The impact of different health dimensions on overall quality of life related to kyphoplasty and non-surgical management.

UNLABELLED: This study uses data from a previously published randomised trial where balloon kyphoplasty was compared to non-surgical management. Of the improved overall quality of life, 60 % was caused by decreased pain. However, ignoring other dimensions of quality of life would underestimate the procedure's effect. INTRODUCTION: Acute back pain has been viewed as the most important factor lowering quality of life (QoL) for patients suffering vertebral fractures. The objective of this study was to quantify the impact of different health dimensions on overall QoL using patient-reported outcome measurements (PROMs) collected in Fracture Reduction Evaluation (FREE) trial. METHODS: The analysis was based on patients included in the 2-year-long randomised controlled FREE trial studying the efficacy and safety of balloon kyphoplasty procedure (BKP) compared to non-surgical management (NSM). The PROMs included were EQ-5D, Short Form (SF)-36, visual analogue scale (VAS) pain and the Roland-Morris Disability Questionnaire (RMDQ). The health dimensional contribution to the overall QoL improvements was analysed by isolating the impact of each dimension on QoL in the SF-36 and EQ-5D, respectively. A correlation analysis of the QoL improvement was performed to investigate the relationships between the four instruments. RESULTS: Changes in pain explained 60 % of the quality-adjusted life years (QALY) gained in BKP vs. NSM followed by self-care (17 %), mobility (16 %) and usual activities (10 %) (EQ-5D). Health dimensions capturing the mental state had little impact on the QALY gained. The SF-36 dimensional analysis showed similar results. The correlation analysis showed that the correlation between VAS pain, RMDQ and QALY improvement was fairly weak. CONCLUSIONS: Changes in the pain dimension of health are the most important drivers for changes of overall QoL in patients treated with BKP or NSM. However, ignoring the impact of other dimensions would lead to an underestimation of the actual improvement in overall QoL.

Mechanical properties of calcium sulphate/hydroxyapatite cement.

Setting times, volume after setting, injectability and hardness (at 37 degrees C in contact with Ringer's solution) were determined for cements made of mixtures of calcium sulphate hemihydrate (CS) and hydroxyapatite (HA) with a range of compositions. The purpose of these experiments was to determine the behaviour of a mixture that could be used as an injectable cement for orthopaedic applications, including spinal fusion. A suitable mixture consisted of 60% CS and 40% HA by mass; a slurry was made by mixing solid (36 g) with water (15 cm(3)). The slurry had initial and final setting times of 5.7+/-1.3 min and 19.6+/-0.7 min (mean +/- standard deviation), respectively. The hardness of the cement did not systematically increase or decrease in the 72 h following the final setting time. The volume of the cement was 99.8+/-0.4% of the volume of the initial slurry, i.e. there was negligible shrinkage on setting. It was able to withstand a pressure of 7.3+/-1.2 MPa, applied by a hemispherical indenter before the onset of permanent damage, indicating adequate strength for spinal fusion.

Does early imaging influence management and improve outcome in patients with low back pain? A pragmatic randomised controlled trial.

OBJECTIVES: To establish whether the early use of sophisticated imaging techniques influences the clinical management and outcome of patients with low back pain (LBP) and whether it is cost-effective. DESIGN: A pragmatic multicentre randomised controlled trial using a standard two parallel group approach incorporating an economic evaluation. For a subgroup of trial participants, a controlled 'before and after' approach was used to assess the impact of 'early imaging' on clinicians' diagnostic and therapeutic confidence. SETTING AND PARTICIPANTS: A total of 782 participants who had been referred by their general practitioner to a consultant orthopaedic specialist or neurosurgeon because of symptomatic lumbar spine disorders. The study included 14 hospitals in Scotland and one in England over a 24-month period. RESULTS: Participants in both groups reported an improvement in health status at 8 and 24 months with the 'early imaging' group having statistically significantly better outcome. Other than the proportion of participants receiving imaging (90% versus 30%), there were few differences between the groups in the management received throughout the 24-month follow-up. The total number of outpatient consultations in the two groups was similar although more people in the 'early imaging' group had return outpatient appointments during the 8-month follow-up. Clinicians' diagnostic confidence, between trial entry and follow-up, increased significantly for both groups with a greater increase in the 'early imaging' group. The cost of imaging was the main determinant of the difference in total costs between the groups and it was estimated that 'early imaging' could provide an additional 0.07 quality-adjusted life-years (QALYs), at an additional average cost of 61 British pounds over the 24-month follow-up. Using non-imputed costs and QALYs but adjusted for baseline differences in EQ-5D score, the mean incremental cost per QALY of 'early imaging' was 870 British pounds. The results were sensitive to the costs of imaging and the confidence intervals surrounding estimates of average costs and QALYs. CONCLUSIONS: The early use of sophisticated imaging does not appear to affect management overall but does result in a slight improvement in clinical outcome at an estimated cost of 870 British pounds per QALY. Imaging was associated with an increase in clinicians' diagnostic confidence, particularly for non-specialists. Further research is required to determine if more rapid referral to sophisticated imaging and secondary care is important in the acute episode and whether the use of imaging would be more beneficial for particular categories of LBP.

