Dynamic ACL Brace: In Vivo Kinematics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of the Össur Rebound dynamic ACL brace on knee kinematics evaluated using dynamic stereo X-ray (DSX) imaging during functional activities. Brace performance will be evaluated before and after ACL reconstruction.

Official Title
-----------------
Dynamic ACL Brace: In Vivo Kinematics

Conditions
-----------------
ACL, ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL - Anterior Cruciate Ligament Deficiency

Intervention / Treatment
-----------------
* Device: Ossur Rebound ACL Brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral, complete ACL (Anterior Cruciate Ligament) ruptures (must be documented by prior MRI) No other concomitant lower extremity injuries and an uninjured contralateral limb Acute ACL tears that will be scheduled for ACL reconstruction with Dr. Robert F. LaPrade Minimal swelling and pain Able and willing to perform the required study activities Exclusion Criteria: Previous surgery or significant injury to either knee Relevant surgery, procedure, injury, or condition in the past two years which may affect knee pain or general movement patterns on either side Diagnosis of osteoarthritis, rheumatoid conditions, cancers, or other conditions which may affect musculoskeletal health Women who are pregnant, or trying/planning to become pregnant during the next 10 months Known balance or vestibular disorders Persons with a history of significant radiation exposure, whether occupational or medical in nature (Anyone with a history of medical radiation therapy, for cancer or other conditions, is excluded from the study. Those who have an annual occupational radiation exposure greater than 25mSv may not enroll.) Persons with a pacemaker, hearing aid, aneurysm clip or artificial heart valve, or other forms of loose metal implants Initial MRI exclusion criteria (assessed by clinical MRI obtained as standard of care at time of ACL injury diagnosis): concomitant injury, multi-ligamentous injury, significant meniscal damage Allergy or sensitivity to silver or latex Adults lacking capacity to consent for themselves Post-Op Visit Exclusion Criteria Participants who do not pass their return-to-sport test within 7-9 months of ACL-Reconstruction surgery will be excluded from the second phase of testing. Participants who no longer pass the MRI screening at the time of Phase 2 testing (for example, who have a new loose metal implant), will be excluded from the MRI portion of the testing only.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Evaluation of knee stability with brace wear. Control is same subject without the brace.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee Brace<br>ACL-reconstruction patients will be issued an Ossur Rebound ACL Brace at the time of enrollment in the study, prior to surgery. They will use this brace throughout their rehab and physical therapy. Dynamic X-ray imaging of the knee will take place prior to surgery, and again upon clearance from physical therapy 7-9 months after surgery. The injured knee will be imaged with and without the brace, and the contralateral limb will be imaged for use as a control. | Device: Ossur Rebound ACL Brace<br>* ACL-reconstruction patients will be issued an Ossur Rebound ACL Brace at the time of enrollment in the study, prior to surgery. They will use this brace throughout their rehab and physical therapy. The intervention (brace) will be applied only to the surgical limb.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic tibiofemoral kinematics during activities of daily living in ACL-deficient knees | This study will use dynamic stereo x-ray (pulsed bi-plane fluoroscopy) to measure the dynamic movements of the tibiofemoral joint during walking and stair-climbing, focusing on differences in anterior-posterior sliding and internal/external rotation of the tibia relative to femur, between the braced ACL-deficient knee, unbraced ACL-deficient knee, and the contralateral/uninjured knee. | <1wk (pre-operative) | 
| Dynamic tibiofemoral kinematics during sports activities in ACL-reconstructed-knees | This study will use dynamic stereo x-ray (pulsed bi-plane fluoroscopy) to measure the dynamic movements of the tibiofemoral joint during dynamic movements and sports activities, focusing on differences in anterior-posterior sliding and internal/external rotation of the tibia relative to femur, between the braced ACL-reconstructed knee, unbraced ACL-reconstructed knee, and contralateral/uninjured knee. | 7-9 months (post-operative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent symmetry in 3D motion capture kinematics and kinetics | Whole-body kinematics and ground reaction forces will be calculated to assess joint angle and ground reaction force symmetry between braced and unbraced conditions during activities of daily living (<1wk) and dynamic/sports activities(7-9months post-operatively). | <1wk; 7-9months | 
| Muscle contribution levels in braced vs unbraced knee | Electromyography sensors will detect differences in muscle contributions (in major muscles of the lower extremity) between the braced ipsilateral leg, unbraced ipsilateral leg, and contralateral leg during activities of daily living and dynamic sports activities. | <1wk; 7-9 months | 
| Subject Satisfaction | An overall satisfaction score for brace comfort will be obtained from the 'Quebec User Evaluation of Satisfaction with Assistive Technology.' | 2 months; 4 months; 7-9 months |