The comprehensive cohort model in a pilot trial in orthopaedic trauma

Background: The primary aim of this study was to provide an estimate of effect size for the functional outcome of operative versus non-operative treatment for patients with an acute rupture of the Achilles tendon using accelerated rehabilitation for both groups of patients. The secondary aim was to assess the use of a comprehensive cohort research design (i.e. a parallel patient-preference group alongside a randomised group) in improving the accuracy of this estimate within an orthopaedic trauma setting. Methods: Pragmatic randomised controlled trial and comprehensive cohort study within a level 1 trauma centre. Twenty randomised participants (10 operative and 10 non-operative) and 29 preference participants (3 operative and 26 non-operative). The ge range was 22-72 years and 37 of the 52 patients were men. All participants had an acute rupture of their Achilles tendon and no other injuries. All of the patients in the operative group had a simple end-to-end repair of the tendon with no augmentation. Both groups then followed the same eight-week immediate weight-bearing rehabilitation programme using an off-the-shelf orthotic. The disability rating index (DRI; primary outcome), EQ-5D, Achilles Total Rupture Score and complications were assessed ed at two weeks, six weeks, three months, six months and nine months after initial injury. Results: At nine months, there was no significant difference in DRI between patients randomised to operative or non-operative management. There was no difference in DRI between the randomised group and the parallel patient preference group. The use of a comprehensive cohort of patients did not provide useful additional information as to the treatment effect size because the majority of patients chose non-operative management. Conclusions: Recruitment to clinical trials that compare operative and non-operative interventions is notoriously difficult; especially within the trauma setting. Including a parallel patient preference group to create a comprehensive cohort of patients has been suggested as a way of increasing the power of such trials. In our study, the comprehensive cohort model doubled the number of patients involved in the study. However, a strong preference for non-operative treatment meant that the increased number of patients did not significantly increase the ability of the trial to detect a difference between the two interventions

Revisión narrativa de las roturas de tendón de Aquiles en deportes de raqueta

This review aims to report the existing research about Achilles tendon ruptures (ATR) in racket sports. Further, this narrative review will also include the acute management, rehabilitation, treatment and prognosis of an ATR. ATR is a common injury among individuals playing racket sports, however, the literature is limited and not up to date. Previous research claims that up to 70 percent of all ATR is related to sports activities where racket sports dominate. A large number of patients sustaining an ATR return to sport within a year from injury.Esta revisión pretende cubrir la investigación existente sobre las roturas del tendón de Aquiles (RTA) en los deportes de raqueta. Adicionalmente, esta revisión narrativa también incluirá el manejo agudo, la rehabilitación, el tratamiento y el pronóstico de una RTA. La RTA es una lesión común entre individuos que practican deportes de raqueta, sin embargo, la literatura es limitada y no está actualizada. Investigaciones previas afirman que hasta el 70% de todas las RTA están relacionadas con actividades deportivas donde predominan los deportes de raqueta. Un gran número de pacientes que sufren RTA regresan al deporte en el plazo de un año desde la lesión

No difference in strength and clinical outcome between early and late repair after Achilles tendon rupture

PURPOSE: This retrospective study aimed to determine the patient-reported and functional outcome of patients with delayed presentation, who had received no treatment until 14 days following injury of Achilles tendon rupture repaired with minimally invasive surgery and were compared with a group of sex- and age-matched patients presenting acutely. Based on the outcomes following delayed presentation reported in the literature, it was hypothesized that outcomes would be inferior for self-reported outcome, tendon elongation, heel-rise performance, ability to return to play, and complication rates than for acutely managed patients. METHODS: Repair was performed through an incision large enough to permit mobilisation of the tendon ends, core suture repair consisting of a modified Bunnell suture proximally and a Kessler suture distally and circumferential running suture augmentation. RESULTS: Nine patients presented 21.8 (14.9) days (range 14-42 days) after rupture. The rate of delayed presentation was estimated to be 1 in 10. At 12 months following repair, patients with delayed treatment had median (range) ATRS score of 90 (69-99) compared with 94 (75-100) in patients treated acutely presenting 0.66 (1.7) (0-5) days. There were no significant differences between groups: ATRA [mean (SD) delayed: - 6.9° (5.5), acute: - 6° (4.7)], heel-rise height index [delayed: 79% (20), acute: 74% (14)], or heel-rise repetition index [delayed: 77% (20), acute: 71% (20)]. In the delayed presentation group, two patients had wound infection and one iatrogenic sural nerve injury. CONCLUSIONS: Patients presenting more than 2 weeks after Achilles tendon rupture may be successfully treated with minimally invasive repair. LEVEL OF EVIDENCE: III

Age and tightness of repair are predictors of heel-rise height after Achilles tendon rupture

Background: Achilles tendon rupture leads to weakness of ankle plantarflexion. Treatment of Achilles tendon rupture should aim to restore function while minimizing weakness and complications of management. Purpose: To determine the influence of factors (age, sex, body mass index [BMI], weight, time from injury to operative repair, and tightness of repair) in the initial surgical management of patients after an acute Achilles tendon rupture on 12-month functional outcome assessment after percutaneous and minimally invasive repair. Study Design: Cohort study; Level of evidence, 3. Methods: From May 2012 to January 2018, patients sustaining an Achilles tendon rupture receiving operative repair were prospectively evaluated. Tightness of repair was quantified using the intraoperative Achilles tendon resting angle (ATRA). Heel-rise height index (HRHI) was used as the primary 12-month outcome variable. Secondary outcome measures included Achilles tendon total rupture score (ATRS) and Tegner score. Stepwise multiple regression was used to create a model to predict 12-month HRHI. Results: A total of 122 patients met the inclusion criteria for data analysis (mean ± SD age, 44.1 ± 10.8 years; 78% male; mean ± SD BMI, 28.1 ± 4.3 kg/m Conclusion: Age was found to be the strongest predictor of outcome after Achilles tendon rupture. The most important modifiable risk factor was the tightness of repair. It is recommended that repair be performed as tight as possible to optimize heel-rise height 1 year after Achilles tendon rupture and possibly to reduce tendon elongation

