Up to now, the optimal treatment of displaced intra-articular calcaneus fractures remains controversial even though the equipment and technologies have been developing rapidly. The ELA can provide good visualization of the fracture site but several studies have reported that the postoperative wound complications rate including wound edge necrosis, dehiscence, haematoma or infection is relatively high. The STA can minimize soft tissue damage and reduce the risk of postoperative complication while allowing comparative fracture reduction. Previous studies comparing the therapeutic efficacy and clinical outcomes of ORIF via ELA or STA have showed no significant differences. 16, 32, 34, 48 From our results, the clinical outcomes including the Bohler’s and Gissane angle, VAS scores, AOFAS scores were in accord with previous studies. Nevertheless, to the best of our knowledge, no studies comparing the direct costs and effectiveness of two techniques in China were conducted. Therefore, we have conducted this cost-utility analysis and provide another perspective for surgeons to make an optimally clinical decision in economic perspective.
In recent decades, surgery for treating calcaneus fractures has showed that it can bring great cost-effectiveness compared with nonoperative treatments. For both surgeons and patients, they have high requirements of satisfaction on clinical outcomes and cost-effectiveness due to the advancement of medicine and therefore, costs are a crucial factor during making clinical decision. Cost-analysis is attached great significance of making clinical decision and is frequently used to evaluate which intervention can offer figure through comparing the cost and health impact of interventions.39 Thus, surgeons are supposed to make full assessments of costs and take benefits into consideration when making clinical strategy to manage specific patients.41
An article published in 2017 has used pooled data of western country to compare the cost and benefits in patients with calcaneus fractures classified as Sanders type II/III, which were managed with surgeries via extensile lateral approach or sinus tarsi approach or non-operative treatments . It demonstrated that ORIF via STA is the least expensive option for treating Sanders type II/III concerning total costs, probability of working the same job and duration out of work after ORIF. However, previous study did not conduct systematic retrospective review and report itemized details of the costs, which may hamper the ability to draw firm conclusions about cost-effectiveness by limited data. Moreover, long-term results after newer or refine ORIF techniques are unknown. In our study, we collected and checked the medical bills from single information center of all patients in order to conduct a Cost-Analysis.
In this retrospective view, only direct health costs were collected, and for the indirect health costs including miss time from work or decreased productivity, rehabilitation, further consultation and transportation were not calculated. CUA can be performed even without indirect costs. 14, 20, 47 According to the results, we found no statistical differences in total costs, laboratory and radiographic evaluation expense, surgical expenses, antibiotic drugs expense, anesthesia expense and the length of hospital stay. Our study found significant differences in the analgesia expenses and internal fixation materials costs. The costs of patients in ELA group were higher than the cost of patients in STA group $145.8 ± 85.6 versus $102.9 ± 62.7, P=.080). Patients underwent surgical treatment via ELA have caused much more severe injury to soft tissue and blood vessels comparing with STA. Owing to the larger wound caused by ELA, patients’ complaints of pain in the ELA group were more obvious. According to the pain measurement and VAS scores, there did exist significant difference in scores at 3 days and 5 days after surgery. Therefore, clinical strategies were made including using more effective analgesic drugs or extending the time of applying analgesic drugs, which resulted in the statistical difference in the expense of analgesia between these two groups. However, after postoperative treatments and caring, there showed no significant difference in VAS scores at 7 days after surgery.
Concerning the surgeon opinion for both technique, surgeon A could master ELA and STA techniques proficiently while surgeon B prefers performing ELA technique and surgeon C prefers performing STA technique. Additionally, patients’ specific condition and subjective wishes are supposed to be taken into consideration and therefore, there were no significant difference among surgeon rating for both surgical techniques to reconstruct the height, width, Bohler’s and Gissane angle of the calcaneus, therefore reaching the anatomical reduction. In this study, the brand of materials used in ELA group consists of Smith & nephew (29/62), Acumend (10/62) and Double medical technology Inc-China (23/62) while in STA group consists of Acumed (31/47) and Carefix-China (16/47). Normally, the option of choosing which type of plates mainly depend on patients’ condition and surgeon’s preferences. However, healthcare system varies in different countries and it can be assumed that there is some bias in choosing internal fixation materials based on patient income and insurance type. When conditions permit, surgeons provide patients with suggestions on therapeutic scheme patients and patients can choose imported or domestic internal fixation materials according to their financial status and wishes. Currently, domestic internal fixation materials have a price advantage and can reach similarly anatomical reduction with low complication rate compared with imported ones. In our study, the patients in the ELA group underwent ORIF with plates and five to eight 3.5-mm screws while the patients in the STA group underwent ORIF with three to four 6.5-mm cannulated screws solely. In the past 20 years, the technique of STA has been introduced in China and there were no comparable implants to match it and therefore this technique has not been popularized. Currently, as new generation of implants emerge, more and more surgeons tend to perform minimal invasive incisions and the cost of these implants are comparable to plates system in extensile lateral technique. Whether plate system or screws are applied via two different approaches, there were no definite indications for it. Based on our experience, normally procedures via ELA do not apply with screws solely and procedures via STA do not apply with large plates. We tend to apply screws for patients with intact calcaneal wall and simple posterior calcaneal articular surface collapse. For those patients with factures of calcaneal anterior process or impingement of fracture fragments, we tend to apply plate systems to reach anatomic reduction. The selection of implants is based on the specific condition of each patients and we control other parameters including patients’ information and fracture type and that is the way we justified the cost of the patients.
As for the life of various type of implants, normally the implants will be removed if situations including pain, infections and etc. happen. In our countries, a majority of patients choose to have their implants removed as long as the fracture site reaches clinical healing standard or 24 months after the surgery. However, it may not be possible to track and analyze the cost of removal internal fixations for it may not be performed in the same hospital.
In our study, no severe complications occurred and all the patients at final follow up observations showed an excellent therapeutic effect after surgery according to direct measurement of clinical outcomes. As the results showed that there were no significant differences between the ELA and STA group among different surgeons on the clinical efficacy indicators. Changes in pre- and postoperative VAS and AOFAS scores are both the most direct measurement and rapid evidence of surgical outcomes. Altogether, the application of surgical incision on ELA or STA among surgeon A, B and C depends on their own experience and preference. According to the clinical indicators, both incisions have comparative curative effects and equivalent precision ratio on patients with type II/III calcaneus fracture because there were no significant differences. They can alleviate patients’ pain and enable them to take their own responsibilities in the society.
The outcome of CUA was presented with gained QALYs, which were enumerated through multiplying the length of hospital stay by HRQoL weight (i.e, utility score) scaled from -0.11 to 1.00.40 Direct elicitation methods, generic preference-based measures, and condition-specific measures were used to evaluate HRQoL. The EQ-5D-3L, regarded as the primary valuation study derived utility scores, are prevalently applied preference-based measures. 9, 15, 33 In this study, CER and ICERs were the outcomes of economic benefits, which could be comprehended that ICERs indicate how much extra health benefits via ELA can bring compared with via STA, and how much additional expense it will cost.
Consequently, we found no statistically significant differences in overall cost per patient and HRQoL between two groups but generally surgery via ELA incurred much costs than via STA. Similarly, the incremental cost-utility ratio also showed there were no cost-utility benefits comparing two groups.