Objectives. The annual incidence of hip fracture is 620 000 in the European Union. The cost of this clinical problem has been estimated at 1.75 million disability-adjusted life years lost, equating to 1.4% of the total healthcare burden in established market economies. Recent guidance from The National Institute for Health and Clinical Excellence (NICE) states that research into the clinical and cost effectiveness of total hip arthroplasty (THA) as a treatment for hip fracture is a priority. We asked the question: can a trial investigating THA for hip fracture currently be delivered in the NHS?. Methods. We performed a contemporaneous process evaluation that provides a context for the interpretation of the findings of WHiTE Two – a randomised study of THA for hip fracture. We developed a mixed methods approach to situate the trial centre within the context of wider United Kingdom clinical practice. We focused on fidelity, implementation, acceptability and feasibility of both the trial processes and interventions to stakeholder groups, such as healthcare providers and patients. Results. We have shown that patients are willing to participate in this type of research and that surgeons value being part of a team that has a strong research ethos. However, surgical practice does not currently reflect NICE guidance. Current models of service delivery for hip fractures are unlikely to be able to provide timely total hip arthroplasty for suitable patients. Conclusions. Further observational research should be conducted to define the population of interest before future interventional studies are performed. Cite this article: C. Huxley, J. Achten, M. L. Costa, F. Griffiths, X. L. Griffin. A process evaluation of the WHiTE Two trial comparing total hip arthroplasty with and without dual mobility component in the treatment of displaced intracapsular fractures of the proximal femur: Can a trial investigating total hip arthroplasty for hip fracture be delivered in the NHS? Bone Joint Res 2016;5:444–452. DOI: 10.1302/2046-3758.510.BJR-2015-0008.R1

Aims

Although absorbable sutures for the repair of acute Achilles tendon rupture (ATR) have been attracting attention, the rationale for their use remains insufficient. This study prospectively compared the outcomes of absorbable and nonabsorbable sutures for the repair of acute ATR.

Aims

In metal-on-polyethylene (MoP) total hip arthroplasty (THA), large metal femoral heads have been used to increase stability and reduce the risk of dislocation. The increased size of the femoral head can, however, lead to increased taper corrosion, with the release of metal ions and adverse reactions. The aim of this study was to investigate the relationship between the size of the femoral head and the levels of metal ions in the blood in these patients.

Aims. The aim of this study was to investigate the hypothesis that a single dose of tranexamic acid (TXA) would reduce blood loss and transfusion rates in elderly patients undergoing surgery for a subcapital or intertrochanteric (IT) fracture of the hip. Methods. In this single-centre, randomized controlled trial, elderly patients undergoing surgery for a hip fracture, either hemiarthroplasty for a subcapital fracture or intramedullary nailing for an IT fracture, were screened for inclusion. Patients were randomly allocated to a study group using a sealed envelope. The TXA group consisted of 77 patients, (35 with a subcapital fracture and 42 with an IT fracture), and the control group consisted of 88 patients (29 with a subcapital fracture and 59 with an IT fracture). One dose of 15 mg/kg of intravenous (IV) TXA diluted in 100 ml normal saline (NS,) or one dose of IV placebo 100 ml NS were administered before the incision was made. The haemoglobin (Hb) concentration was measured before surgery and daily until the fourth postoperative day. The primary outcomes were the total blood loss and the rate of transfusion from the time of surgery to the fourth postoperative day. Results. Homogeneity with respect to baseline characteristics was ensured between groups. The mean total blood loss was significantly lower in patients who received TXA (902.4 ml (-279.9 to 2,156.9) vs 1,226.3 ml (-269.7 to 3,429.7); p = 0.003), while the likelihood of requiring a transfusion of at least one unit of red blood cells was reduced by 22%. Subgroup analysis showed that these differences were larger in patients who had an IT fracture compared with those who had a subcapital fracture. Conclusion. Elderly patients who undergo intramedullary nailing for an IT fracture can benefit from a single dose of 15 mg/kg TXA before the onset of surgery. A similar tendency was identified in patients undergoing hemiarthroplasty for a subcapital fracture but not to a statistically significant level. Cite this article: Bone Joint J 2021;103-B(3):442–448

