A novel digital arthrometer to measure anterior tibial translation: A Quantitative Study

doi:10.21203/rs.3.rs-2237203/v1

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Research Article

A novel digital arthrometer to measure anterior tibial translation: A Quantitative Study

https://doi.org/10.21203/rs.3.rs-2237203/v1

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Journal Publication

published 13 Feb, 2023

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Background

Measurement of knee laxity after anterior cruciate ligament (ACL) injury is crucial for appropriate treatment and rehabilitation decision-making. This study examined the potential of a new digital arthrometer (Ligs, Innomotion, Shanghai, China) to quantify anterior tibial translation (ATT) in patients with ACL injuries and in healthy subjects.

Methods

A total of 60 participants included 30 subjects with single-leg ACL injuries and 30 healthy subjects included as controls. The lower leg was immobilized and a thrust under a dynamic load of 0–150 N was gradually applied posteriorly, with continuous displacement recorded. ATT and side-to-side differences (SSD) between the control and ACL injury groups were compared. Receiver operating characteristic (ROC) curves were analyzed, and the area under the curve (AUC) was calculated to determine the diagnostic accuracy of the Ligs.

Results

The interrater ICC was 0.909 and the intrarater ICC was 0.943. Significant differences in the SSD were observed between the control and ACL injury groups (for all P < 0.05), with the largest effect size (ES = 1.12) at 80 N. When comparing ATT at different loads between injured and healthy sides in the ACL injury group, displacement was statistically significant at different loads. At a load of 150 N, the AUC was the maximum (0.857) and the sensitivity and specificity were 0.87 and 0.73, respectively.

Conclusions

Knee laxity

anterior tibial translation

digital arthrometer

anterior cruciate ligament

quantitative study

The basic function of the anterior cruciate ligament (ACL) is to limit excessive anterior displacement and valgus rotation of the tibia relative to that of the femur. ACL injuries are frequently observed (Gianotti et al., 2009) however, standards guiding the decision of whether to operate after an ACL injury have not been clearly defined( Monk et al., 2016, Krause et al., 2018, Rodriguez et al., 2021), and there are no evidence-based arguments to recommend that either conservative or surgical treatment provides better functional outcomes. Furthermore, knee laxity after ACL injury can be compensated for by muscle strengthening and neuromuscular proprioceptive exercises (Elbaz et al., 2014). Increasing knee laxity may be an early signal of knee decompensation and structural damage when compensatory mechanisms have been triggered (Macchiarola et al., 2022). Therefore, a simple and objective approach to following up patients with ACL injuries is by evaluating knee laxity.

Physical examination is commonly used to assess knee laxity, although the condition cannot be quantified by physical examination alone. Recently, several devices have been introduced to quantify anterior tibial translation (ATT) that can be widely used to objectively assess knee laxity (Robert et al., 2009, Panisset et al., 2012; Raggi et al., 2019). For example, the KT1000 (Medmetric Corp, San Diego, CA, USA) device has also been used extensively to assess knee laxity after ACL injury (Rangger et al., 1993). Wiertsema et al. (Wiertsema et al., 2008) compared the reliability of the KT1000 device with that of the Lachmann test in individuals with ACL rupture. The reliability of the KT1000 was lower than that of the Lachman test, with intraclass correlation coefficient (ICC) for both intrarater (1.0 vs 0.47) and interrater (0.77 vs 0.14) reliability and repeated measurements of the KT1000 arthrometer in a single measurement session showing inadequate reliability. Runer et al. tested the inter- and intrarater reliability of four different knee arthrometers (KLT, Karl Storz; KiRA, I+; KT-1000, Medmetric Corp; Rolimeter, Aircast) in healthy patients and obtained ICC ranging from 0.49–0.70 (Runer et al., 2021). Thus, easy-to-use and accurate instruments to quantify knee laxity are currently not available.

