A comparison of the cost-effectiveness of intramedullary nail fixation and locking plate fixation in the treatment of adult patients with an extra-articular fracture of the distal tibia

Stallard

et al. 2022

BMC Med Res Methodol

Background Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. Methods Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. Results The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. Conclusions The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.

Section: Discussionmentioning

confidence: 99%

Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs

Stallard

et al. 2022

BMC Med Res Methodol

“…One of the limitations of this preliminary analysis is that this study does not provide a costutility analysis, considering the quality of life-adjusted life years (QALYs), which is regarded as an economically important aspect [9,26,27]. The present study can only be used to compare the insertion of pre-surgical ST in the Brazilian scenario with the usual protocol in the health system.…”

Section: Plos Onementioning

confidence: 99%

Cost analysis of photobiomodulation in tibia fracture in the Brazilian public health system

Jana Neto,

Martimbianco,

de Medeiros

et al. 2023

PLoS ONE

Managing tibial fractures requires substantial health resources, which costs the health system. This study aimed to describe the costs of photobiomodulation (PBM) with LEDs in the healing process of soft tissue lesions associated with tibial fracture compared to a placebo. Economic analysis was performed based on a randomized controlled clinical trial, with a simulation of the cost-effectiveness and incremental cost model. Adults (n = 27) hospitalized with tibia fracture awaiting definitive surgery were randomized into two distinct groups: the PBM Group (n = 13) and the Control Group with simulated phototherapy (n = 14). To simulate the cost-effectiveness and incremental cost model, the outcome was the evolution of wound resolution by the BATES-JENSEN scale and time of wound resolution in days. The total cost of treatment for the Control group was R$21,164.56, and a difference of R$7,527.10 more was observed when compared to the treatment of the PBM group. The proposed intervention did not present incremental cost since the difference in the costs to reduce measures between the groups was smaller for the PBM group. When analyzing the ICER (Incremental cost-effectiveness ratio), it would be possible to save R$3,500.98 with PBM and decrease by 2.15 points in the daily average on the BATES-JENSEN scale. It is concluded, therefore, that PBM can be a supportive therapy of clinical and economic interest in a hospital setting.

OTA International: The Open Access Journal of Orthopaedic Trauma

“…Intramedullary nailing of distal tibial fractures has several proposed benefits compared to ORIF including cost efficacy, [19,20] shorter operating and radiation time, [13,21] and decreased soft tissue disruption leading to more favorable local biology for fracture union and wound-related complications. [6,[12][13][14]21,22] One of the primary benefits of long bone fracture treatment with IMN is the facilitation of immediate weight bearing due to the biomechanical load sharing nature of intramedullary devices.…”

Section: Management With Intramedullary Nailingmentioning

confidence: 99%

Extreme nailing and immediate weight bearing constructs in fractures of the distal tibia

John

Mir

2022

Extraarticular fractures of the distal tibia can present as difficult but manageable lower extremity injuries. Historically, these injuries have been fixed in a myriad of ways. Early management with intramedullary nailing had higher complication rates due to the unique anatomical and biomechanical features of the distal tibia. Modern improvements in intramedullary nailing surgical techniques and implant design have significantly decreased complication rates and led to improvement in patient outcomes. Many surgeons protect weight bearing postoperatively, but recent literature suggests that patients may safely weight bear immediately following intramedullary fixation. This article reviews technique and implant design changes that have facilitated immediate safe weight bearing following intramedullary nailing of extraarticular distal tibia fractures.