KneeStim for ACL Injury

Overseen By Madison Mach, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Keller Army Community Hospital

Disqualifiers: Pacemaker, Epilepsy, Pregnancy, Dementia, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device, KneeStim, to determine its effectiveness in aiding recovery after ACL surgery. The researchers aim to discover if the device improves walking, muscle strength, and the speed of returning to normal activities. Participants will be divided into two groups: one using a low-intensity setting and the other using a flexible-intensity setting, to compare effects. This trial suits cadets at the United States Military Academy who have undergone ACL reconstruction surgery. As an unphased trial, participants can contribute to innovative research that may enhance recovery methods for future patients.

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.

What prior data suggests that the KneeStim device is safe for post-operative use?

Research has shown that devices like the KneeStim, which use electrical stimulation to aid muscles, can be safe and well-tolerated after knee surgery. Studies have found that this treatment can strengthen muscles, particularly the quadriceps (the large muscle at the front of the thigh), when combined with exercise during recovery from ACL (anterior cruciate ligament) surgery.

These treatments are generally safe, with few reports of major side effects. Most patients experience only mild side effects, such as skin irritation where the device contacts the skin. The KneeStim resembles these devices, suggesting it might have a similar safety profile. Since this trial does not specify its phase and the KneeStim isn't approved for other uses, the safety information is based on these similar devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about KneeStim for ACL injury because it offers a new approach to rehabilitation using electrical stimulation. Unlike traditional treatments like physical therapy and surgical repair, KneeStim uses a flexible intensity range of electrical impulses to possibly enhance healing and strength recovery. This method could offer a more targeted way to stimulate muscle and tissue repair, potentially speeding up recovery time and improving outcomes for patients. Additionally, the option of controlled low-intensity stimulation in the sham comparator group allows researchers to evaluate the optimal intensity needed for effective treatment.

What evidence suggests that the KneeStim device is effective for improving post-operative gait in ACL injury?

Research has shown that using a device called KneeStim, which provides electrical stimulation, along with exercise soon after ACL surgery, can help strengthen the thigh muscles. In this trial, participants will receive either a flexible intensity or controlled low intensity version of KneeStim alongside standard care. Early studies suggest that this electrical stimulation aids in muscle recovery and stability after an ACL injury. This may lead to better walking patterns and increased muscle mass in the thigh. The aim is to support a faster and more effective recovery. ^{3 6 7 8 9}

Who Is on the Research Team?

Shawn M Gee, MD

Principal Investigator

Keller Army Community Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• KneeStim

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2744659/

Knee stability assessment on anterior cruciate ligament injury This article firstly introduces a management model for ACL injury and the contribution of knee stability assessment to the corresponding stages of the model.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8255602/

Artificial Intelligence in the Management of Anterior ... Description of the commonly used artificial intelligence models in the management of anterior cruciate ligament (ACL) injury. Because of the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02699411

Dry Needling Effectiveness of Patients on Break Anterior ... We will conduct a randomized clinical trial observing forty patients divided into two groups: one group composed of twenty individuals undergoing surgery ...

4. jospt.org jospt.org/doi/10.2519/jospt.2010.3184

Effects of Neuromuscular Electrical Stimulation After ... The present review supports the use of NMES in conjunction with exercise during the first 4 weeks following ACL reconstruction to improve quadriceps strength.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268003314003015

Anterior cruciate ligament biomechanics during robotic and ... Approximately 65% of ACL ruptures occur in noncontact situations, which indicate that the injuries are likely influenced by poor neuromuscular control and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06341868

Dynamic Muscular Electrical Stimulation Following Anterior ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6405414/

Validation of Non-Contact Anterior Cruciate Ligament ... The mechanical impact simulator induced ACL injuries in 87% of specimens with medial collateral ligament (MCL) injuries in 31%. ACL tear locations were 71% ...

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

Knee Kinesiography for Dynamic Assessment of Anterior ... Anterior cruciate ligament (ACL) ruptures are common, particularly among athletes, and lead to altered biomechanics that complicate ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/smm2.1271

Knee function assessment of anterior cruciate ligament ... The test results show that our sensor can dynamically assess knee function in real time and recommend the best timing for return to play, which ...