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
Frozen shoulder is a common, painful condition that results in impairment of function. Corticosteroid injections are commonly used for frozen shoulder and can be given as glenohumeral joint (GHJ) injection or suprascapular nerve block (SSNB). Both injection types have been shown to significantly improve shoulder pain and range of motion. It is not currently known which is superior in terms of relieving patients’ symptoms. This is the protocol for a randomized clinical trial to investigate the clinical effectiveness of corticosteroid injection given as either a GHJ injection or SSNB. The Therapeutic Injections For Frozen Shoulder (TIFFS) study is a single centre, parallel, two-arm, randomized clinical trial. Participants will be allocated on a 1:1 basis to either a GHJ corticosteroid injection or SSNB. Participants in both trial arms will then receive physiotherapy as normal for frozen shoulder. The primary analysis will compare the Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include OSS at six and 12 months, range of shoulder movement at three months, and Numeric Pain Rating Scale, abbreviated Disabilities of Arm, Shoulder and Hand score, and EuroQol five-level five-dimension health index at three months, six months, and one year after injection. A minimum of 40 patients will be recruited to obtain 80% power to detect a minimally important difference of ten points on the OSS between the groups at three months after injection. The study is registered under ClinicalTrials.gov with the identifier NCT04965376.Aims
Methods
Additive manufacturing has led to numerous innovations in orthopaedic surgery: surgical guides; surface coatings/textures; and custom implants. Most contemporary implants are made from titanium alloy (Ti-6Al-4V). Despite being widely available industrially and clinically, there is little published information on the performance of this 3D printed material for orthopaedic devices with respect to regulatory approval. The aim of this study was to document the mechanical, chemical and biological properties of selective laser sintering (SLS) manufactured specimens following medical device (TOKA®, 3D Metal Printing LTD, UK) submission and review by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). All specimens were additively manufactured in Ti-6Al-4V ELI (Renishaw plc, UK). Mechanical tests were performed according to ISO6892-1, ISO9585 and ISO12107 for tensile (n=10), bending (n=3) and fatigue (n=16) respectively (University of Bath, UK). Appropriate chemical characterisation and biological tests were selected according to recommendations in ISO10993 and conducted by external laboratories (Wickham Labs, UK; Lucideon, UK; Edwards Analytical, UK) in adherence with Good Lab Practise guidelines. A toxicological review was conducted on the findings (Bibra, UK).Abstract
Objectives
Methods
Pain of lumbar facet-joint origin is a common cause of low back pain in adults, and may lead to chronic pain and disability. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain. The study's objective was to assess the feasibility of carrying out a definitive study to evaluate the clinical- and cost-effectiveness of lumbar facet-joint injections compared to a sham procedure. This was a blinded parallel two-arm pilot randomised controlled trial. Adult patients referred to the pain and orthopaedic clinics at Barts Health NHS Trust with non-specific low back pain of at least three months' duration were considered for inclusion. Participants who had a positive result following diagnostic single medial branch nerve blocks were randomised to receive either intra-articular lumbar facet-joint injections with steroid or a sham procedure. All participants were invited to attend a combined physical and psychological programme. Questionnaires were used to assess a range of pain and disability-related issues. Healthcare utilisation and cost data were also assessed. Of 628 participants screened for eligibility, 9 were randomised to receive the study intervention and 8 participants completed the study.Purposes of the study and background
Summary of methods and results
Computer-aided surgical systems commonly use preoperative CT scans when performing pelvic osteotomies for intraoperative navigation. These systems have the potential to improve the safety and accuracy of pelvic osteotomies, however, exposing the patient to radiation is a significant drawback. In order to reduce radiation exposure, we propose a new smooth extrapolation method leveraging a partial pelvis CT and a statistical shape model (SSM) of the full pelvis in order to estimate a patient's complete pelvis. A SSM of normal, complete, female pelvis anatomy was created and evaluated from 42 subjects. A leave-one-out test was performed to characterise the inherent generalisation capability of the SSM. An additional leave-one-out test was conducted to measure performance of the smooth extrapolation method and an existing “cut-and-paste” extrapolation method. Unknown anatomy was simulated by keeping the axial slices of the patient's acetabulum intact and varying the amount of the superior iliac crest retained; from 0% to 15% of the total pelvis extent. The smooth technique showed an average improvement over the cut-and-paste method of 1.31 mm and 3.61 mm, in RMS and maximum surface error, respectively. With 5% of the iliac crest retained, the smoothly estimated surface had an RMS surface error of 2.21 mm, an improvement of 1.25 mm when retaining none of the iliac crest. This anatomical estimation method creates the possibility of a patient and surgeon benefiting from the use of a CAS system and simultaneously reducing the patient's radiation exposure.