Developing a valid and reliable measure of health outcome for patients with low back pain.

OBJECTIVE: The authors developed and validated a measure of health outcome for patients with low back pain. RESULTS: A questionnaire was developed incorporating the type of questions asked when taking a clinical history. After testing on a sample of 568 patients, three questions were discarded from the questionnaire. The final questionnaire was found to be reliable and valid in the sense that patients' scores correlated highly with their scores on a general health profile and with GP perceptions of severity. Health status in patients with low back pain was significantly impaired when compared with the general population. CONCLUSION: A clinically based questionnaire, together with a general measure of health, can provide a valid and reliable package for the routine assessment of perceived health in patients with low back pain.

The cast-brace treatment of femoral shaft fractures.

Ninety-eight fractures of the shaft of the femur were seen in one unit over the two years 1974 and 1975, and the results have been assessed in sixty-nine. Of these, thirty-eight were treated by skeletal traction in a Thomas's splint followed by skin traction, and thirty-one by skeletal traction followed by a cast-brace. The technique of application is described in some detail. The average time for application of the cast-brace was six weeks after the injury, the time in hospital eight weeks and the time till removal fifteen weeks. The patients selected for a cast-brace were in hospital for just over half the time of the others and their fractures on average united more quickly, though with some trouble from angulation of fractures of the uppermost third of the shaft. It is concluded that when used with all the judgment and skill it demands, the cast-brace method is a great advance in conservative treatment.

The use of cast-bracing as treatment for fractures of the tibial plateau.

A series of 29 patients with fractures of the tibial plateau were treated by means of a cast-brace. There were seven wedge fractures of the lateral tibial condyle, two dicondylar fractures and 20 compression fractures involving the lateral tibial plateau. The seven patients with wedge fractures were treated by skin or skeletal traction, followed as soon as possible by flexion exercises for the knee. Cast-braces were applied to all fractures as soon as possible after injury, and the patients allowed to bear weight freely. Early restoration of function of the injured limb was thereby achieved. The results of our study over a period of two and a half years indicate that cast-bracing is a very satisfactory method of treating fractures of the tibial plateau. All the fractures united, the movements and control of the knee were excellent, and valgus or varus deformity was unchanged before application and after removal of the brace.

A biomechanical study of cast-brace treatment of femoral shaft fractures.

The off-loading characteristics of the cast-braces of 30 patients with fractures of the shaft of the femur have been investigated, during axial loading, using strain-gauge transducers. These were applied at the level of the fracture, where the cast was circumferentially split, and to the hinges of the brace at the knee. They measured the load transferred between the two portions of the thigh cast, and between the thigh cast as a whole and the below-knee cast; by subtraction from the total load on the limb, the skeletal force at the fracture level and at the knee could be calculated. In all patients there was an increase in the fracture load as union progressed which was thought to be due to physiological feedback mechanism from the fracture site. The load carried by the two portions of the thigh cast and by the thigh cast as a whole was proportionately high at first and stabilised at an average of 35 per cent of body weight.

Aberdeen Colles' fracture brace as a treatment for Colles' fracture. A multicentre, prospective, randomised, controlled trial.

