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Assessment of knee laxity using a robotic testing device: a comparison to the manual clinical knee examination.

ABSTRACT: The purpose of this study was to collect knee laxity data using a robotic testing device. The data collected were then compared to the results obtained from manual clinical examination.Two human cadavers were studied. A medial collateral ligament (MCL) tear was simulated in the left knee of cadaver 1, and a posterolateral corner (PLC) injury was simulated in the right knee of cadaver 2. Contralateral knees were left intact. Five blinded examiners carried out manual clinical examination on the knees. Laxity grades and a diagnosis were recorded. Using a robotic knee device which can measure knee laxity in three planes of motion: anterior-posterior, internal-external tibia rotation, and varus-valgus, quantitative data were obtained to document tibial motion relative to the femur.One of the five examiners correctly diagnosed the MCL injury. Robotic testing showed a 1.7° larger valgus angle, 3° greater tibial internal rotation, and lower endpoint stiffness (11.1 vs. 24.6 Nm/°) in the MCL-injured knee during varus-valgus testing when compared to the intact knee and 4.9 mm greater medial tibial translation during rotational testing. Two of the five examiners correctly diagnosed the PLC injury, while the other examiners diagnosed an MCL tear. The PLC-injured knee demonstrated 4.1 mm more lateral tibial translation and 2.2 mm more posterior tibial translation during varus-valgus testing when compared to the intact knee.The robotic testing device was able to provide objective numerical data that reflected differences between the injured knees and the uninjured knees in both cadavers. The examiners that performed the manual clinical examination on the cadaver knees proved to be poor at diagnosing the injuries. Robotic testing could act as an adjunct to the manual clinical examination by supplying numbers that could improve diagnosis of knee injury.Level II.

SUBMITTER: Branch TP

PROVIDER: S-EPMC5522506 | biostudies-other | 2017 Aug

REPOSITORIES: biostudies-other

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Project description:BackgroundBiomechanical measurement tools have been developed and widely used to precisely quantify knee anterior-posterior laxity after anterior cruciate ligament (ACL) injury. However, validated objective device to document knee rotational laxity, though being developed by different researchers, are not yet widely used in the daily clinical practice. A new biomechanical device was developed to quantify knee internal and external rotations.MethodsThe reliability of the new biomechanical device which measures knee rotations were tested. Different torques (1-10Nm) were applied by the device to internally and externally rotate human cadaveric knees, which were held in a flexion angle of 30°. The rotations were measured by the device in degrees. There were two independent testers, and each tester carried out three trials. Intra-rater and inter-rater reliability were quantified in terms of intraclass correlation (ICC) coefficient among trials and between testers. The device was verified by the comparison with a computer assisted navigation system. ICC was measured. Mean, standard deviation and 95% confident interval of the difference as well as the root mean square difference were calculated. The correlations were deemed to be reliable if the ICC was above 0.75.ResultsThe intra-rater and inter-rater reliability achieved high correlation for both internal and external rotation, ranged from 0.959 to 0.992. ICC between the proposed meter and the navigation system for both internal and external rotation was 0.78. The mean differences were 2.3° and 2.5° for internal and external rotation respectively.ConclusionsA new knee rotational laxity meter was proposed in this study. Its reliability was verified by showing high correlation among trials. It also showed good correlation to a gold standard of measurement. It might be used to document knee rotational laxity for various purposes, especially after ACL injury, after further validation of the device in human subjects.

Project description:BackgroundRobotic-arm-assisted knee arthroplasty allows for more accurate component positioning and alignment and is associated with better patient-reported outcomes compared to manually performed jig-based knee arthroplasty. However, what is not known is whether the addition of an intra-articular sensor (VerasenseTM) to aid intraoperative balancing of the total knee replacement (TKR) offers improved functional outcomes for the patient. The purpose of this research is to compare the outcomes of patients undergoing a conventional manual knee replacement to those undergoing TKR using robotic-assisted surgery and the VerasenseTM to optimise alignment and balance the knee joint, respectively, and assess the associated cost economics of such technology.Methods and analysisThis randomised controlled trial will include 90 patients with end-stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the inclusion/exclusion criteria that consent to be in the study will be randomised at a ratio of 1:1 to either manual TKR (standard of care) or robotic-arm-assisted TKR with VerasenseTM to aid balancing of the knee. The primary objective will be functional improvement at 6 months following surgery between the two groups. The secondary objectives are to compare changes in knee-specific function, joint awareness, patient expectation and fulfilment, satisfaction, pain, stiffness and functional ability, health-related quality of life, cost-effectiveness, and gait patterns between the two groups. Ethical approval was obtained by the Tyne & Wear South Research Ethics Committee, UK. The study is sponsored by the Newcastle Hospitals NHS Foundation Trust.DiscussionThis study will assess whether the improved accuracy of component positioning using the robotic-arm-assisted surgery and the VerasenseTM to aid balancing of the TKR offers improved outcome relative to standard manual jig-based systems that are currently the standard of care. This will be assessed primarily according to knee-specific function, but several other measures will also be assessed including whether these are cost-effective interventions.Trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN47889316 https://doi.org/10.1186/ISRCTN47889316 . Registered on 25 November 2019 DATE AND VERSION FOR PROTOCOL: ROAM Protocol V1.0 (13-12-2018).

Project description:BackgroundNPM1 mutation status can influence prognosis and management in AML. Accordingly, clinical testing (i.e., RT-PCR, NGS and IHC) for mutant NPM1 is increasing in order to detect residual disease in AML, alongside flow cytometry (FC). However, the relationship of the results from RT-PCR to traditional NGS, IHC and FC is not widely known among many practitioners. Herein, we aim to: i) describe the performance of RT-PCR compared to traditional NGS and IHC for the detection of mutant NPM1 in clinical practice, and also compare it to FC, and ii) provide our observations regarding the advantages and disadvantages of each approach in order to inform future clinical testing algorithms.MethodsPeripheral blood and bone marrow samples collected for clinical testing at variable time points during patient management were tested by quantitative, real-time, RT-PCR and results were compared to findings from a Myeloid NGS panel, mutant NPM1 IHC and FC.ResultsRT-PCR showed superior sensitivity compared to NGS, IHC and FC with the main challenge of NGS, IHC and FC being the ability to identify a low disease burden (<0.5% NCN by RT-PCR). Nevertheless, the positive predictive value of NGS, IHC and FC were each ≥ 80% indicating that positive results by those assays are typically associated with RT-PCR positivity. IHC, unlike bulk methods (RT-PCR, NGS and FC), is able provide information regarding cellular/architectural context of disease in biopsies. FC did not identify any NPM1-mutated residual disease not already detected by RT-PCR, NGS or IHC.ConclusionOverall, our findings demonstrate that RT-PCR shows superior sensitivity compared to a traditional Myeloid NGS, suggesting the need for "deep-sequencing" NGS panels for NGS-based monitoring of residual disease in NPM1-mutant AML. IHC provides complementary cytomorphologic information to RT-PCR. Lastly, FC may not be necessary in the setting of post-therapy follow up for NPM1-mutated AML. Together, these findings can help inform future clinical testing algorithms.

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Assessment of knee laxity using a robotic testing device: a comparison to the manual clinical knee examination.

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