Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial. DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment.Aims
Methods
When the present study was initiated, we changed the treatment for late-detected developmental dislocation of the hip (DDH) from several weeks of skin traction to markedly shorter traction time. The aim of this prospective study was to evaluate this change, with special emphasis on the rate of stable closed reduction according to patient age, the development of the acetabulum, and the outcome at skeletal maturity. From 1996 to 2005, 49 children (52 hips) were treated for late-detected DDH. Their mean age was 13.3 months (3 to 33) at reduction. Prereduction skin traction was used for a mean of 11 days (0 to 27). Gentle closed reduction under general anaesthesia was attempted in all the hips. Concurrent pelvic osteotomy was not performed. The hips were evaluated at one, three and five years after reduction, at age eight to ten years, and at skeletal maturity. Mean age at the last follow-up was 15.7 years (13 to 21).Aims
Methods
The direct posterior approach with subperiosteal dissection of the paraspinal muscles from the vertebrae is considered to be the standard approach for the surgical treatment of adolescent idiopathic scoliosis (AIS). We investigated whether or not a minimally-invasive surgery (MIS) technique could offer improved results. Consecutive AIS patients treated with an MIS technique at two tertiary centres from June 2013 to March 2016 were retrospectively included. Preoperative patient deformity characteristics, perioperative parameters, power of deformity correction, and complications were studied. A total of 93 patients were included. The outcome of the first 25 patients and the latter 68 were compared as part of our safety analysis to examine the effect of the learning curve.Aims
Methods
The primary aim of this study was to evaluate the efficacy of distension arthrography in the treatment of adhesive capsulitis of the shoulder. The secondary aim was to assess which patient and procedural factors predicted the recurrence of symptoms after the procedure. All patients referred to our shoulder clinic over a ten-year period, between 2008 and 2018, with a clinical diagnosis of capsulitis and symptoms persisting for more than six months, were offered treatment with a distension arthrogram. All procedures were performed by one of five musculoskeletal radiologists, with a combination of steroid, local anaesthetic, and a distention volume of 10 ml, 30 ml, or 50 ml. Patient demographics, procedural details, recurrence of symptoms, and the need for further intervention were evaluated.Aims
Methods
The aim of this study was to assess whether supine flexibility predicts the likelihood of curve progression in patients with adolescent idiopathic scoliosis (AIS) undergoing brace treatment. This was a retrospective analysis of patients with AIS prescribed with an underarm brace between September 2008 to April 2013 and followed up until 18 years of age or required surgery. Patients with structural proximal curves that preclude underarm bracing, those who were lost to follow-up, and those who had poor compliance to bracing (<16 hours a day) were excluded. The major curve Cobb angle, curve type, and location were measured on the pre-brace standing posteroanterior (PA) radiograph, supine whole spine radiograph, initial in-brace standing PA radiograph, and the post-brace weaning standing PA radiograph. Validation of the previous in-brace Cobb angle regression model was performed. The outcome of curve progression post-bracing was tested using a logistic regression model. The supine flexibility cut-off for curve progression was analyzed with receiver operating characteristic curve.Aims
Methods
The primary aim of this study was to describe a baseline comparison of early knee-specific functional outcomes following revision total knee arthroplasty (TKA) using metaphyseal sleeves with a matched cohort of patients undergoing primary TKA. The secondary aim was to compare incidence of complications and length of stay (LOS) between the two groups. Patients undergoing revision TKA for all diagnoses between 2009 and 2016 had patient-reported outcome measures (PROMs) collected prospectively. PROMs consisted of the American Knee Society Score (AKSS) and Short-Form 12 (SF-12). The study cohort was identified retrospectively and demographics were collected. The cohort was matched to a control group of patients undergoing primary TKA.Introduction
Methods