Recently, a new digital arthrometer was developed to optimize the quantification of knee laxity in terms of its size and operation. The Ligs (Innomotion, Shanghai, China) is a portable, non-invasive device for joint laxity testing consisting of a main frame and a fixing bracket. The frame has built-in sensors that continuously record the real-time load and displacement, and the limit bracket is primarily used to fix the body position (Fig. 1B). Chen et al. used the Ligs device to quantify anterior drawer testing (ADT) in chronic ankle instability with satisfactory results (Chen et al., 2022). However, the feasibility of quantifying ATT using this device has not yet been analyzed.

Therefore, the purpose of this study was to investigate whether the Ligs device has the potential to quantify knee laxity. Since patients with ACL injuries have significantly higher ATT than healthy individuals, ATT was compared in healthy and ACL-injured knees to determine differences in quantification parameters, and intra- and interrater reliability. Our hypothesis was that the Ligs device would be able to objectively quantify knee laxity.

The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee (No.102772021RT040 of our institution). All participants signed an informed consent form prior to the start of the study.

Participants

A total of 60 participants including 30 with single-leg ACL injuries (30 injured knees, 30 healthy knees) and 30 healthy subjects (60 healthy knees) to be used as controls were enrolled.

Participants in the ACL injury group were diagnosed with isolated and complete ACL rupture by a sports medicine specialist based on clinical symptoms and magnetic resonance imaging results. The inclusion criteria were as follows: (i) single-leg ACL injury, (ii) complete ACL rupture, (iii) preparation for ACL reconstruction surgery after examination, (iv) Lachman test (+), and (v) body mass index (BMI) < 30. The exclusion criteria were: (i) age < 18 or > 45 years, (ii) ACL injury in both knees, (iii) limitation of knee motion (knee flexion limitation), (iv) chronic ACL injury (> 3 months after injury), and (v) BMI ≥ 30.

Participants in the control group satisfied the following conditions: (i) no previous history of knee pain or knee surgery; (ii) no injury to the muscles, tendons, ligaments or cartilage around the knee; (iii) no degenerative knee disease; and (iv) BMI < 30.

Experimental Process

All subjects were required to be free of strenuous activity for 48 h prior to examination and wore black shorts during testing. Subjects were placed in a lateral position with the bilateral lower limbs exposed and the knees flexed at 30° simulating the Lachman test position. The components on one side of the fixator were placed anterior to the patella, and on the other side distal to the tibia. Subsequently, a pushing force was gradually applied from the posterior of the tibia. The thrusters at the end of the main frame were set at a constant speed (3N/s) to apply a thrust from the back of the lower leg, causing anterior displacement of the tibia (Fig. 1A). To mitigate the effects of muscle tissue, the displacement was recorded when the pressure exceeded 20 N and an alarm was sounded when the force reached the set value. In this study, the upper load threshold was set at 150 N. In a previous study, Bercovy et al. (Bercovy and Weber, 1995) found that the minimum load for an accurate diagnosis of ACL rupture was 180 N. In our pre-test findings, three control subjects were unable to reach this threshold. Furthermore, the KT1000 selected 134 N as the maximum threshold for examination. Therefore, 150 N was selected as the maximum threshold. Displacements corresponding to fixed loads of 80 N, 120 N, and 150 N were recorded. The accuracy of load was 1 N and the displacement was 0.1 mm. All measurements were conducted three times, and the average value was recorded.

Data Analysis

The interrater reliability was tested for two independent examiners using the same group of ten healthy subjects. The intrarater reliability was tested by the same examiner at three different time points (1-hour intervals between the three tests). Both inter- and intrarater reliability was tested by measuring ATT values using the Ligs device. An ICC greater than 0.74 was considered excellent, an ICC between 0.60 and 0.74 was considered good, an ICC between 0.40 and 0.59 was considered fair, and values less than 0.40 were considered poor as in a previous study (Cicchetti and Sparrow, 1981).

The difference in side-to-side differences (SSD) between the control and ACL injury groups under different loads was compared. The difference in ATT between the healthy and injured sides in the ACL injury group was compared under loads of 80 N, 120 N, and 150 N. Effect sizes were calculated and compared. Cohen's d effect size classification was defined 0.2 as small, 0.5 as medium, and 0.8 as a large effect (1990). The loading condition had a higher diagnostic value.

