regarding their satisfaction with the app gave it favorable mean scores for ease-of-use (8.8), likelihood to recommend to a family member or friend (8.1), and their success at using its information to improve their recovery (7.4). Initial results support this digital platform's potential for successfully and efficiently collecting large volumes of PROMs. Patients reported high levels of engagement and satisfaction. For any figures or tables, please contact authors directly.
Direct skeletal attachment of prosthetic limbs, commonly known as osseointegration (“OI”), is being investigated by our team with the goal of safely introducing this technology into the United States for human use. OI technology allows for anchorage of prosthetic devices directly to bone using an intramedullary stem. For OI to be effective and secure, bone ingrowth and remodeling around the implant must be achieved. Physicians need an effective way to measure bone remodeling in order to make informed decisions on prescribed loading. This work describes methodology that was developed that utilizes computed tomography (CT) imaging as a tool for analyzing bone remodeling around an osseointegrated implant. A subject implanted with a new Percutaneous Osseointegrated Prosthesis (POP) (DJO Surgical, Austin, TX) had CTs taken of their residual femur at 6-weeks and 12-months post-op in a FDA Early Feasibility Study with Institutional Review Board approval. Three-dimensional models of the femur were created from dicom files of the CT slices using Mimics (v21.0, Materialise, Leuven, Belgium). Each scan was segmented into four objects: cortical bone, medullary cavity, total volume (cortical bone plus the medullary cavity) and endoprosthetic stem ( Following segmentation, models were uploaded to 3-Matic Research (v13.0, Materialise, Leuven, Blegium) in STL format for alignment to a common world coordinate system ( BML and STLs of the aligned medullary cavity and femur volume were entered into custom Matlab code designed to measure cortical and medullary morphology in transverse cross sections of the femur. Morphology data from 6-weeks and 12-month time points were compared in order to determine if bone remodeling around the POP implant could be detected using these methods.Introduction
Method
Derriford Hospital gained Major Trauma Centre (MTC) status in April 2012, this led to a significant increase in the trauma case load. Our aim was to review registrar exposure to theatre and clinic in the elective and trauma setting. This was then compared to audits performed pre-MTC status and shortly following MTC changes to see if training standards were being maintained. Improvements in registrar rota planning were made following the previous assessment of training. Training was assessed with respect to national recommendations for registrar training. Data was collected for 8 weeks in February and March 2014 for all 12 registrars, and cross-referenced with the on-call and daily rota. The data was divided into training and non -training registrars Elective exposure had improved in both theatres and clinic along with trauma theatre exposure whilst fracture clinic exposure had reduced since the previous audit. The reduction may be a result of the on-call registrar no longer being present in fracture clinic when on-call in compliance with MTC guidance. Rota management requires a fine balance between service and training commitments. Recent improvements to the management of the registrar rota appear to provide satisfactory training despite the pressures of MTC changes at Derriford Hospital.
This study reviewed all patients who received an EXOGEN Express bone stimulating device (BSD) to treat delayed union / non-union following operative treatment for a long bone fracture & evaluate if our results are comparable with the NICE guideline expectations. A retrospective review of records between December 2004 & January 2013 revealed 113 patients treated with a BSD. A total of 59 patients were eligible for analysis, (operative treatment for a long bone fracture with adjuvant EXOGEN BSD for non-union or delayed union). Twenty-one were open fractures. The BSD was applied at a mean of 264 days post-operatively. Thirty-five patients went on to have a 2nd operation before union was achieved. Forty-two patients went on to union following application of the BSD. Mean time to union was 293 days. Seventeen patients failed to unite by the end of the study. There were no adverse reactions to the EXOGEN BSD in this cohort. This study has shown that the use of an EXOGEN BSD is a safe, non-invasive method to successfully treat long bone non-unions following initial operative surgery, with potential cost savings (a potential saving of £48,888 to the hospital according to NICE estimations) compared to the standard re-operative management.
Impaction bone grafting for the reconstitution
of bone stock in revision hip surgery has been used for nearly 30 years.
