Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT03670550
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03670550
Study Brief:
Protocol Section:
NCT03670550