Statistical analysis

Statistical analysis was performed using IBM SPSS software (version 23.0, Armonk, NY, USA). The ICC was calculated to test the intra- and interrater reliability. Testing of whether the ATT and SSD values conform to the normality distribution was performed by the Kolmogorov-Smirnov test. An independent sample t-test was used to compare the control and ACL injury groups with the SSD. A paired sample t-test was used to compare the mean ATT of the ACL injury group on the healthy and injured sides. Receiver operating characteristic (ROC) curve analysis was used to calculate the area under the curve (AUC) and to determine cut-off values for the control and ACL injury groups. Sensitivity and specificity were also calculated. The significance level was set at P < 0.05.

Demographics

The characteristics of the subjects were compared between the control and ACL injury groups (Table 1). There were no statistically significant differences with regard to sex (P = 0.176), with the control group being 56% males and the ACL injury group being 73% of males. There were no statistically significant differences in age between the groups (P = 0.198). In the ACL injury group, the right side was involved more often, accounting for approximately 67% of the total number of injuries. There were no statistically significant differences in BMI (P = 0.791).

Inter- and Intrarater reliability assessment

The interrater reliability was considered valid with an ICC score of 0.909 (95% CI, 0.853–0.945) and a mean measured value of 0.953 (95% CI, 0.921–0.972). The intrarater reliability was considered valid with an ICC score of 0.943 (95% CI, 0.918–0.961) for a single metric and a mean measure of 0.971 (95% CI, 0.957–0.980).

Reference standard comparisons

Comparison of SSD under different loads in the control and ACL injury groups showed that differences in SSD at 80 N, 120 N, and 150 N were statistically significant (all P < 0.01). The largest effect size was observed at a load of 80 N (effect size = 1.12, Table 2).

When comparing ATT at different loads between injured and healthy sides in the ACL injury group, displacement was statistically significant at 80 N, 120 N, and 150 N (all P < 0.001) (Fig. 2). The largest effect size was observed at a load of 150 N (effect size = 1.40, Table 3). The curves indicating typical load-displacement changes in healthy and injured knees are shown in Fig. 3. Compared with the healthy side, the curve on the injured side was steeper, indicating greater laxity.

Diagnostic accuracy

A load of 150 N produced the maximum AUC (0.857, 95%CI [0.761–0.954]), the cut-off value was set to 19.7 mm, and the sensitivity and specificity were 0.87 and 0.73, respectively. The ROC curves for the different loads are shown in Fig. 4.

In this study, the results showed excellent inter- and intrarater reliability (ICC scores of 0.909 and 0.943, > 0.75, defined as excellent) for measuring ATT values using the Ligs device, which indicates its suitability for the diagnosis of ACL. Meanwhile, there were significant differences in ATT and SSD under different loads in both the ACL injury and the control groups. Our study confirmed our hypothesis that digital arthrometry could be used as a tool for the quantitative assessment of knee laxity.

It is essential to assess knee laxity after an ACL injury. ACL injuries are, in most cases, noncontact injuries, and the cause of the injury is mostly rotation of the joint during sports activities (Boden et al., 2000). With persistent knee laxity, the position of the tibial cartilage contact point changes (Li et al., 2006),and the axis of tibial rotation shifts (Amis et al., 2005). These changes alter the path of flexion of the medial femoral condyle and subsequently increase the risk of secondary injury to the medial meniscus (Jiang et al., 2012). Furthermore, the evaluation of knee laxity after ACL injury is important in deciding the treatment plan. Magnussen et al. (Magnussen et al., 2018) found that individuals with greater preoperative knee laxity were significantly more likely to undergo ACL revision surgery in the following 6 years. Additionally, Knee laxity is associated with a high risk of ACL reconstruction failure (Alm et al., 2020). In a study evaluating factors influencing meniscal injury during ACL reconstruction, Nakamae et al. (Nakamae et al., 2022) found that the high incidence of meniscal injuries was closely related to the high laxity of the knee joint and was more prevalent in men. Therefore, it is of great clinical importance to develop a simple method that can quantitatively and accurately assess knee laxity after ACL injury.