Between 1995 and 2001 we used this technique in acetabular reconstruction,
in combination with a cemented component, in 304 hips in 292 patients
revised for aseptic loosening. The only additional supports used
were stainless steel meshes placed against the medial wall or laterally
around the acetabular rim to contain the graft. All Paprosky grades
of defect were included. Clinical and radiographic outcomes were
collected in surviving patients at a minimum of ten years after
the index operation. Mean follow-up was 12.4 years ( Cite this article:
A randomised controlled trial was conducted using a rabbit model of a complex contaminated extremity war wound. Compared to saline soaked gauze dressings Inadine (iodine) and Acticoat (nanocrystalline silver) had significantly lower levels of Molecular level analysis of the wound was conducted. Plasma cytokines of interest were assayed using ELISA and levels of expression of relevant tissue genes measured using PCR following RNA extraction. Appreciable levels of Interleukins 4 and 6 and Tumour Necrosis Factor-α were identified in plasma with significantly higher levels of IL-4 and TNFα detected in the Activon Tulle group. In tissue TNFα, Matrix metalloproteinase-3 and the ratio of Matrix metalloproteinase-9 to Tissue Inhibitor of Matrix metalloproteinase-1 were significantly higher in tissue injured limbs than the uninjured limbs with no significant differences between groups. Interpretation of these results is challenging. IL-4 has been associated with transition from pathological inflammation to repair and TNFα with impaired healing. However, Activon Tulle had significantly higher levels of
A 7-day randomised controlled pre-clinical trial utilising an existing extremity war wound model compared the efficacy of saline soaked gauze to commercially available dressings. The Flexor Carpi Ulnaris of anaesthetised rabbits was exposed to high-energy trauma using a computer-controlled jig and inoculated with 106 Clinical observations were made throughout the study. Haematology and plasma cytokines were analysed at intervals. Post-mortem histopathology included subjective semi-quantitative assessment of pathology severity using light microscopy to grade muscle injury and lymph node activation. Tissue samples were also examined using scanning electron microscopy (SEM). There were no bacteraemias, abscesses, purulent discharge or evidence of contralateral axillary lymph node activation. There were no significant differences in animal behaviour, weight change, maximum body temperature or white blood cell count elevation nor in pathology severity in muscle or lymph nodes (Kruskal-Wallis). There was no evidence of bacterial penetration or biofilm formation on SEM. Interleukin-4 and Tumour Necrosis Factor α levels were significantly higher in the ACTIVON TULLE group (1-way ANOVA p<0.05). This time-limited study demonstrated a statistically significant reduction in
A randomised controlled pre-clinical trial utilising an existing extremity war wound model compared the efficacy of saline soaked gauze to commercial dressings. The Flexor Carpi Ulnaris of anaesthetised New Zealand rabbits was exposed to high-energy trauma using computer-controlled jig and inoculated with 106 Clinical observations and haematology were performed during the study. Histopathological assessment of post-mortem muscle specimens included image analysis of digitally scanned haematoxylin and eosin stained tissue sections and subjective semi-quantitative assessment of pathology severity using light microscopy to grade muscle injury and lymph node activation. Tissue samples were also examined using scanning electron microscopy to determine the presence of bacteria and biofilm formation within the injured muscle. Non-parametric data were compared using Kruskal-Wallis. There were no bacteraemias, significantly raised white cell counts, abscesses, purulent discharge or evidence of contralateral axillary lymph node activation. All injured muscle specimens showed evidence of haemorrhage, inflammatory cell infiltration and fibrosis. All ipsilateral axillary lymph nodes were activated. There were no significant differences in the amount of muscle loss, size of the activated lymph nodes or in subjective semi-quantitative scoring criteria for muscle injury or lymph node activation. There was no evidence of bacterial penetration or biofilm formation. This study demonstrated statistically significant reductions in
Doubt has been cast over the accuracy of dermatome charts. This study investigated a large group of patients with known lumbar nerve root compression (NRC), and identified whether their radicular pain corresponded with the predicted distribution on a dermatome chart. The study included 209 patients that presented with lumbar radiculopathy. 106 were confirmed as L5 NRC and 103 as S1 NRC, by MRI. Each patient used an interactive computer assessment program to record their pain on a body map image. The coordinates were then used to compare the sensory distribution to a standard dermatome chart.Background
Methods
Idiopathic scoliosis is a lateral curvature of the spine >10° as measured on a frontal plane radiograph by the Cobb angle. Important variables in assessing the risk of curve progression include a young age at presentation, female sex, a large amount of growth remaining, the rate of growth, the curve magnitude, and the curve location. Curves >20° have an inherently low risk of progression. Surgery is indicated for curves >50° or rapidly progressing curves. The timing of surgery is paramount in order to intervene in cases where rapid progression is evident to prevent further deterioration. There is a greater likelihood for more complex surgery to be required in major curves. At present, there are severe restrictions on resources to cater for patients with scoliosis. As a result, patients spend excessive periods on waiting lists prior to having their procedure. The aim of this study is to analyse the progression of curves of patients while on the waiting list and assess the cost implications of curve deterioration. A retrospective analysis of 40 cases of adolescent idiopathic scoliosis performed from between 2007-2010 was carried out. All radiographs at the time of being placed on the waiting list and the time of admission were reviewed to assess the Cobb angle. The radiographs were analysed independently by three spinal surgeons to determine what level of surgical intervention they would recommend at each time point. The final procedure performed was also recorded. A cost analysis was carried out of all of the expenses that are incurred as part of scoliosis surgery, including length of hospital stay, intensive care admission, spinal monitoring, implant cost, and the requirement for multiple procedures.Introduction