We carried out a randomised, prospective, multicentre clinical trial of the treatment of Colles' fractures. A total of 339 patients was placed into two groups, those with minimally displaced fractures not requiring manipulation (151 patients) and those with displaced fractures which needed manipulation (188 patients). Treatment was by either a conventional Colles' plaster cast (a control group) or with a prefabricated functional brace (the Aberdeen Colles' fracture brace). Similar results were obtained in both groups with regard to the reduction and to pain scores but the brace provided better grip strength in the early stages of treatment. This was statistically significant after five weeks for both manipulated and non-manipulated fractures. At the tenth day the results were statistically significant only in manipulated fractures. There was no significant difference in the functional outcome between the two treatment groups. However, younger patients and those with less initial displacement had better functional results.

Modern splinting bandages.

We have assessed the current range of synthetic splinting bandages, using physical and mechanical tests and the subjective opinions of patients, volunteers and orthopaedic staff. Modern bandages have some better properties than standard plaster bandage but do not conform as well, are more expensive, and potentially more hazardous.

Traumatic dislocation of the lateral sesamoid of the great toe: nonoperative management.

A case of traumatic dislocation of the lateral sesamoid of flexor hallucis brevis tendon associated with metatarsal neck fractures due to a crush injury is reported. This patient was treated nonoperatively by elevation, application of plaster, and then free mobilisation. The patient has now fully recovered and remains completely asymptomatic despite residual sesamoid dislocation 1 year after the injury. The nonoperative management of this injury has not, to our knowledge, been reported previously.

Slippage of a spinous process hook during flexion in a flexible fixation system for the lumbar spine.

This study was undertaken to measure the amount of slippage of a spinous process hook (that forms part of a flexible fixation system) during flexion. Human cadaveric lumbar spines (10) were fitted with the device. A rig was designed to apply flexural displacements to a spine using a materials testing machine. Spherical markers were attached to the spine and hook. As a spine was flexed a digital video camera was used to record the positions of the markers. The movements of the markers were measured using interactive computer software to assess any slippage of the spinous process hook. During flexion the overall mean hook slippage was measured to be 0.10mm (standard deviation 0.04mm). The mean hook slippage, for each of the 10 specimens, was in the range of 0.05-0.14mm. The results imply that slippage of a spinous process hook during flexion is small.

Microcomputer-based system for clinical gait studies.

A microcomputer-based gait recording system is described which can be used to analyse gait routinely in the clinical environment. Foot-ground reaction forces are acquired and processed and the resultant force vector is superimposed on the television image of the subject in real time. A TV-computer interface quantifies the position of reflective markers attached to the joint centres of the lower limb, and moment values, stick-figure diagrams, and joint angle changes can also be displayed shortly after data collection. The system has routine clinical applications in orthotics and prosthetics and is also a valuable tool in teaching the biomechanics of human movement.

Determination of stresses in below-knee walking casts.

Glass fibre bandages are now commonly used for definitive below-knee walking casts, in preference to plaster of Paris, since they are better able to withstand the stresses imposed upon them. This paper describes a technique for recording the cast strains in glass fibre bandages and shows typical stress levels in patient and volunteer casts. A typical map of the stress variations in walking casts during gait in a volunteer has been produced. The study shows that the high stresses recorded along the medial and lateral borders of the foot by the strain gauge technique are confirmed by clinical experience, since this is where failure is most commonly seen in below-knee walking casts. It is concluded that the current generation of polyurethane impregnated glass fibre splinting bandages are too brittle in many cases for below-knee walking casts and that a more flexible fabric would reduce the incidence of cast breakdown.

Design of spinous process hooks for flexible fixation of the lumbar spine.

A prototype flexible fixation system for the lumbar spine was subjected to tensile testing to failure and cyclic tensile testing in order to determine any regions of weakness. The system consisted of a spinous process hook and two laminar hooks made of stainless steel (316L). Each laminar hook was attached to the spinous process hook by a loop of polyester braid secured by a crimped metal sleeve. In five tensile tests, the system failed by irreversible deformation of the spinous process hook at 2.5 +/- 0.3 kN (mean +/- standard deviation). In three cyclic tests, in which the applied tension varied sinusoidally between 0.04 and 0.4 kN at a frequency of 5 Hz, failure occurred after less than 400,000 loading cycles. This occurred as a result of fatigue crack initiation and propagation in the spinous process hook. A finite element model showed a stress concentration in the region where the crack occurred, which raised the applied stress above the tensile fatigue strength of this stainless steel. The spinous process hook was redesigned for manufacture in a titanium alloy (Ti-6AI-4V ELI) to minimize artefacts in magnetic resonance imaging. Further finite element models showed no unacceptable stress concentrations.