Although internal hemipelvectomy is associated with a high incidence of morbidity, especially wound complications, few studies have examined rates of wound complications in these patients or have identified factors associated with the consequences. The present study aimed to: 1) determine the rate of wound and other complications requiring surgery after internal hemipelvectomy; and 2) identify factors that affect the rate of wound complications and can be used to stratify patients by risk of wound complications. The medical records of 123 patients undergoing internal hemipelvectomy were retrospectively reviewed, with a focus on both overall complications and wound complications. Logistic regression analyses were performed to examine the association between host, tumour, and surgical factors and rates of postoperative wound complications.Aims
Methods
To validate the Sydney Hamstring Origin Rupture Evaluation (SHORE), a hamstring-specific clinical assessment tool to evaluate patient outcomes following surgical treatment. A prospective study of 70 unilateral hamstring surgical repairs, with a mean age of 47.3 years (15 to 73). Patients completed the SHORE preoperatively and at six months post-surgery, and then completed both the SHORE and Perth Hamstring Assessment Tool (PHAT) at three years post-surgery. The SHORE questionnaire was validated through the evaluation of its psychometric properties, including; internal consistency, reproducibility, reliability, sensitivity to change, and ceiling effect. Construct validity was assessed using Pearson’s correlation analysis to examine the strength of association between the SHORE and the PHAT.Aims
Methods
The aim of the Scaphoid Magnetic Resonance Imaging in Trauma (SMaRT) trial was to evaluate the clinical and cost implications of using immediate MRI in the acute management of patients with a suspected fracture of the scaphoid with negative radiographs. Patients who presented to the emergency department (ED) with a suspected fracture of the scaphoid and negative radiographs were randomized to a control group, who did not undergo further imaging in the ED, or an intervention group, who had an MRI of the wrist as an additional test during the initial ED attendance. Most participants were male (52% control, 61% intervention), with a mean age of 36.2 years (18 to 73) in the control group and 38.2 years (20 to 71) in the intervention group. The primary outcome was total cost impact at three months post-recruitment. Secondary outcomes included total costs at six months, the assessment of clinical findings, diagnostic accuracy, and the participants’ self-reported level of satisfaction. Differences in cost were estimated using generalized linear models with gamma errors.Aims
Patients and Methods
It is not known whether change in patient-reported outcome measures (PROMs) over time can be predicted by factors present at surgery, or early follow-up. The aim of this study was to identify factors associated with changes in PROM status between two-year evaluation and medium-term follow-up. Patients undergoing Birmingham Hip Resurfacing completed the Veteran’s Rand 36 (VR-36), modified Harris Hip Score (mHHS), Tegner Activity Score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at two years and a minimum of three years. A change in score was assessed against minimal clinically important difference (MCID) and patient-acceptable symptom state (PASS) thresholds. Binary logistic regression was used to assess the relationship between patient factors and deterioration in PASS status between follow-ups.Aims
Patients and Methods
We inserted an electrode up the femoral neck into the femoral head of ten patients undergoing a metal-on-metal hip resurfacing arthroplasty through a posterior surgical approach and measured the oxygen concentration during the operation. In every patient the blood flow was compromised during surgery, but the extent varied. In three patients, the oxygen concentration was zero at the end of the procedure. The surgical approach caused a mean 60% drop (p <
0.005) in oxygen concentration while component insertion led to a further 20% drop (p <
0.04). The oxygen concentration did not improve significantly on wound closure. This study demonstrates that during hip resurfacing arthroplasty,
The aim of this study was to assess the functional gain achieved following hip resurfacing arthroplasty (HRA). A total of 28 patients (23 male, five female; mean age, 56 years (25 to 73)) awaiting Birmingham HRA volunteered for this prospective gait study, with an age-matched control group of 26 healthy adults (16 male, ten female; mean age, 56 years (33 to 84)). The Oxford Hip Score (OHS) and gait analysis using an instrumented treadmill were used preoperatively and more than two years postoperatively to measure the functional change attributable to the intervention.Aims
Patients and Methods