Knee Kinesiography for Anterior Knee Pain

Recruiting at 1 trial location

Overseen By Don L Goss, DPT, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Womack Army Medical Center

Disqualifiers: Pregnancy, Lower limb injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Emovi 3D Knee Assessment Device (also known as the Knee Kinesiography System) can enhance treatment for anterior knee pain through physical therapy. Participants will either receive standard care or have their therapy guided by this device, which recommends exercises based on a detailed knee assessment. The trial seeks active-duty service members at Fort Liberty and Schofield Barracks who have knee pain without other lower limb injuries or a history of knee surgery. As an unphased trial, participants can contribute to innovative research that may improve knee pain treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Emovi 3D Knee Assessment Device is safe for use in physical therapy?

Research has shown that the Emovi 3D Knee Assessment Device is easy to use and well accepted by patients. This device guides physical therapy for knee pain by providing detailed information about knee movement. It tracks knee movement in real time, allowing therapists to customize treatments to fit individual needs.

Regarding safety, no problems have been reported with using this device. As a diagnostic tool rather than a medication or surgery, it carries very low risks. The main goal is to improve therapy results by providing therapists with better information. Overall, evidence suggests it is a safe choice for managing knee pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Knee Kinesiography (KneeKG) assessment device because it offers a personalized approach to treating anterior knee pain. Unlike standard physical therapy, which follows general guidelines, the KneeKG provides detailed insights into an individual's knee biomechanics. This allows therapists to tailor exercises specifically to the patient's unique impairments, potentially leading to more effective and faster relief. By targeting the precise biomechanical issues, the KneeKG could revolutionize how we approach knee pain management, making treatments more efficient and personalized.

What evidence suggests that the Emovi 3D Knee Assessment Device is effective for anterior knee pain?

Research shows that the Emovi 3D Knee Assessment Device helps identify specific knee movement problems by providing a detailed view of knee motion and highlighting any issues. In this trial, participants in the intervention arm will receive physical therapy guided by impairments identified with the KneeKG. Studies have found that this information enables therapists to create exercises tailored to each patient's needs, focusing on the exact problems causing knee pain. Early results suggest that this method leads to better outcomes than standard physical therapy alone, potentially reducing pain and improving knee function when therapy is guided by Knee Kinesiography results. ^{1 2 5 6 7}

Who Is on the Research Team?

Don L Goss, DPT, PhD

Principal Investigator

Womack Army Medical Center

Are You a Good Fit for This Trial?

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

Active Duty Service Member stationed at Fort Liberty and Schofield Barracks

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 a current injury to my lower limb, like an ankle sprain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline measures and receive a Knee Kinesiography exam

1 day

1 visit (in-person)

Treatment

Participants receive either KneeKG informed care or usual care for 4 weeks

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Emovi 3D Knee Assessment Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention: Knee KG informed physical therapy Experimental Treatment 1 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 therapy Active Control 1 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

Who Is Running the Clinical Trial?

Womack Army Medical Center

Lead Sponsor

Trials

22

Recruited

17,100+

Medical Technology Enterprise Consortium

Collaborator

Trials

3

Recruited

340+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

Published Research Related to This Trial

Functional knee axes of rotation (fAoRs) provide a more accurate representation of knee motion compared to traditional geometry-based axes, with maximum differences in orientation and location being smaller for fAoRs than for geometry-based axes.

Among the two algorithms tested for calculating fAoRs, the Gamage and Lasenby's sphere fitting algorithm (GL) outperformed the SARA algorithm, showing better alignment with MRI-based reference axes in both orientation and location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional knee axis based on isokinetic dynamometry data: Comparison of two methods, MRI validation, and effect on knee joint kinematics. Van Campen, A., De Groote, F., Bosmans, L., et al.[2013]

MRI showed substantial to excellent interreader reproducibility for diagnosing loosening in total knee arthroplasty (TKA), with a Gwet agreement coefficient ranging from 0.67 to 0.96 among two readers.

MRI had higher sensitivity (84%) compared to radiography (31%) for detecting loosening of the patellar component, indicating it may be a more effective imaging method for this specific diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of MRI for Component Loosening in Total Knee Arthroplasty Compared with Radiography. Endo, Y., Burge, AJ., Koff, MF., et al.[2022]

A new method using low-cost inertial measurement units (IMUs) can accurately assess knee joint motion, including flexion/extension, varus/valgus, and internal/external rotation, making it a practical alternative to expensive traditional motion capture systems.

This pilot study demonstrated that the IMU-based method provides reliable results comparable to camera-based techniques, while being easier to use and requiring only a short calibration, thus enhancing accessibility for clinical analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Method to Estimate the Full Knee Joint Kinematics Using Low Cost IMU Sensors for Easy to Implement Low Cost Diagnostics. Versteyhe, M., De Vroey, H., Debrouwere, F., et al.[2020]

The KneeKG™ system offers a non-invasive and highly accurate method for quantifying knee joint motion, with an average accuracy of 0.4° for abduction/adduction and 2.3° for axial rotation, making it a reliable tool for assessing knee function.

This system is particularly useful for detecting changes in knee biomechanics related to conditions like osteoarthritis and ACL deficiency, potentially enhancing the understanding of knee injuries and their effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The KneeKG system: a review of the literature. Lustig, S., Magnussen, RA., Cheze, L., et al.[2022]

A systematic review identified 24 knee-specific patient-reported outcome measures, most of which demonstrated strong reliability and validity, making them useful for assessing knee conditions.