We have previously reported the short-term radiological results of a randomised controlled trial comparing kinematically aligned total knee replacement (TKR) and mechanically aligned TKR, along with early pain and function scores. In this study we report the two-year clinical results from this trial. A total of 88 patients (88 knees) were randomly allocated to undergo either kinematically aligned TKR using patient-specific guides, or mechanically aligned TKR using conventional instruments. They were analysed on an intention-to-treat basis. The patients and the clinical evaluator were blinded to the method of alignment. At a minimum of two years, all outcomes were better for the kinematically aligned group, as determined by the mean Oxford knee score (40 (15 to 48) versus 33 (13 to 48); p = 0.005), the mean Western Ontario McMaster Universities Arthritis index (WOMAC) (15 (0 to 63) versus 26 (0 to 73); p = 0.005), mean combined Knee Society score (160 (93 to 200) versus 137 (64 to 200); p= 0.005) and mean flexion of 121° (100 to 150) versus 113° (80 to 130) (p = 0.002). The odds ratio of having a pain-free knee at two years with the kinematically aligned technique (Oxford and WOMAC pain scores) was 3.2 (p = 0.020) and 4.9 (p = 0.001), respectively, compared with the mechanically aligned technique. Patients in the kinematically aligned group walked a mean of 50 feet further in hospital prior to discharge compared with the mechanically aligned group (p = 0.044). In this study, the use of a kinematic alignment technique performed with patient-specific guides provided better pain relief and restored better function and range of movement than the mechanical alignment technique performed with conventional instruments. Cite this article: Bone Joint J 2014;96-B:907–13

Aims. Vitamin E-infused highly crosslinked polyethylene (VEPE) has been introduced into total hip arthroplasty (THA) with the aim of further improving the wear characteristics of moderately and highly crosslinked polyethylenes (ModXLPE and HXLPE). There are few studies analyzing the outcomes of vitamin E-infused components in cemented arthroplasty, though early acetabular component migration has been reported. The aim of this study was to measure five-year polyethylene wear and acetabular component stability of a cemented VEPE acetabular component compared with a ModXLPE cemented acetabular component. Methods. In a prospective randomized controlled trial (RCT), we assessed polyethylene wear and acetabular component stability (primary outcome) with radiostereometric analysis (RSA) in 68 patients with reverse hybrid THA at five years follow-up. Patients were randomized to either a VEPE or a ModXLPE cemented acetabular component. Results. Mean polyethylene wear in the proximal direction was 0.17 mm (SD 0.15) for the VEPE group and 0.20 mm (SD 0.09) for the ModXLPE group (p = 0.005) at five years. Annual proximal wear rates were 0.03 mm/year (VEPE) and 0.04 mm/year (ModXLPE). Total 3D wear was 0.21 mm (SD 0.26) and 0.23 mm (SD 0.10) for the VEPE and ModXLPE groups, respectively (p = 0.009). Total 3D cup translation was 0.72 mm (SD 0.70) (VEPE) and 0.50 mm (SD 0.44) (ModXLPE) (p = 0.409). Conclusion. At five years, there was less polyethylene wear in the VEPE group than in the ModXLPE group. Both VEPE and ModXLPE cemented components showed low annual wear rates. Component stability was similar in the two groups and remained constant up to five years. Whether these results will equate to a lower long-term revision rate is still unknown. Cite this article: Bone Joint J 2020;102-B(12):1646–1653

