Cadaveric specimens
This study was performed in accordance with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee (approval number: 2021-2431-Material). Ten pairs of fresh frozen intact lower legs were used (7 males, 3 females, mean age 87.1 years; range 74-94 years).
The specimens were lower legs from voluntary body donors from the Institute of Anatomy I of the University. Previous accidents or operations were not reported. Specimens were thawed at room temperature for 18 hours. Soft tissue in the malleolar region was removed, protecting the ligamentous portions. This included the ligamentous structures of the syndesmosis as well as the deltoid ligament in the medial malleolus region and lateral ligamentous structures in the lateral malleolus region.
Description of the developed STT
To be able to apply a standardized force and thus stress to the syndesmosis, a tool was developed in cooperation with the research workshop of the university (Figure 2). This consists of two metal plates which can be inserted in the space between the tibia and fibula. A spindle is built into the body of the tool, which in turn can be used to build up a defined force via a rotary wheel at the other end. A torque limiter can limit the maximum force to be applied via another wheel mounted at the end of the rotary wheel. Forces between 50-100 N can be set here. After the set force is reached, no further force is built up via the rotary wheel. The tool can thus be used to apply a force to be set between the fibula and the tibia. The metal plates and thus also the force vector are oriented slightly obliquely and thus in accordance with the orientation of the two bones to each other (about 45 degrees), with the fibula lying dorsal to the tibia (Figure 3).
Description of the intraoperative HT
A commercial portable digital scale was hooked to the fibula 2 cm proximal to the anterior syndesmosis. It was pulled horizontally (90 degrees to the fibula shaft axis) laterally on the fibula with the scale under constant control of the applied force.
Biomechanical evaluation of the syndesmotic diastasis
To record the induced diastasis between fibula and tibia by the forces applied in both tests, a 3D camera system of the Fraunhofer IOF was used (optical 3D measurement system »kolibri CORDLESS« with two stereo cameras of resolution 2048x1280 pixels, measurement uncertainty 20-100 µm, 30 frames per second for marker tracking). Two passive optical marker plates were applied to the distal fibula and tibia at the level of the syndesmosis. The marker plates consisted of three reflective spheres each and were labelled M1 (tibia) and M2 (fibula) (Figure 3). To perform the stress tests, the specimens were fixed proximally to the tibial plateau and distally to the foot. Initially, the stress tests were performed with the two tools on the intact lower legs, without destruction of the syndesmosis. Forces of 50, 80 and 100 N were applied in each test step. For this purpose, the STT was inserted 2 cm proximal to the level of the anterior syndesmosis between the fibula and the tibia and the rotary wheel was actuated until the torque sensor was triggered and the previously set force was reached. During this process, the change in diastasis or the movement of the two markers (M1 and M2) was recorded with the 3D camera system. The tests with the STT and the HT were performed one after the other. Which test was started with was randomized for the first sample and then alternated.
The right and left legs of each pair were randomly assigned to one of two groups (anterior to posterior or posterior to anterior). In the first step, all specimens were tested natively without injury to document the native diastasis of the syndesmosis as the initial condition. Steps 2.-5. follow as destabilization steps.
In the first group (anterior to posterior), stepwise instability of the syndesmosis was performed in the following protocol:
2. cutting of the anterior syndesmosis ligament (AITFL).
3. cutting of the intermediate syndesmotic ligament
4. osteotomy of the posterior tibial rim (bony fixation of the PIFTL)
5. cutting of the deltoid ligament.
The ligamentous structures were cut through a standard surgical scalpel. An oscillating saw was used to osteotomize the posterior malleolus.
In the second group (posterior to anterior), the protocol was performed in the reverse order as follows:
2. cutting of the deltoid ligament.
3. osteotomy of the posterior tibial rim (bony fixation of the PIFTL)
4. cutting of the intermediary syndesmotic ligament
5. cutting of the anterior syndesmotic ligament (AITFL)
After each of the four transection steps, a force was applied with the STT and the HT with 50, 80, and 100 N, respectively and one after the other. The change in diastasis was continuously monitored using a 3D camera. A relevant threshold value of relative motion between the two bones of > 2mm was determined. This value is based on a native physiological diastasis of about 1 mm in mediolateral direction, which is known from the literature [43-45].
The data bases regarding to the HT data, used in this work, has already been examined and published with regard to reliability [26].
Statistical methods
In a first step a general linear model (GLM) for repeated measures was used to detect the impact of the direction of stepwise induced instability. Therefore, as between subject factor the variable with the coded information of the direction of the stepwise performed instability (from anterior to posterior or from posterior to anterior) was used. The maximum diastasis, measured repeatedly provoked by the STT and the HT (device) during the applied force (3 level), the instability (5 level), was used as within subject factors (repeated measures). If the direction of stepwise induced instability showed no significance as a main effect and in the interaction effect, a second GLM was used, in which the direction is omitted to increase the power of the analysis.
If the Mauchly test for sphericity shows significance, the Greenhouse-Geisser p-value for the main and interaction effects (force and instability) is used. For the main effects (force, instability and device) additional to the p-value the effect sizes (ES) are given in partial eta square (p.Eta²). Values of 0.01, 0.06, or 0.14 indicate small, medium, or large effects, respectively [46]. Bonferroni corrected pairwise post hoc comparisons were used due to multiple testing and the resulting accumulation of alpha errors.
The post hoc pairwise comparisons between the levels of instability, separate for each device, are supplemented by Cohen's d [47] effect sizes in addition to the p-values for better differentiation and interpretation with d=0.2 small effects, d=0.5 moderate effect and d=0.8 large effect.
For visual comparison, the results are given as mean and 95% confidence intervals as error bars. This means that samples with non-overlapping error bars differ significantly, with p≤0.05.
The level of significance was set at p≤0.05. SPSS version 27 software (IBM Corp. Released 2020. IBM SPSS Statistics for Windows, Version 27.0. Armonk, NY: IBM Corp) was used for statistical analyses.