The Lachman test (30° stress physical examination) is a screening tool commonly used by clinicians with high sensitivity (94%) and specificity (83%) (Mulligan et al., 2015). However, the results of the Lachman test can be influenced by the clinical experience of the examiner as well as their subjective perceptions (Leblanc et al., 2015). Further, the Lachman test does not provide any quantitative indicators, and it is neither practical nor widely available to inexperienced physicians and sports rehabilitation practitioners.

The KT1000 arthrometer is the most common instrument for measuring ATT and has been reported to be suitable for the diagnosis of ACL injuries because of its high sensitivity (92%) and specificity (95%) ( Highgenboten et al., 1989; Bach et al., 1990; Torzilli et al., 1991; Ballantyne et al., 1995; Amis et al., 2003). However, Forster et al. (Forster et al., 1989) found significant inter- and intrarater variability (ICC = 0.14 and 0.47) in measurements of ATT and SSD using the KT1000. In the study by Sernert et al. (Sernert et al., 2007), the KT-1000 was used to analyze and compare knee laxity between left- and right-handed dominant physical therapists in patients with ACL injuries. Left hand-dominant therapists obtained significantly higher values for left knee laxity. The device we used applied the load uniformly (3N/s) through a hand crank at the end of the mainframe (Fig. 1B). The test results were not affected by the dominant hand. The Telos device (GmbH, Hungen, Germany) is widely used as a mobile stress stent in conjunction with X-rays to diagnose ACL injuries, and showed a sensitivity of 86.0% and a specificity of 89.2% at 30° for knee flexion using 3 mm as the threshold value (Lee et al., 2019). However, radiation exposure is its main drawback. The Ligs is a portable, noninvasive, nonradiation-dependent, quantitative examination device with excellent reliability.

The Ligs device quantifies ATT using built-in sensors, recording loads and displacements in real time. Our study showed ICC of 0.909 and 0.943 for inter- and intrarater, respectively, confirming the reliability of applying Ligs to detect knee laxity after ACL injury. Furthermore, the results of the Ligs test are quantitative indicators that can reduce experiential dependence. The Ligs device was also used by Chen et al. for the assessment of chronic ankle instability and was found to have excellent intra- and interrater reliability with ICCs of 0.963 and 0.949, respectively (Chen et al., 2022). Moreover, there are currently no reports evaluating knee laxity detected by Ligs.

In our study, the mean SSD for the ACL injury group was 2.7 mm at 80 N, with a maximum AUC of 0.782 (95% CI, 0.666–0.898) and an effect size of 1.12. The results indicated that the presence of ACL injuries could be identified using SSD at lower loads. We recommend the use of 80N as the optimal load to quantify the diagnosis of ACL injury to prevent discomfort in the patient. A larger SSD decreases the sensitivity of the diagnosis; however, its specificity is significantly higher, effectively reducing false-positive cases. The mean SSD of healthy participants in the control group was 1.2 mm. Niu et al. (Niu et al., 2022) used an automatic knee arthrometer to measure knee laxity after ACL injury and found that SSD was less than 1.5 mm in healthy participants. We infer that SSD in healthy individuals is less than 1.5 mm.

In the ACL injury group, the ATT of the healthy and injured sides at different loads were statistically significant (P < 0.05). With increasing load, the mean ATT value at 150 N had a maximum AUC of 0.857. The cut-off value was set at 19.7 mm with sensitivities and specificities of 0.87 and 0.73, respectively. A large effect size was observed at a load of 150 N (effect size = 1.40). This result suggests that the ACL injury is indicated when the ATT exceeds 19.7 mm under a load of 150 N. Furthermore, Keizer and Otten (Keizer and Otten, 2019) in their review concluded that the mean ATT was lower in controls (5.96 mm) and in the healthy contralateral side (5.33 mm) than in the ACL-injured knees (9.15 mm), which was also confirmed by our findings.

This study has several limitations. The participants were limited to patients with simple ACL injuries, and thus further in-depth studies should be conducted to include patients with different types of ACL injuries and to differentiate population characteristics. More accurate diagnostic criteria can be refined by including different subject populations to obtain enriched ATT data.

