This 501-patient, multi-centre, randomised controlled trial sought
to establish the effect of low-intensity, pulsed, ultrasound (LIPUS)
on tibial shaft fractures managed with intramedullary nailing. We
conducted an economic evaluation as part of this trial. Data for patients’ use of post-operative healthcare resources
and time taken to return to work were collected and costed using
publicly available sources. Health-related quality of life, assessed
using the Health Utilities Index Mark-3 (HUI-3), was used to derive
quality-adjusted life years (QALYs). Costs and QALYs were compared
between LIPUS and control (a placebo device) from a payer and societal
perspective using non-parametric bootstrapping. All costs are reported
in 2015 Canadian dollars unless otherwise stated.Aims
Patients and Methods
The reliability of the radiological assessment of the healing of tibial fractures remains undetermined. We examined the inter- and intraobserver agreement of the healing of such fractures among four orthopaedic trauma surgeons who, on two separate occasions eight weeks apart, independently assessed the radiographs of 30 patients with fractures of the tibial shaft which had been treated by intramedullary fixation. The radiographs were selected from a database to represent fractures at various stages of healing. For each radiograph, the surgeon scored the degree of union, quantified the number of cortices bridged by callus or with a visible fracture line, described the extent and quality of the callus, and provided an overall rating of healing. The interobserver chance-corrected agreement using a quadratically weighted kappa (κ) statistic in which values of 0.61 to 0.80 represented substantial agreement were as follows: radiological union scale (κ = 0.60); number of cortices bridged by callus (κ = 0.75); number of cortices with a visible fracture line (κ = 0.70); the extent of the callus (κ = 0.57); and general impression of fracture healing (κ = 0.67). The intraobserver agreement of the overall impression of healing (κ = 0.89) and the number of cortices bridged by callus (κ = 0.82) or with a visible fracture line (κ = 0.83) was almost perfect. There are no validated scales which allow surgeons to grade fracture healing radiologically. Among those examined, the number of cortices bridged by bone appears to be a reliable, and easily measured radiological variable to assess the healing of fractures after intramedullary fixation.
We have systematically reviewed the effect of alternative methods of stabilisation of open tibial fractures on the rates of reoperation, and the secondary outcomes of nonunion, deep and superficial infection, failure of the implant and malunion by the analysis of 799 citations on the subject, identified from computerised databases. Although 68 proved to be potentially eligible, only eight met all criteria for inclusion. Three investigators independently graded the quality of each study and extracted the relevant data. One study (n = 56 patients) suggested that the use of external fixators significantly decreased the requirement for reoperation when compared with fixation with plates. The use of unreamed nails, compared with external fixators (five studies, n = 396 patients), reduced the risk of reoperation, malunion and superficial infection. Comparison of reamed with unreamed nails showed a reduced risk of reoperation (two studies, n = 132) with the reamed technique. An indirect comparison between reamed nails and external fixators also showed a reduced risk of reoperation (two studies) when using nails. We have identified compelling evidence that unreamed nails reduced the incidence of reoperations, superficial infections and malunions, when compared with external fixators. The relative merits of reamed