Development of surgical instruments for implanting a flexible fixation device for the lumbar spine.

A new flexible fixation device for the lumbar spine has been developed. This paper describes the development and evaluation of two surgical instruments required for implanting this device. Prototypes were designed, manufactured and then evaluated for use in surgery. Further evaluation was performed, if necessary, and the design finalized, in accordance with BS EN 12011. This process involved close collaboration between engineers and surgeons.

Social and emotional learning: a framework for promoting mental health and reducing risk behavior in children and youth.

Many programs have been developed to help schools enhance students' health and reduce the prevalence of drug use, violence, and high-risk sexual behaviors. How should educators choose among these? This article describes selection criteria based on theory, research, and best educational practice that identify key social and emotional learning (SEL) competencies and program features. The SEL competencies for students include 17 skills and attitudes organized into four groups: awareness of self and others; positive attitudes and values; responsible decision making; and social interaction skills. The 11 program features critical to the success of school-based SEL programs emphasize curriculum design, coordination with larger systems, educator preparation and support, and program evaluation. Developed by the Collaborative to Advance Social and Emotional Learning (CASEL), the SEL framework can be used to guide selection of research-based prevention programs that address health, substance abuse, violence prevention, sexuality, character, and social skills.

New splinting materials.

Plaster of Paris (P.o.P.) bandage has been the pre-eminent external splinting material for over 150 years and from time to time synthetic alternatives have been tried. So far none has seriously challenged the dominance of P.o.P. as a primary or secondary material in the management of fractures. The recent introduction of Polyurethane coated fibreglass bandage appears to offer a more serious challenge than previous contenders. This technical note reviews bandage type splinting materials and explains some of the properties of the PU materials.

Biomechanical assessment of gait in below-knee walking casts.

The introduction of modern synthetic casting bandages for splinting of fractures and soft tissue injuries has allowed the development of new casting techniques. Casts can be constructed with a greater degree of function so that controlled motion and stabilisation can be provided within the same cast. This study has shown that a very efficient gait can be achieved with modern synthetic bandages, if they are correctly applied. The authors have compared the gait of volunteer subjects fitted respectively with below-knee walking casts constructed from a rigid glass fibre bandage and a flexible glass fibre bandage which is reinforced. These casts were wrapped so that minimal amounts of bandage were used whilst appropriate strength and stiffness was provided. The temporal and spatial factors of cast gait were not statistically different from normal gait. The cast gait was found to be slightly more asymmetrical (dominant versus non-dominant leg) when a cast was worn and there was also a greater Physiological Cost Index (PCI). The flexible bandage has some advantages compared with the rigid bandage as normal footwear can be worn, the casts are more comfortable and they could be removed with shears, obviating the need for a power saw.

Mechanical assessment of polyurethane impregnated fibreglass bandages for splinting.

The introduction of polyurethane (PU) resin impregnated fibreglass bandages is likely to have a significant effect on modern orthopaedic practice. The manufacturers of these products claim many improved properties compared to plaster of Paris bandages, such as , high strength to weight ratio, rapid setting time and high radiolucency. This paper reports on a series of mechanical tests designed to assess the strength, flexibility, working time and wear properties of the current range of fibreglass bandages and to compare them with plaster of Paris bandages. The results have clearly demonstrated that the fibreglass bandages are mechanically superior and offer numerous advantages over plaster of Paris for use as the definitive casting material for both weight-bearing and non-weight-bearing casts.

Dust emission during cutting of polyurethane-impregnated bandages.

The airborne dust generated when cutting splinting bandages represents a potential respiratory hazard, particularly to those who regularly remove casts with a power saw. Plaster of Paris (POP) dust is already classified by the Health and Safety Executive as a nuisance dust. This paper reports on a study to determine the nature, size and concentration of dust produced when cutting polyurethane (PU) impregnated bandages using a power saw. It has been shown that, under severe conditions PU bandages produce lower airborne dust concentrations than POP bandage but that all of the bandages tested produced particles small enough to reach the final divisions of the lung. It is therefore recommended that a dust extraction unit be used when cutting all types of bandage.