Aims. To compare the in vivo long-term fixation achieved by two acetabular components with different porous ingrowth surfaces using radiostereometric analysis (RSA). Methods. This was a minimum ten-year follow-up of a prospective randomized trial of 62 hips with two different porous ingrowth acetabular components. RSA exams had previously been acquired through two years of follow-up. Patients returned for RSA examination at a minimum of ten years. In addition, radiological appearance of these acetabular components was analyzed, and patient-reported outcome measures (PROMs) obtained. Results. In all, 15 hips were available at ten years. There was no statistically significant difference in PROMS between the two groups; PROMs were improved at ten years compared to preoperative scores. Conventional radiological assessment revealed well-fixed components. There was minimal movement for both porous surfaces in translation (X, Y, Z, 3D translation in mm (median and interquartile range (IQR)), StikTite (Smith and Nephew, Memphis, Tennessee, USA): 0.03 (1.08), 0.12 (0.7), 0.003 (2.3), 0.37 (0.30), and Roughcoat (Smith and Nephew): -0.6 (0.59),–0.1 (0.49), 0.1 (1.12), 0.48 (0.38)), and rotation (X, Y, Z rotation in degrees (median and IQR), (Stiktite: -0.4 (3), 0.28 (2), -0.2 (1), and Roughcoat: - 0.4 (1),–0.1 (1), 0.2 (2)). There was no statistically significant difference between the two cohorts (p-value for X, Y, Z, 3D translation - 0.54, 0.46, 0.87, 0.55 and for X, Y, Z rotation - 0.41, 0.23, 0.23 respectively) at ten years. There was significant correlation between two years and ten years 3D translation for all components (r = 0.81(p =< 0.001)). Conclusion. Both porous ingrowth surfaces demonstrated excellent fixation on plain radiographs and with RSA at ten years. Short-term RSA data are good predictors for long-term migration data

Aims

The objective of this study was to compare the two-year migration and clinical outcomes of a new cementless hydroxyapatite (HA)-coated titanium acetabular shell with its previous version, which shared the same geometrical design but a different manufacturing process for applying the titanium surface.

Aims. In a randomized controlled trial with two-year follow-up, patients treated with suture button (SB) for acute syndesmotic injury had better outcomes than patients treated with syndesmotic screw (SS). The aim of this study was to compare clinical and radiological outcomes for these treatment groups after five years. Methods. A total of 97 patients with acute syndesmotic injury were randomized to SS or SB. The five-year follow-up rate was 81 patients (84%). The primary outcome was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Scale. Secondary outcome measures included Olerud-Molander Ankle (OMA) score, visual analogue scale (VAS), EuroQol five-dimension questionnaire (EQ-5D), range of movement, complications, reoperations, and radiological results. CT scans of both ankles were obtained after surgery, and after one, two, and five years. Results. The SB group had higher median AOFAS score (100 (interquartile range (IQR) 92 to 100) vs 90 (IQR 85 to 100); p = 0.006) and higher median OMA score (100 (IQR 95 to 100) vs 95 (IQR 75 to 100); p = 0.006). The SS group had a higher incidence of ankle osteoarthritis (OA) (24 (65%) vs 14 (35%), odds ratio (OR) 3.4 (95% confidence interval (CI) 1.3 to 8.8); p = 0.009). On axial CT we measured a significantly smaller mean difference in the anterior tibiofibular distance between injured and non-injured ankles in the SB group (–0.1 mm vs 1.2 mm; p = 0.016). Conclusion. Five years after syndesmotic injury treated with either SB or SS, we found better AOFAS and OMA scores, and lower incidence of ankle OA, in the SB group. These long-term results favour the use of SB when treating an acute syndesmotic injury. Cite this article: Bone Joint J 2020;102-B(2):212–219

Aims. It is unknown whether kinematic alignment (KA) objectively improves knee balance in total knee arthroplasty (TKA), despite this being the biomechanical rationale for its use. This study aimed to determine whether restoring the constitutional alignment using a restrictive KA protocol resulted in better quantitative knee balance than mechanical alignment (MA). Methods. We conducted a randomized superiority trial comparing patients undergoing TKA assigned to KA within a restrictive safe zone or MA. Optimal knee balance was defined as an intercompartmental pressure difference (ICPD) of 15 psi or less using a pressure sensor. The primary endpoint was the mean intraoperative ICPD at 10° of flexion prior to knee balancing. Secondary outcomes included balance at 45° and 90°, requirements for balancing procedures, and presence of tibiofemoral lift-off. Results. A total of 63 patients (70 knees) were randomized to KA and 62 patients (68 knees) to MA. Mean ICPD at 10° flexion in the KA group was 11.7 psi (SD 13.1) compared with 32.0 psi in the MA group (SD 28.9), with a mean difference in ICPD between KA and MA of 20.3 psi (p < 0.001). Mean ICPD in the KA group was significantly lower than in the MA group at 45° and 90°, respectively (25.2 psi MA vs 14.8 psi KA, p = 0.004; 19.1 psi MA vs 11.7 psi KA, p < 0.002, respectively). Overall, participants in the KA group were more likely to achieve optimal knee balance (80% vs 35%; p < 0.001). Bone recuts to achieve knee balance were more likely to be required in the MA group (49% vs 9%; p < 0.001). More participants in the MA group had tibiofemoral lift-off (43% vs 13%; p < 0.001). Conclusion. This study provides persuasive evidence that restoring the constitutional alignment with KA in TKA results in a statistically significant improvement in quantitative knee balance, and further supports this technique as a viable alternative to MA. Cite this article: Bone Joint J. 2020;102-B(1):117–124

