Knee Kinesiography for Anterior Knee Pain
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Womack Army Medical Center
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This is a randomized clinical trial investigating the use of the Emovi Knee Kinesiography information in the treatment of anterior knee pain in physical therapy.
How does the Emovi 3D Knee Assessment Device treatment differ from other treatments for anterior knee pain?
The Emovi 3D Knee Assessment Device, also known as KneeKG, is unique because it provides a detailed three-dimensional analysis of knee movement, which helps in accurately diagnosing and evaluating knee conditions. Unlike traditional methods, it uses a non-invasive exoskeleton attachment system to reduce errors caused by skin movement, offering a more precise assessment of knee joint motion.
13568Is the KneeKG system safe for use in humans?
The KneeKG system is designed to provide reliable movement analysis of the knee joint, and there is no indication of safety concerns in the literature reviewed.
3671012What data supports the effectiveness of the treatment Emovi 3D Knee Assessment Device, KneeKG, Knee Kinesiography System for anterior knee pain?
The research suggests that using standardized gestures can improve the accuracy of 3D knee movement measurements, which may enhance the effectiveness of treatments like the Knee Kinesiography System by providing more reliable data on knee function.
245911Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for active duty service members aged 18-50 stationed at Fort Liberty and Schofield Barracks, diagnosed with patellofemoral pain. It's not open to those with a history of traumatic knee injury, rheumatoid or neurological diseases, previous knee surgery, other lower limb injuries, individuals moving from the station within three months, or pregnant women.Inclusion Criteria
I am between 18 and 50 years old.
I have been diagnosed with knee pain.
Exclusion Criteria
I have had a serious knee injury, like a torn ligament or meniscus.
I have rheumatoid arthritis or a neurological condition.
I have had knee surgery in the past.
I have a current injury to my lower limb, like an ankle sprain.
Participant Groups
The study tests if using Emovi Knee Kinesiography—a device that assesses knee movement—helps in treating anterior knee pain during physical therapy. Participants are randomly chosen to either receive this new assessment tool or continue with standard care.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention: Knee KG informed physical therapyExperimental Treatment1 Intervention
Participants in this group will receive care guided by the impairments identified with the KneeKG. The KneeKG exam results in recommended exercises that target the specific biomechanical impairments identified. The exercises and dose given to the participant will be based on what the KneeKG device recommends after the exam. The participant will be seen twice a week for 4 weeks.
Group II: Control: Standard of care physical therapyActive Control1 Intervention
Participants in this arm will have their KneeKG data captured, but this information will not be provided to the physical therapist to inform their care. Instead, physical therapists will deliver care as they normally do in routine clinical practice. The participant will be seen twice a week for 4 weeks.
Emovi 3D Knee Assessment Device is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as KneeKG for:
- Assessment of knee motion for patients with impaired movement functions of an orthopedic cause
🇨🇦 Approved in Canada as KneeKG for:
- Assessment of knee motion for patients with impaired movement functions of an orthopedic cause
🇪🇺 Approved in European Union as KneeKG for:
- Assessment of knee motion for patients with impaired movement functions of an orthopedic cause
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Womack Army Medical CenterFort Liberty, NC
Tripler Army Medical CenterHonolulu, HI
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Who is running the clinical trial?
Womack Army Medical CenterLead Sponsor
Medical Technology Enterprise ConsortiumCollaborator
The Geneva FoundationCollaborator
References
Three-dimensional knee analyzer validation by simple fluoroscopic study. [2019]Introduction: The complexity of the knee articulation makes its clinical evaluation extremely difficult. Insufficiency of existing instruments for knee evaluation prevents physicians from providing a diagnosis of injury and/or an evaluation of different treatments. To this end, our research group has developed a functional knee analyzer, which allows a three-dimensional evaluation of the knee in motion. The goal of this study is to scientifically validate the functional knee analyzer before using it in clinical setting. Materials and methods: The three-dimensional knee analyzer includes an orthoplastic exoskeleton attachment system, a kinematic tracking device, a screen for graphical display and a C(++) program with a user interface for calculating kinematic indices. A fluoroscopic study was performed on five healthy subjects with a mean age of 28. The experiment was set-up to determine the reduction of skin movement with respect to the underlying bone by using a knee exoskeleton attachment system. The root mean square (RMS) errors of markers movement about the abduction-X (RMSRx) and tibial rotation-Z (RMSRz) axes and displacement in the XZ plane (RMSpxpz) were calculated, once by placing markers directly on the skin and once on the exoskeleton attachment system. Results: Our results demonstrated that RMSpxpz, RMSRx and RMSRz were reduced by a factor of 6 (min 1.8, max 26), 4.3 (min 0.75, max 21) and 6.2 (min 2, max 26.4) on average, respectively, for four subjects out of five when the exoskeleton attachment was used.