Recommendations for specific conditions include the Cincinnati Knee Rating System and KOOS for ACL injuries, the Kujala Scale for anterior knee pain, and the WOMET for meniscal injuries, highlighting that no single instrument is universally applicable across all knee disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures for the knee. Wang, D., Jones, MH., Khair, MM., et al.[2022]

A study involving 17 healthy male subjects demonstrated that using a standardized gesture during knee-bends significantly improves the reproducibility of 3D kinematic measurements of the knee.

The standardized knee-bends, performed in a controlled setup, showed a notable increase in the consistency of tibial rotation measurements compared to unconstrained movements, suggesting that gesture standardization is beneficial for accurate knee assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gesture standardization increases the reproducibility of 3D kinematic measurements of the knee joint. Lavoie, F., Laplante, M., Parent, G., et al.[2019]

The global gait asymmetry index (GGA), measured using the Kinect-V2 system, significantly reduces evaluation time (9.3 minutes) compared to the Korean Knee Society (KKS) score (32.4 minutes) for assessing functional recovery after total knee arthroplasty (TKA).

While the GGA index does not accurately predict KKS scores in the early postoperative phase (up to 12 weeks), it becomes a reliable and simpler alternative for evaluating functional recovery in outpatient settings after this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of the Kinect-V2 System for Determining the Global Gait Index to Assess Functional Recovery after Total Knee Arthroplasty. Cho, HM., Seon, J., Park, J., et al.[2022]

In a study analyzing four total knee arthroplasty (TKA) designs, it was found that contact forces in the knee joint can change significantly (up to 67%) due to implant malalignment, while kinematic changes were much smaller (maximum deviations of about 5 mm or 5°).

The findings suggest that traditional assessments focusing on knee kinematics may not adequately explain patient dissatisfaction or pain after TKA, highlighting the need for integrating kinetic analysis into clinical follow-up to better understand knee function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee kinetics and kinematics: What are the effects of TKA malconfigurations? Pianigiani, S., Labey, L., Pascale, W., et al.[2022]

The Hebrew versions of the IKDC-SF and TSK questionnaires have been shown to be reliable and valid tools for assessing quality of life and fear of movement in individuals with chronic knee pain, with high internal consistency (Cronbach's α of 0.85 and 0.89).

Both questionnaires demonstrated strong test-retest reliability, with Intra-Class Correlation Coefficients of 0.89 for the IKDC-SF and 0.80 for the TSK, indicating they can produce consistent results over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Yona, T., Yaniv, M., Rom, J., et al.[2023]

The functional knee analyzer developed in this study significantly reduces skin movement relative to the underlying bone, improving the accuracy of knee motion evaluation, as shown by a reduction in RMS errors by factors of 6 for displacement and 4.3 for abduction and rotation axes in four out of five healthy subjects.

This innovative device, which includes an orthoplastic exoskeleton and kinematic tracking, provides a more reliable method for assessing knee function, potentially enhancing clinical diagnosis and treatment evaluation for knee injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional knee analyzer validation by simple fluoroscopic study. Ganjikia, S., Duval, N., Yahia, L., et al.[2019]

The KIN-nav navigation system demonstrated high reliability and accuracy in assessing knee laxity during ACL reconstruction surgery, with intra-surgeon repeatability of less than 0.6 degrees for varus-valgus rotation and less than 1 mm for anterior-posterior translation across 79 patients.

This system is minimally invasive, requires only an additional 10 minutes of surgical time, and provides valuable kinematic data that can improve the differentiation of knee pathologies, potentially leading to enhanced surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description and validation of a navigation system for intra-operative evaluation of knee laxity. Martelli, S., Zaffagnini, S., Bignozzi, S., et al.[2022]

Patients with anterior knee pain (AKP) showed significantly reduced quadriceps strength and activation compared to healthy individuals, particularly in those with high severity or long duration of pain, indicating a clear impact on muscle function.

All AKP subgroups reported lower self-function scores, emphasizing the importance of considering both pain severity and duration in rehabilitation strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Severity and Duration of Anterior Knee Pain on Quadriceps Function and Self-Reported Function. Kim, S., Park, J.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06517056

Emovi 3D Knee Assessment Device Intervention for ... The purpose of this study is to assess the effectiveness of using a 3D medical assessment device versus usual care to help guide clinical decisions about ...

2. ctv.veeva.com ctv.veeva.com/study/emovi-3d-knee-assessment-device-intervention-for-operational-readiness

Emovi 3D Knee Assessment Device Intervention for ... The purpose of this study is to assess the effectiveness of using a 3D medical assessment device versus usual care to help guide clinical ...

3. emovi.ca emovi.ca/clinicians/integrate-kneekg-in-my-practice/

Integrate KneeKG System in Your Practice - Emovi The KneeKG can play an integral role in the management of pain due to orthopedic conditions, including osteoarthritis, anterior knee pain, ligament injuries ...

4. kneekinesiography.com kneekinesiography.com/

Knee Kinesiography a dynamic knee exam | KNEEKG® Knee Kinesiography is a brief clinical examination that accurately and objectively assesses the complete movement of the knee.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25002474

Knee Kinesiography for Dynamic Assessment of Anterior ... Knee kinesiography effectively detects biomechanical impairments linked to ACL ruptures, including increased internal tibial rotation and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06517056/emovi-3d-knee-assessment-device-intervention-for-operational-readiness

Emovi 3D Knee Assessment Device Intervention for ... This is a randomized clinical trial investigating the use of the Emovi Knee Kinesiography information in the treatment of anterior knee pain in

7. emovi.ca emovi.ca/knee-kinesiography/

What Is a Knee Kinesiography Exam? | EMOVI® | KNEEKG® The KneeKG is the first solution to help providers deliver diagnostic accuracy in all three planes of movement. Providing 3D alignment data.