Methods
We describe two recent cases of intraosseous (IO) access resulting in amputation in critically ill infants and make contemporary recommendations on the safe practice of this technique. This is a retrospective case series of two children transferred from peripheral hospitals to our unit. One child (5 months) was resuscitated after cardiorespiratory decompensation due to diaphragmatic hernia. The other child (18 months) deteriorated during presentation with purpura fulminans two days after a scald injury. Both children underwent emergent bilateral tibial IO access using power driven needle systems. Initial resuscitation included large volumes of 0.9% normal saline. One child received doses of adrenaline and 8.4% sodium bicarbonate, whole blood and an initial dopamine infusion; the other received 8.4% sodium bicarbonate, 10% calcium gluconate and whole blood. Total infused volumes were 400mL and 730 ml respectively. Progressive lower limb tension became evident in both children after 12 hours; bilateral posterior tibial fractures were noted in one child. Ultimately, both children underwent surgical fasciotomy, but extensive necrosis necessitated unilateral below knee amputation at days 12 and 13 respectively.Purpose
Methods/results
Uncontrolled deep sepsis in the diabetic foot often leads to below knee amputation (BKA). However, for deep sepsis in the forefoot, a transmetatarsal amputation can be curative while preserving the native ankle and hindfoot and allowing mobility without a prosthesis. We critically examined the outcome of transmetatarsal amputation in our diabetic patients with forefoot ulceration and proven osteomyelitis. Data were collected prospectively at the multidisciplinary diabetic foot clinic. We recorded demographic details, duration of diabetes, comorbidities, nature of ulceration, radiological findings, Texas wound score and details of surgery. Patients were followed up regularly in the diabetes clinic. Medical records were reviewed and complications recorded.Introduction
Materials and Methods
An osteoporosis screening service for patients presenting to the fracture clinic in Derriford Hospital Plymouth was established in February 2009. We report on the findings of the first year of patients referred for dual energy X-ray absorptiometry (DEXA) screening. Patients between 50 and 75 years of age, who sustained a fracture as a result of a fall from standing height or less, who had not previously had a DEXA scan within the last two years, were referred. Patients outside these age limits with other risk factors for osteoporosis were scanned at the discretion of the fracture clinic consultant. Of those patients who were referred, 96% subsequently attended for a scan timed to coincide with their scheduled fracture clinic follow-up appointment. 402 patients were scanned in total, of which 351 were female and 51 were male. The mean patient age was 65. The results for women were as follows: 21% normal, 45% osteopenic, 34% osteoporotic. The results for men were: 19% normal, 43% osteopenic, 38% osteoporotic. The scan results were forwarded to the patient's general practitioner for action as deemed necessary. These findings support the establishment of this screening service for both men and women.
The addition of Extended Scope Practitioner (ESP) clinics was proposed to review new Foot and Ankle referrals, to reduce time consultants spend in clinic and free them up for theatre. There would be a cost benefit to the Primary Care Trusts (PCT), a clinic appointment with the consultants cost's around £140 and ESPs around £70. We prospectively collected data from the ESP clinics for two months in 2009. We looked at the number of patients referred on to the consultants and how many of these needed surgery. During this period one hundred and forty one patients were booked into ESP clinics, forty three were referred to the consultants, ninety one were managed by the ESPs and seven patients failed to attend. The estimated saving to the PCT during the 2 month period was £6860 which would be £41,160 over a year. Twenty nine of the patients referred to the consultants required surgery giving a 74% conversion rate. The use of ESPs in Foot and Ankle Clinic reduces the number of new referrals seen by consultants, therefore being cost effective to the PCTs. This also increased the consultant's surgical conversion rate producing a more efficient service.
Periprosthetic fractures after total hip arthroplasty are challenging, with potential difficulties associated not only with the fracture but also with implant loosening and bone loss. The incidence of periprosthetic fractures is gradually increasing. We undertook this study to evaluate the periprosthetic fractures presenting to our unit in terms of mechanism of failure, classification and treatment. Charts of patients with periprosthetic fractures presenting within the past six years were retrospectively analysed for demographic and injury details and corresponding radiographs were reviewed to classify the fracture and follow treatment. 45 fractures were identified, with an average age of 78.3 years. The male to female ratio was 5:4. Only 4 fractures occurred in revision prostheses. Two fractures were intraoperative. The Vancouver system was used to classify the fractures, which can also form a basis for treatment. Three fractures of Vancouver type A were managed conservatively without complication. Thirteen fractures were Vancouver type B1, 12 of which underwent internal fixation, mostly plate osteosynthesis; two of these subsequently failed. Recent fractures have been stabilised using locking plates, with no recorded failures. Fifteen fractures were Vancouver type B2, 11 of which were greater than 5 years post arthroplasty. Most underwent revision of the femoral component. Five of these patients had reported pain for some time preceding fracture. Seven fractures were Vancouver type B3, all occurring greater than 7 years post arthroplasty. Most underwent femoral revision. Seven fractures were Vancouver type C, all underwent plate fixation without failure. Although there is variability within the group studied, this series demonstrates gradual standardisation of treatment with use of locking plates and a preferred long revision femoral stem. The reports of pain preceding fracture in a proportion of the Vancouver B2 group prompts greater postoperative surveillance in patients with early signs of femoral loosening.