Treatment of tibial bone defects: pilot analysis of direct medical costs between distraction osteogenesis with an Ilizarov frame and the Masquelet technique

The complexity of managing large bone defects is well-described in the literature, as well as the various methods of treatment [2, 3], and their results. [30,31,32] However, evidence on the health economic aspect of their effective management is extremely scarce [33]. Theoretically, a complete health economic analysis includes direct, indirect, and intangible costs [4], whereas a cost effectiveness study should address both the societal and the health-care payer perspectives evaluating all relevant costs and benefits to the patient over their lifetime [34, 35].

Recently, Norris et al. [33] published a database analysis utilizing two different US-based sources including 904 patients with either the diagnosis of fracture/nonunion/osteomyelitis, treated with bone graft, cement spacer, or a frame fixator. Payer costs were analysed from the index admission to 12 months postoperatively. They concluded that patients with large defects require extended therapies, multiple hospital visits and admissions, representing a significant financial challenge.

Limb reconstruction procedures (ILF and MIF) are considered discrete episodes of care, associated with high up-front costs [33]. With this pilot cost analysis, we aimed to explore the differences of direct medical costs of the two main methods of managing acute or nonunion tibial defects in the best-case scenario of a successful union.

Within the limitations of our study, we recognise that we analysed a small number of patients (type II error). The size of our sample was not based on statistical power calculations, as the scope of this pilot study was to show the feasibility of collecting the data for conducting robust and detailed cost analysis and inform future evaluations of costs and effectiveness. The small number of patients in each subgroup prevented us from adjusting for clinical differences in terms of gender, Charlson’s score, etc. Since we studied a representative sample of patients with successful defect union (best-case scenario), our means and standard deviations may be artificially small, whilst we have compared values following their log transformation to address skewness. According to the power calculation based on the data herein, 35 patients from each group at a 1:1 ratio will be required to detect a 25% difference, with an alpha value of 0.05 and probability (power) of 0.9.

This study does refer to patients with complete data and a successful discharge following healing of their tibial defect. All possible direct medical costs during the initial treatment period, outpatient care, readmissions, and reoperations were measured. Exceptions were costs of outpatient rehabilitation, medications prescribed from primary care or purchased privately, and those of outpatient-parenteral-antibiotic-therapy services (OPAT), as well as productivity losses relevant to time off work. Noteworthy, the absence of health-related quality-of-life measures in this series, as well as the lack of adequate data in the literature, does not allow the comparison in QALY terms, but only into numerical figures of these direct medical costs.

The described clinical results in our series were found to be in accordance with other similar series for both the ILF [6, 36,37,38,39] and MIF [26, 30, 40, 41] methods. The demographics and bone defect size, the mean healing index of 2.1, and the incidence of complications per Paley classification [42] of the 5 ILFn patients in this study are consistent with those in the series of Krappinger et al. [38] Similarly, the baseline characteristics and overall outcome (mean healing index of 2.2 months/cm) reported by Mekhail et al.[39] were comparable to our subgroup of ILFa patients.

Main contributors on the cost differences noted (Tables 3, 4) were those related to the OR, and the more intense follow-up ILF patients require till defect union and consolidation of the regenerate bone. This is consistent with existing meta-analysis studies [30,31,32]. Selection bias between the groups is possible, as patients were not randomised preoperatively to receive either of the two methods.

The comparison between acute and nonunion/infected defects revealed lower number of admissions (p = 0.036), shorter follow-up (p = 0.04), and time-to-union for the acute defects (p = 0.048). No statistically significant differences were observed for the cost of infected cases (p = 0.537). This is perhaps attributable to the relatively low costs of the antibiotic therapies and the fact that it was not possible to capture costs incurred by primary care providers (including those of the OPAT service).

There is clear need for a pivotal health economic evaluation in this area, utilising the findings and some of the methodological aspects of the current study. The absolute need of using a health-related quality-of-life score as utility measures in future clinical series is also apparent to facilitate the translation of patient reported outcomes into effectiveness measures that are adequate to inform the optimal allocation of the scarce healthcare resources [34, 35].

Currently, in the NHS, limb reconstruction belongs to the specialist high-cost-tariff-excluded devices (HCTED) [43], attracting certain uplifts to their reimbursement. The generation of robust health economic evidence is expected to facilitate the update of such reimbursement arrangements, and their adoption into those managed with different techniques, as the Masquelet method.

This study does not report on the exact revenue of our unit, as this is influenced from the reimbursement arrangements of our hospital, and the reduced prices following the local implant tender. To provide more generalizable evidence, which could be relevant to different clinical groups, we based all our study on generic price lists and cost values, which do not take into account local negotiated prices.

The clinical need to have both methods available, together with others, is apparent from their widespread use globally. Each technique provides different features and advantages which make them preferable to certain scenarios. Bone transport (ILF) has many proven advantages in complex defects with associated deformities, allowing simultaneous tackling of all associated problems (bone defect reconstruction, realignment, infection control, mechanical stability, and immediate mobilisation) [6, 37, 44]. The more recently introduced Masquelet technique offers similar advantages and successful defect management independent of defect size. In addition, it requires less intense follow-up and probably is better suited for less compliant patients. [5, 40, 41]

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