Gesture standardization increases the reproducibility of 3D kinematic measurements of the knee joint. [2019]The literature on the 3D kinematics of the knee suggests that the gesture accomplished during kinematic assessment might play a significant role in the values measured. The purpose of this study is to demonstrate that a standardized gesture leads to an increased reproducibility in 3D kinematic measurements of the knee.
Description and validation of a navigation system for intra-operative evaluation of knee laxity. [2022]This paper describes the features of KIN-nav, a navigation system specifically dedicated to intra-operative evaluation of knee laxity, and assesses the reliability of the system during surgery. The acquisition protocol for its intra-operative use, the original user interface, and the computational methods for elaboration of kinematic data are described in detail. Moreover, an extensive and specific validation of the system was performed in order to evaluate its intra-operative performance and usability. KIN-nav's reliability and accuracy were analyzed in a series of 79 patients undergoing ACL reconstruction. The intra-surgeon repeatability computed for ACL-deficient and reconstructed knees at different flexion angles was less than 0.6 degrees for varus-valgus (VV) rotation, less than 1 mm for AP translation, and less than 1.6 degrees for IE rotation. The inter-surgeon repeatability is less than 2 degrees for VV rotation, 5 degrees for internal-external rotation, and less than 3 mm for AP translation. The proposed method was fast (requiring an additional 10 minutes of surgical time on average), required only a short learning period (5 cases), was minimally invasive, and was robust from the numerical perspective. Our system clearly shows that the use of navigation systems for kinematic evaluation provides useful and complete information on the knee state and test performance, and is simple and reliable to use. The good repeatability in manual kinematic tests is an improvement on the present ability to discriminate knee kinematics intra-operatively, and thus offers the possibility of better discrimination between knee pathologies and the prospect of new surgical applications.
Patient-reported outcome measures for the knee. [2022]In the past 20 years, there has been considerable growth in the number of knee instruments and rating scales designed to measure outcomes from the perspective of the patient. Only a few of these instruments have been evaluated for reliability, validity, and responsiveness. The purpose of this systematic review was to examine the psychometric evidence of patient-reported outcome measures for the knee and identify the best scores for specific knee conditions. A literature search was performed to retrieve references relating to the development and evaluation of knee-specific instruments. Twenty-four unique instruments were identified, and most have satisfactory evidence for internal (alpha > or = 0.82) and test-retest reliability (intraclass correlation coefficient > or = 0.80). Face/content validity was typically assessed during the item selection process, and construct validity was evaluated through strict hypothesis testing or correlations with other clinical measures. For many instruments, effect sizes and standardized response means measuring responsiveness were large (> or = 0.80) within disease-specific populations. Based on the psychometric data, recommendations include the Cincinnati Knee Rating System, Knee Injury and Osteoarthritis Outcome Score (KOOS), and Lysholm Knee Score for anterior cruciate ligament (ACL) injuries, the Kujala Anterior Knee Pain Scale for anterior knee pain, the International Knee Documentation Committee (IKDC) Subjective Knee Form, KOOS, and Lysholm Knee Score for focal chondral defects, the Western Ontario Meniscal Evaluation Tool (WOMET) for meniscal injuries, and the KOOS for osteoarthritis (OA). Although the IKDC can be used as a general knee measure, no instrument is currently universally applicable across the spectrum of knee disorders and patient groups. Clinicians and researchers looking to use a patient-based score for measurement of outcomes must consider the specific patient population in which it has been evaluated. Using a diagnostic algorithm that measures the anatomic parts of the knee as separate constructs may solve this dilemma, allowing for measurement of treatment outcomes across patient groups and selection of the optimal clinical intervention.
