Dynamic ACL Brace: In Vivo Kinematics

Steadman Philippon Research Institute

Status: Withdrawn

Conditions: ACL; ACL - Anterior Cruciate Ligament Deficiency; ACL - Anterior Cruciate Ligament Rupture; ACL Injury

Treatments: Device: Ossur Rebound ACL Brace

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03670550

2018-31

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Knee Brace

Experimental group

Description:

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.

Treatment:

Device: Ossur Rebound ACL Brace