NCT06193343 Steps Towards Osteoarthritis Prevention
| NCT ID | NCT06193343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Georgia |
| Condition | Anterior Cruciate Ligament Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2024-09-23 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2024-09-23 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Optimal knee joint loading, which refers to the forces acting on the knee caused by daily activities such as daily steps, plays an essential role in maintaining knee articular cartilage health and reducing the risk of osteoarthritis (OA). After anterior cruciate ligament reconstruction (ACLR), individuals take fewer daily steps as compared to uninjured controls resulting in insufficient knee joint loading to joint tissues, but it is unclear how changes in daily steps impact knee joint cartilage health in OA development. Therefore, the overall single arm, longitudinal pre-test post-test study objective is to determine the mechanistic links between knee joint loading as measured by daily steps and comprehensive magnetic resonance imaging (MRI) measures of knee joint cartilage health post-ACLR. The central hypothesis is that individuals post-ACLR who take low daily steps will demonstrate deconditioned, less resilient cartilage characterized by poor tibiofemoral cartilage composition and greater cartilage strain.
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * For children, signed and dated informed assent by child and parental permission form by parent/guardian to participate in the study * Underwent an anterior cruciate ligament reconstruction (ACLR) between 6-60 months prior to enrollment * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Completed all other formal physical therapy and therapeutic exercise regimens, and will not be engaging in any other formal therapy for their ACLR during the study * Physician clearance for unrestricted activity * Owning a smartphone * Demonstrate \< 8,000 steps per day during the screening phase of aim 2 as assessed using the Actigraph Link monitor Exclusion Criteria: * Underwent an ACLR revision surgery due to a previous anterior cruciate ligament (ACL) graft injury * A multiple ligament surgery was indicated with their ACL injury * A lower extremity fracture was suffered during the ACL injury * The participant has previously been diagnosed with any diseases that affect joints is present in either knee including knee osteoarthritis inflammatory arthritis * Pregnant or plans to become pregnant over next 4 months * Body mass index (BMI) ≥ 36 kg/m2 * Unable to speak English * Cochlear implant * Metal in body (metal fragments, shrapnel, permanent make-up, body piercings that cannot be removed) * Claustrophobia * History of seizures * Pacemaker
Contact & Investigator
Caroline Lisee, PhD
PRINCIPAL INVESTIGATOR
University of Georgia
Frequently Asked Questions
Who can join the NCT06193343 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 40 Years, studying Anterior Cruciate Ligament Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06193343 currently recruiting?
Yes, NCT06193343 is actively recruiting participants. Contact the research team at caroline.lisee@uga.edu for enrollment information.
Where is the NCT06193343 trial being conducted?
This trial is being conducted at Athens, United States.
Who is sponsoring the NCT06193343 clinical trial?
NCT06193343 is sponsored by University of Georgia. The principal investigator is Caroline Lisee, PhD at University of Georgia. The trial plans to enroll 56 participants.