Functional knee axis based on isokinetic dynamometry data: Comparison of two methods, MRI validation, and effect on knee joint kinematics. [2013]This paper compares geometry-based knee axes of rotation (transepicondylar axis and geometric center axis) and motion-based functional knee axes of rotation (fAoR). Two algorithms are evaluated to calculate fAoRs: Gamage and Lasenby's sphere fitting algorithm (GL) and Ehrig et al.'s axis transformation algorithm (SARA). Calculations are based on 3D motion data acquired during isokinetic dynamometry. AoRs are validated with the equivalent axis based on static MR-images. We quantified the difference in orientation between two knee axes of rotation as the angle between the projection of the axes in the transversal and frontal planes, and the difference in location as the distance between the intersection points of the axes with the sagittal plane. Maximum differences between fAoRs resulting from GL and SARA were 5.7° and 15.4mm, respectively. Maximum differences between fAoRs resulting from GL or SARA and the equivalent axis were 5.4°/11.5mm and 8.6°/12.8mm, respectively. Differences between geometry-based axes and EA are larger than differences between fAoR and EA both in orientation (maximum 10.6°).and location (maximum 20.8mm). Knee joint angle trajectories and the corresponding accelerations for the different knee axes of rotation were estimated using Kalman smoothing. For the joint angles, the maximum RMS difference with the MRI-based equivalent axis, which was used as a reference, was 3°. For the knee joint accelerations, the maximum RMS difference with the equivalent axis was 20°/s(2). Functional knee axes of rotation describe knee motion better than geometry-based axes. GL performs better than SARA for calculations based on experimental dynamometry.
The KneeKG system: a review of the literature. [2022]Accurately quantifying knee joint motion is not simple. Skin movement over the medial and lateral femoral condyles is the greatest obstacle to obtaining accurate movement data non-invasively. The KneeKG™ system was developed with the objective of providing high reliability movement analysis. The goal of this manuscript is to review the technical details, clinical evidence, and potential applications of this system for evaluation of rotational knee laxity.
Knee kinetics and kinematics: What are the effects of TKA malconfigurations? [2022]Total knee arthroplasty (TKA) is a very successful surgical procedure. However, implant failures and patient dissatisfaction still persist. Sometimes surgeons are not able to understand and explain these negative performances because the patient's medical images "look good", but the patient "feels bad". Apart from radiograph imaging and clinical outcome scores, conventionally used follow-up methods are mainly based on the analysis of knee kinematics. However, even if kinematics remains close to the "normal" range of motion, the patient may still complain about pain and functional limitations. To provide more insight into this paradox, a better quantitative understanding of TKA mechanics must be developed. For this purpose, improved techniques for clinical follow-up, combining kinetics and kinematics analysis, should be introduced to help surgeons to assess and understand TKA performance.
A Novel Method to Estimate the Full Knee Joint Kinematics Using Low Cost IMU Sensors for Easy to Implement Low Cost Diagnostics. [2020]Traditional motion capture systems are the current standard in the assessment of knee joint kinematics. These systems are, however, very costly, complex to handle, and, in some conditions, fail to estimate the varus/valgus and internal/external rotation accurately due to the camera setup. This paper presents a novel and comprehensive method to infer the full relative motion of the knee joint, including the flexion/extension, varus/valgus, and internal/external rotation, using only low cost inertial measurement units (IMU) connected to the upper and lower leg. Furthermore, sensors can be placed arbitrarily and only require a short calibration, making it an easy-to-use and portable clinical analysis tool. The presented method yields both adequate results and displays the uncertainty band on those results to the user. The proposed method is based on an fixed interval smoother relying on a simple dynamic model of the legs and judicially chosen constraints to estimate the rigid body motion of the leg segments in a world reference frame. In this pilot study, benchmarking of the method on a calibrated robotic manipulator, serving as leg analogue, and comparison with camera-based techniques confirm the method's accurateness as an easy-to-implement, low-cost clinical tool.