Modification and cross-linking parameters in hyaluronic acid hydrogels—Definitions and analytical methods

AbstractDefinitions and methods for the quantification of degree of modification and cross-linking in cross-linked hyaluronic acid (HA) hydrogels are outlined. A novel method is presented in which the HA hydrogel is degraded by the enzyme chondroitinase AC and the digest product analyzed by size exclusion chromatography combined with electrospray ionization mass spectrometry (SEC–ESI-MS). This method allows for the determination of effective cross-linker ratio (CrR) which together with the degree of modification (MoD), determined by, e.g. 1H NMR spectroscopy, enables the calculation of the degree of substitution (DS) and degree of cross-linking (CrD).The method, could be applicable to the major cross-linked HA hydrogels currently on the market, and is exemplified here by application to two HA hydrogels. The definitions and methods presented are important contributions in attempts to find relationships between MoD, DS and CrD to mechanical properties as well as to biocompatibility of HA hydrogels

Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial.

BACKGROUND: There has been a recent steep growth in platelet-rich plasma (PRP) use for musculoskeletal conditions, but findings from high quality clinical trial data are lacking in the literature. Here, we describe the statistical analysis plan (SAP) for the Platelet-rich plasma in Achilles Tendon Healing 2 (PATH-2) trial. METHODS: PATH-2 is a pragmatic, parallel-group, multi-centre, double-blinded, randomised, placebo-controlled, superiority trial. The study aims to evaluate the clinical efficacy of PRP in acute Achilles tendon rupture in terms of muscle-tendon function. Patients are identified in the orthopaedic/trauma outpatient clinic. The primary outcome is muscle-tendon work capacity from the Heel Rise Endurance Test result, expressed as the Limb Symmetry Index (work, in joules), at 24 weeks post randomisation. Multivariate linear regression adjusting for the stratification factors (centre and age) and additional prognostic factors will be used to investigate the adjusted effect of the intervention. The analysis will be by modified intention-to-treat. Sensitivity analysis will assess the internal validity of the trial results by performing a per-protocol analysis. Safety will be summarised by treatment arm for all patients who started treatment. Secondary patient-reported outcome measures will be analysed using linear mixed effects models to allow all data collected at all follow-up points to be considered. Missing data will be summarised and reported by treatment arm. Missing data imputation will be performed, if appropriate. DISCUSSION: The PATH-2 trial will be reported in accordance with the CONSORT statement. This SAP publication will avoid bias arising from prior knowledge of the study results. Any changes or deviations from the current SAP will be described and justified in the final report. TRIAL REGISTRATION: ISRCTN registry: ISRCTN54992179 , assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850

Percutaneous & Mini Invasive Achilles tendon repair

Rupture of the Achilles tendon is a considerable cause of morbidity with reduced function following injury. Recent studies have shown little difference in outcome between the techniques of open and non-operative treatment using an early active rehabilitation programme. Meta-analyses have shown that non-operative management has increased risk of re-rupture whereas surgical intervention has risks of complications related to the wound and iatrogenic nerve injury. Minimally invasive surgery has been adopted as a way of reducing infections rates and wound breakdown however avoiding iatrogenic nerve injury must be considered. We discuss the techniques and outcomes of percutaneous and minimally invasive repairs of the Achilles tendon

Sulfatide Recognition by Colonization Factor Antigen CS6 from Enterotoxigenic Escherichia coli

The first step in the pathogenesis of enterotoxigenic Escherichia coli (ETEC) infections is adhesion of the bacterium to the small intestinal epithelium. Adhesion of ETEC is mediated by a number of antigenically distinct colonization factors, and among these, one of the most commonly detected is the non-fimbrial adhesin coli surface antigen 6 (CS6). The potential carbohydrate recognition by CS6 was investigated by binding of recombinant CS6-expressing E. coli and purified CS6 protein to a large number of variant glycosphingolipids separated on thin-layer chromatograms. Thereby, a highly specific binding of the CS6-expressing E. coli, and the purified CS6 protein, to sulfatide (SO3-3Galβ1Cer) was obtained. The binding of the CS6 protein and CS6-expressing bacteria to sulfatide was inhibited by dextran sulfate, but not by dextran, heparin, galactose 4-sulfate or galactose 6-sulfate. When using recombinantly expressed and purified CssA and CssB subunits of the CS6 complex, sulfatide binding was obtained with the CssB subunit, demonstrating that the glycosphingolipid binding capacity of CS6 resides within this subunit. CS6-binding sulfatide was present in the small intestine of species susceptible to CS6-mediated infection, e.g. humans and rabbits, but lacking in species not affected by CS6 ETEC, e.g. mice. The ability of CS6-expressing ETEC to adhere to sulfatide in target small intestinal epithelium may thus contribute to virulence