Anterior Cruciate Ligament (ACL) rupture is one of the commonest injuries in sports medicine. However, the rates of the reported graft re-rupture range from 2–10%, leading to around 3000 to 10000 revision ACL reconstructions in United States per annum. Inaccurate tunnel positions are considered to be one of the commonest reasons leading to failure and subsequent revision surgery. Additionally, there remains no consensus of the optimal position for ACL reconstructions. The positions of the bone tunnels in patients receiving ACL reconstruction are traditionally assessed using X-rays. It is well known that conventional X-ray is not a precise tool in assessing tunnel positions. Thus, there is a recent trend in using three-dimensional (3D) CT. However, routine CT carries a major disadvantage in terms of significant radiation hazard. In addition, it is both inconvenient and expensive to use CT as a regular assessment tools during the follow-up. The goal of the present work is to We propose two 2D-3D registration methods. One is a contour-based method that uses pure geometric information. Most methods in this category accomplish the registration by extracting contours in X-rays, establishing their correspondences on the 3D model, and calculating the registration parameters. Unlike these methods, which need point-to-point correspondences, The second method takes into account both the geometric shape of the object and the intensity property (intensity changes) of the image, where the intensity changes can be detected via image gradients. The use of gradient is based on the interpretation that two images are considered similar, if intensity changes occur at the same locations. The angles between the image gradients and the projected surface normals were used as a distance measure. The summation of the measures for all projected model points gives us the gradient term, which we multiply the contour-based measurement. Multiplication is preferred over addition because addition of the terms would require both terms to be normalised. To evaluate the feasibility of our methods, a simulation study was conducted using Digitally Reconstructed Radiographs (DRR) of a sawbone underwent a single-bundle ACL reconstruction performed by an experienced orthopedic surgeon. The real position of the bone tunnel entry point was obtained using the CT images, which were acquired using a custom-made well-calibrated cone-beam CT. The knee model was built by downsampling and smoothing the high-resolution CT reconstructions. It is important in our experiments to make the model different from the original reconstruction since this simulates the condition in which patient's CT is unavailable. Two DRRs generated from approximately anteroposterior and lateral viewpoints were used. For each DRR, 50 trials of 2D-3D registration were carried out for the femoral part using 50 different initialisations, which were randomly selected from the values independently and uniformly distributed within ±10 degrees and ±10 mm of the ground-truth. Compared with the ground-truth established using the CT images, our single image contour-based method achieved accurate estimations in rotations and in-plane translations, which were (−0.67±1.38, −0.98±0.84, −0.42±0.71) degrees and (0.11±0.26, −0.06±1.20) mm for the anteroposterior image, and (−0.78±0.76, −0.37±0.87, 0.70±0.88) degrees and (−0.14±0.22, 0.31±0.71) mm for the lateral one, respectively. The same experiments were also performed using the second method. However, it did not produce desirable results in our experiments. The tunnel entry point was then calculated using the averaged registration result of our contour-based method. For the 2D-3D registration, the estimated off-plane translations showed relatively low accuracy. It is well known that the depth can be difficult to be accurately estimated using one single image. As the result showed, the accuracy in rotations and in-plane translations is more important for ACL tunnel position estimation in our framework. As for the image gradient, it is too sensitive to the small perturbation caused by image noises. A more robust way of integrating the gradient information into our contour-based method is required. We propose a novel approach for estimating the 3D position of bone tunnels in ACL reconstruction using two post-operative X-rays. It was tested in a sawbone study using DRRs.
Giant cell tumour of bone (GCTB) is an expansile osteolytic tumour of bone which contains numerous osteoclast-like giant cells. GCTB is a locally aggressive tumour which can cause extensive bone destruction that can be difficult to control surgically, up to 35% of cases recurring after simple curettage. Bisphosphonates are anti-resorptive agents that have proved effective in the treatment of a number of osteolytic conditions. In keeping with its known effect on osteoclasts, we found that the aminobisphosphonate zoledronate abolished in vitro lacunar resorption in cultures of osteoclasts isolated from GCTB. The effect of zoledronate and other bisphosphonates on 15 cases of recurrent primary GCTB, four of which had metastasised to the lung, was assessed clinically. Most recurrent tumours did not exhibit progressive enlargement and, in some cases, both primary and metastatic GCTBs showed a degree of radiological improvement following treatment However, tumours did not diminish in size and, in some cases, no apparent treatment effect was noted. Our findings provide in vitro evidence for the use of bisphosphonates to inhibit the progressive osteolysis associated with GCTB. In vivo, these agents produced a degree of clinical and radiological improvement in some cases. This study reports results from three European centres where bisphosphonates are being used to treat recurrent GCTB and highlights the fact that these centres are all employing different clinical indications and different regimes of bisphosphonate treatment. Bisphosphonates have significant side effects and indications for treatment and standardisation of drug type and dosage regimes (and measurement of agreed outcome measures to determine treatment efficacy) should be established before these agents are included as part of a treatment protocol to control GCTB tumour growth and osteolysis.
In relation to the conduct of this study, one or more of the authors has received, or is likely to receive direct material benefits.