Influence of Severity and Duration of Anterior Knee Pain on Quadriceps Function and Self-Reported Function. [2023]Little is known about how the combination of pain severity and duration affects quadriceps function and self-reported function in patients with anterior knee pain (AKP).
Diagnostic Performance of MRI for Component Loosening in Total Knee Arthroplasty Compared with Radiography. [2022]Background Because loosening of total knee arthroplasty (TKA) occurs due to poor osseous integration at component-bone interfaces, interface assessment may be helpful in diagnosing loosening at MRI. Purpose To determine interreader reproducibility for characterizing component interfaces and diagnosing loosening and to evaluate the diagnostic performance of MRI for diagnosing loosening after TKA compared with radiography. Materials and Methods Consecutive knees with TKA that underwent revision between July 2018 and June 2019 and were imaged at MRI and radiography were included in this retrospective study. Interface type (normal, fibrous membrane, fluid, or osteolysis), percent integration (<33%, 33%-66%, or >66%), and presence of bone marrow edema pattern were assessed. Loosening was diagnosed at MRI if no or almost no normal interface was present. Sensitivity and specificity were compared with radiographs by using surgical findings as reference. Gwet agreement coefficient evaluated interreader reproducibility between two readers and multivariable logistic regression assessed risk factors for loosening. Results Among 116 knees in 114 patients (mean age, 63 years ± 10 [SD]; 59 women), 61 of 116 knees (52.6%) had at least one loose component. Interreader reproducibility of MRI was substantial to excellent (Gwet agreement coefficient, 0.67-0.96). Loosening was associated with fluid interface (odds ratio [OR], 20.1; 95% CI: 5.7, 70.9) or osteolysis (OR, 3.1; 95% CI: 1.8, 5.3), absence of any normal interface (OR, 11.8; 95% CI: 6.3, 22.2), poor (<33%) osseous integration (OR, 20.4; 95% CI: 9.7, 42.6), and bone marrow edema pattern (OR, 4.7; 95% CI: 2.8, 7.8). Sensitivity and specificity of MRI for loosening were 84% (27 of 32; 95% CI: 72, 97) and 85% (71 of 84; 95% CI: 77, 92) for the patellar, 31% (eight of 26; 95% CI: 13, 49) and 100% (90 of 90; 95% CI: 100, 100) for the femoral, and 81% (22 of 27; 95% CI: 66, 96) and 98% (87 of 89; 95% CI: 95, 100) for the tibial component, respectively. MRI had higher sensitivity (84% vs 31%; P < .001) but lower specificity (85% vs 96%; P = .003) for patellar component loosening than did radiography, respectively, whereas no evidence of a difference was found for femoral (sensitivity and specificity, MRI vs radiography: 31% vs 46% [P = .20] and 100% vs 99% [P > .99], respectively) or tibial (sensitivity and specificity, MRI vs radiography: 81% vs 70% [P = .16] and 98% vs 97% [P = .32], respectively) component loosening. Conclusion MRI demonstrated substantial to excellent interreader reproducibility and higher sensitivity than did radiography for diagnosing patellar component loosening after total knee arthroplasty. © RSNA, 2022 Online supplemental material is available for this article.
Translation, cross-cultural adaptation and reliability of the International Knee Documentation Committee (IKDC) subjective knee form and the tampa scale for kinesiophobia (TSK) into Hebrew. [2023]The International Knee Documentation Committee-Subjective Form (IKDC-SF) is one of the most used measures for evaluating the quality of life among people experiencing knee pain but is not yet available in Hebrew. Similarly, the Tampa Scale for Kinesiophobia (TSK), used to evaluate fear of movement, is not available in Hebrew. This study aimed to determine the reliability and construct validity of the Hebrew IKDC-SF and TSK among people experiencing chronic knee pain.
Usefulness of the Kinect-V2 System for Determining the Global Gait Index to Assess Functional Recovery after Total Knee Arthroplasty. [2022]The Korean Knee Society (KKS) score is used for functional evaluation during follow-up after total knee arthroplasty (TKA), but it is time-consuming to measure and is limited by its subjective nature. We investigated whether the global gait asymmetry index (GGA) that can be obtained using the Kinect-V2 system could overcome the KKS limitations.