A digital arthrometer can be used as a quantitative instrument to quantify knee laxity. Quantitative measurement of ATT and SSD under controlled loading can be an objective and effective tool applicable to clinical practice, and ACL injuries can be identified by SSD at lower loads. The highest diagnostic accuracy of SSD under an 80 N load and ATT under a 150 N load can provide an objective scientific basis for to aid in the diagnosis of ACL injury in the clinical setting.

ACL, anterior cruciate ligament

ATT, anterior tibial translation

SSD, side-to-side differences

ICC, intraclass correlation coefficient

ROC, receiver operating characteristic

AUC, area under the curve

ADT, anterior drawer testing

BMI, body mass index

SD, standard deviation

CI: confidence interval

Ethics approval and consent to participate

The study was approved by the Ethics Committee (No.102772021RT040) of Institutional Review Board of Shanghai University of Sports.

Consent for publication

Not applicable.

Availability of data and materials

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing Interests

The authors declare that they have no competing interests.

Funding

This study was funded by a Key Basic Research Project of the Military Commission Basic Strengthening Program on motion biomechanics; Shanghai Outstanding Academic/Technical Leaders Program Funding (21XD1434800)

Author Contributions

Conceptualization: SW, DW, and YH; Methodology: DW, YZ, LG, LZ, JL, and ZZ; Formal analysis and investigation: YL, LG, LZ, YH, and DW; Writing—original draft preparation: DW and DW; Writing—review and editing: DW, SW, and DW; Funding acquisition: SW; Resources: SW; Supervision: SW.

Acknowledgments

This work was supported by a Key Basic Research Project of the Military Commission Basic Strengthening Program on motion biomechanics; Shanghai Outstanding Academic/Technical Leaders Program Funding (21XD1434800). The authors would like to thank the editors from Editage for their language services.

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Table 1

Subject demographic characteristics ^a
Variable	ACL injury group (n = 30)	Control group (n = 30)	P-value
Gender(M/F)	22/8	17/13	0.176
Age(Y)	23 ± 3.3	22 ± 3.0	0.198
Injured side (L/R)	13/17	-	-
BMI (kg/m²)	21.1 ± 2.1	20.9 ± 2.3	0.791
ACL: anterior cruciate ligament, BMI: body mass index, M: Male, F: Female, Y: Year, L: Left, R: Right
a Values are presented as mean ± standard deviation (SD); the level of significance was established a priori at P < 0.05.

Table 2

Comparison of SSD in the ACL injury group and the control group ^b
Variable	SSD of the ACL injury group (mm)	SSD of control group (mm)	P value	95%CI	Effect size
80N	2.7 ± 1.4	1.2 ± 1.1	0.000^***	0.77–2.07	1.12
120N	3.4 ± 2.2	1.7 ± 1.2	0.001^**	0.74–2.59	0.93
150N	3.8 ± 2.7	1.8 ± 1.3	0.001^**	0.92–3.17	0.94
SSD: side to side difference, ACL: anterior cruciate ligament, CI: confidence interval
b: Values are presented as mean ± standard deviation (SD); the level of significance was established a priori at P < 0.05.
*: P < 0.001, : P < 0.01

Table 3

Comparison of ATT on injured and on healthy sides in the ACL injury group ^c
Variable	ATT of injured side (mm)	ATT of healthy side (mm)	P-value	95%CI
80N	14.7 ± 2.2	12.6 ± 2.0	0.000^***	1.37–2.95	1.02
120N	19.5 ± 2.6	16.3 ± 2.4	0.000^***	2.34–4.12	1.28
150N	22.4 ± 2.8	18.6 ± 2.7	0.000^***	2.83–4.86	1.40
ATT: anterior tibial translation, ACL: anterior cruciate ligament, CI: confidence interval
c Values are presented as mean ± standard deviation (SD); the level of significance was established a priori at P < 0.05.
***: P < 0.001

No competing interests reported.

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published 13 Feb, 2023

Read the published version in Journal of Orthopaedic Surgery and Research →

Editorial decision: Major revision
08 Nov, 2022
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A novel digital arthrometer to measure anterior tibial translation: A Quantitative Study

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Background

Methods

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Results

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Inter- and Intrarater reliability assessment

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