Aims. The primary aim of this study was to compare the postoperative systemic inflammatory response in conventional jig-based total knee arthroplasty (conventional TKA) versus robotic-arm assisted total knee arthroplasty (robotic TKA). Secondary aims were to compare the macroscopic soft tissue injury, femoral and tibial bone trauma, localized thermal response, and the accuracy of component positioning between the two treatment groups. Methods. This prospective randomized controlled trial included 30 patients with osteoarthritis of the knee undergoing conventional TKA versus robotic TKA. Predefined serum markers of inflammation and localized knee temperature were collected preoperatively and postoperatively at six hours, day 1, day 2, day 7, and day 28 following TKA. Blinded observers used the Macroscopic Soft Tissue Injury (MASTI) classification system to grade intraoperative periarticular soft tissue injury and bone trauma. Plain radiographs were used to assess the accuracy of achieving the planned postioning of the components in both groups. Results. Patients undergoing conventional TKA and robotic TKA had comparable changes in the postoperative systemic inflammatory and localized thermal response at six hours, day 1, day 2, and day 28 after surgery. Robotic TKA had significantly reduced levels of interleukin-6 (p < 0.001), tumour necrosis factor-α (p = 0.021), ESR (p = 0.001), CRP (p = 0.004), lactate dehydrogenase (p = 0.007), and creatine kinase (p = 0.004) at day 7 after surgery compared with conventional TKA. Robotic TKA was associated with significantly improved preservation of the periarticular soft tissue envelope (p < 0.001), and reduced femoral (p = 0.012) and tibial (p = 0.023) bone trauma compared with conventional TKA. Robotic TKA significantly improved the accuracy of achieving the planned limb alignment (p < 0.001), femoral component positioning (p < 0.001), and tibial component positioning (p < 0.001) compared with conventional TKA. Conclusion. Robotic TKA was associated with a transient reduction in the early (day 7) postoperative inflammatory response but there was no difference in the immediate (< 48 hours) or late (day 28) postoperative systemic inflammatory response compared with conventional TKA. Robotic TKA was associated with decreased iatrogenic periarticular soft tissue injury, reduced femoral and tibial bone trauma, and improved accuracy of component positioning compared with conventional TKA. Cite this article: Bone Joint J 2021;103-B(1):113–122

Aims. The purpose of the present study was to compare patient-specific instrumentation (PSI) and conventional surgical instrumentation (CSI) for total knee arthroplasty (TKA) in terms of early implant migration, alignment, surgical resources, patient outcomes, and costs. . Patients and Methods. The study was a prospective, randomized controlled trial of 50 patients undergoing TKA. There were 25 patients in each of the PSI and CSI groups. There were 12 male patients in the PSI group and seven male patients in the CSI group. The patients had a mean age of 69.0 years (. sd. 8.4) in the PSI group and 69.4 years (. sd. 8.4) in the CSI group. All patients received the same TKA implant. Intraoperative surgical resources and any surgical waste generated were recorded. Patients underwent radiostereometric analysis (RSA) studies to measure femoral and tibial component migration over two years. Outcome measures were recorded pre- and postoperatively. Overall costs were calculated for each group. Results. There were no differences (p > 0.05) in any measurement of migration at two years for either the tibial or femoral components. Movement between one and two years was < 0.2 mm, indicating stable fixation. There were no differences in coronal or sagittal alignment between the two groups. The PSI group took a mean 6.1 minutes longer (p = 0.04) and used a mean 3.4 less trays (p < 0.0001). Total waste generated was similar (10 kg) between the two groups. The PSI group cost a mean CAD$1787 more per case (p < 0.01). Conclusion. RSA criteria suggest that both groups will have revision rates of approximately 3% at five years. The advantages of PSI were minimal or absent for surgical resources used and waste eliminated, and for meeting target alignment, yet had significantly greater costs. Therefore, we conclude that PSI may not offer any advantage over CSI for routine primary TKA cases. Cite this article: Bone Joint J 2019;101-B:565–572

