KneeStim for ACL Injury

Overseen By Madison Mach, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Keller Army Community Hospital

Disqualifiers: Pacemaker, Epilepsy, Pregnancy, Dementia, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are: * Examine the effects of KneeStim wear on cadets' post-operative gait * Examine changes in site-specific skeletal muscle mass * Examine the changes in patient-reported outcomes * Assess time to return to full duty * Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume) * Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture) Participants will undergo body composition analysis, MRI, strength testing, standard of care rehabilitation, gait analysis, and complete surveys. Participants will wear the KneeStim during their standard of care rehabilitation visits for the first 5 weeks post-operative, and throughout daily tasks from 6-12 weeks. Researchers will compare a control group (standard of care + KneeStim controlled low intensity) to an experimental group (standard of care + KneeStim flexible intensity) to assess the aims previously mentioned..

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the KneeStim treatment for ACL injury different from other treatments?

The KneeStim treatment for ACL injury is unique because it may involve a personalized approach that considers individual anatomical differences in the knee's extensor mechanism, potentially improving outcomes by tailoring rehabilitation to each patient's specific needs. ^{1 2 3 4 5}

Research Team

Shawn M Gee, MD

Principal Investigator

Keller Army Community Hospital

Eligibility Criteria

This trial is for US Military Academy cadets aged 17-27 who've had ACL reconstruction. They'll test a knee sleeve device (KneeStim) during recovery to see if it improves walking, muscle mass, and speeds up return to duty. Cadets must be able to undergo MRI and strength tests.

Inclusion Criteria

I am a 17-27 year old US Military Academy cadet getting ACL surgery.

Exclusion Criteria

I have had a procedure to repair cartilage.

I have had a high tibial osteotomy surgery.

I am having or have had surgery to repair one or more knee ligaments.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the KneeStim device during standard rehabilitation visits and daily tasks to improve post-operative gait and muscle function

12 weeks

Weekly visits for rehabilitation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of gait, muscle mass, and knee function

12 months

Monthly assessments

Treatment Details

Interventions

• KneeStim (Electrical Stimulation)

Trial Overview The study compares the effects of KneeStim at low vs. flexible intensities on post-surgery gait, muscle growth, patient-reported outcomes, and time to full duty. It includes body analysis, MRI, strength testing, gait analysis with a control group for comparison.

Participant Groups

Group I: Standard of Care + KneeStim flexible intensity Experimental Treatment 1 Intervention

Flexible to high intensity range

Group II: Standard of Care + KneeStim controlled low intensity Placebo Group 1 Intervention

Low intensity range

Who Is Running the Clinical Trial?

Keller Army Community Hospital

Lead Sponsor

Trials

16

Recruited

2,100+

Medical Technology Enterprise Consortium

Collaborator

Trials

3

Recruited

340+

Findings from Research

In individuals with ACL injuries, a significant negative correlation was found between the patellar ligament insertion angle (PLIA) and peak knee flexion moment during walking, suggesting that anatomical variations influence quadriceps usage to prevent excessive anterior tibial translation (ATT).

The study indicates that individuals with larger PLIA tend to reduce their peak knee flexion moment more significantly after ACL injury, which may help avoid further knee damage and suggests that personalized rehabilitation strategies based on individual anatomical differences could enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patella ligament insertion angle influences quadriceps usage during walking of anterior cruciate ligament deficient patients. Shin, CS., Chaudhari, AM., Dyrby, CO., et al.[2016]

In ACL-deficient knees, there is a significant increase in the posterior translation of the medial femoral condyle compared to healthy knees, indicating altered knee mechanics that could lead to further injury.

Despite the changes in femoral translation, the menisco-tibial translation remains relatively unchanged, suggesting that the medial meniscus may be at risk for shear forces, which could explain the high incidence of secondary meniscal tears in ACL-deficient patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Femoro-tibial and menisco-tibial translation patterns in patients with unilateral anterior cruciate ligament deficiency--a potential cause of secondary meniscal tears. von Eisenhart-Rothe, R., Bringmann, C., Siebert, M., et al.[2016]

The study evaluated a new digital arthrometer for measuring anterior tibial translation (ATT) in 60 participants, including 30 with ACL injuries and 30 healthy controls, showing high reliability (interrater ICC of 0.909 and intrarater ICC of 0.943).

Significant differences in knee laxity were found between ACL injury patients and healthy subjects, with the digital arthrometer demonstrating good diagnostic accuracy (AUC of 0.857) at a load of 150 N, indicating its potential as an effective tool for clinical assessment of knee injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel digital arthrometer to measure anterior tibial translation. Wu, D., Wang, D., Han, Y., et al.[2023]

In a study involving 10 patients with unilateral ACL insufficiency, the ACL-insufficient knees showed significantly greater anterior-posterior translation of the medial femoral epicondyle (11.5 mm) compared to the healthy contralateral knees (7.7 mm), indicating altered knee mechanics during the Lachman test.

The study also found that during the Lachman test, the distal femur rotated externally more than the proximal tibia, highlighting differences in knee joint motion between ACL-insufficient and healthy knees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic Three-Dimensional Analysis of Lachman Test for Anterior Cruciate Ligament Insufficiency: Analysis of Anteroposterior Motion of the Medial and Lateral Femoral Epicondyles. Koo, S., Kyung, BS., Jeong, JS., et al.[2020]

The KT-1000 knee arthrometer is a tool designed to objectively measure the movement of the tibia in relation to the femur for assessing anterior cruciate ligament (ACL) injuries, but its validity as a diagnostic tool is limited based on the reviewed studies.

It is recommended to use the KT-1000 cautiously and to consider a scoring method that compares the injured knee's motion to the uninjured knee, using a threshold of 2 or 3 mm for better diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review article: Validity of the KT-1000 knee ligament arthrometer. Arneja, S., Leith, J.[2017]

References

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

The patella ligament insertion angle influences quadriceps usage during walking of anterior cruciate ligament deficient patients. [2016]

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

Femoro-tibial and menisco-tibial translation patterns in patients with unilateral anterior cruciate ligament deficiency--a potential cause of secondary meniscal tears. [2016]

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

A novel digital arthrometer to measure anterior tibial translation. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Dynamic Three-Dimensional Analysis of Lachman Test for Anterior Cruciate Ligament Insufficiency: Analysis of Anteroposterior Motion of the Medial and Lateral Femoral Epicondyles. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Review article: Validity of the KT-1000 knee ligament arthrometer. [2017]