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

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.

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 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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

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. ^{1 7 10 11 12}

Research Team

Don L Goss, DPT, PhD

Principal Investigator

Womack Army Medical Center

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

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 had knee surgery in the past.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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]

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]

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]

References

1. United States 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. [2013]

2. Germany pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures for the knee. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Gesture standardization increases the reproducibility of 3D kinematic measurements of the knee joint. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Influence of Severity and Duration of Anterior Knee Pain on Quadriceps Function and Self-Reported Function. [2023]

5. Germany 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. [2023]

6. Australia 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

The KneeKG system: a review of the literature. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of MRI for Component Loosening in Total Knee Arthroplasty Compared with Radiography. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Knee kinetics and kinematics: What are the effects of TKA malconfigurations? [2022]

10. England pubmed.ncbi.nlm.nih.gov

Description and validation of a navigation system for intra-operative evaluation of knee laxity. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Three-dimensional knee analyzer validation by simple fluoroscopic study. [2019]

12. Switzerland 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. [2020]