Aims. Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Methods. Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre. Results. At day one, three, and seven, data on pain, function, QoL, immobilization, and analgesia will be collected. Three and six weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the Wong-Baker FACES pain scale at three days post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardian. Cite this article: Bone Joint Open 2020;1-6:214–221

We performed two independent, randomised, controlled trials in order to assess the potential benefits of immediate weight-bearing mobilisation after rupture of the tendo Achillis. The first trial, on operatively-treated patients showed an improved functional outcome for patients mobilised fully weight-bearing after surgical repair. Two cases of re-rupture in the treatment group suggested that careful patient selection is required as patients need to follow a structured rehabilitation regimen. The second trial, on conservatively-treated patients, provided no evidence of a functional benefit from immediate weight-bearing mobilisation. However, the practical advantages of immediate weight-bearing did not predispose the patients to a higher complication rate. In particular, there was no evidence of tendon lengthening or a higher re-rupture rate. We would advocate immediate weight-bearing mobilisation for the rehabilitation of all patients with rupture of the tendo Achillis

The ideal form of fixation for displaced, extra-articular fractures of the distal tibia remains controversial. In the UK, open reduction and internal fixation with locking-plates and intramedullary nailing are the two most common forms of treatment. Both techniques provide reliable fixation but both are associated with specific complications. There is little information regarding the functional recovery following either procedure. We performed a randomised pilot trial to determine the functional outcome of 24 adult patients treated with either a locking-plate (n = 12) or an intramedullary nailing (n = 12). At six months, there was an adjusted difference of 13 points in the Disability Rating Index in favour of the intramedullary nail. However, this was not statistically significant in this pilot trial (p = 0.498). A total of seven patients required further surgery in the locking-plate group and one in the intramedullary nail group. This study suggests that there may be clinically relevant, functional differences in patients treated with nail versus locking-plate fixation for fractures of the distal tibia and differences in related complications. Further trials are required to confirm the findings of this pilot investigation

Aims. Femoroacetabular Junction Impingement (FAI) describes abnormalities in the shape of the femoral head–neck junction, or abnormalities in the orientation of the acetabulum. In the short term, FAI can give rise to pain and disability, and in the long-term it significantly increases the risk of developing osteoarthritis. The Femoroacetabular Impingement Trial (FAIT) aims to determine whether operative or non-operative intervention is more effective at improving symptoms and preventing the development and progression of osteoarthritis. . Methods. FAIT is a multicentre superiority parallel two-arm randomised controlled trial comparing physiotherapy and activity modification with arthroscopic surgery for the treatment of symptomatic FAI. Patients aged 18 to 60 with clinical and radiological evidence of FAI are eligible. Principal exclusion criteria include previous surgery to the index hip, established osteoarthritis (Kellgren–Lawrence ≥ 2), hip dysplasia (centre-edge angle < 20°), and completion of a physiotherapy programme targeting FAI within the previous 12 months. Recruitment will take place over 24 months and 120 patients will be randomised in a 1:1 ratio and followed up for three years. The two primary outcome measures are change in hip outcome score eight months post-randomisation (approximately six-months post-intervention initiation) and change in radiographic minimum joint space width 38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Bone Joint Res 2014;3:321–7

Aims

The aim of this study was to compare the functional and radiological outcomes and the complication rate after nail and plate fixation of unstable fractures of the ankle in elderly patients.

Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention