Promoting daily steps to prevent osteoarthritis after ACL reconstruction
Steps Towards Osteoarthritis Prevention: A Pilot Study
This study is testing if increasing daily steps can help protect knee cartilage and prevent osteoarthritis in people who have had ACL surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | All |
| Sponsor | University of Georgia Academic / other |
| Locations | 1 site (Athens, Georgia) |
| Trial ID | NCT06193343 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between daily step counts and knee joint cartilage health in individuals who have undergone anterior cruciate ligament reconstruction (ACLR). It aims to determine how low daily step frequency affects cartilage composition and resilience, potentially contributing to the development of osteoarthritis. Participants will be monitored for their daily steps using an Actigraph Link monitor, and comprehensive MRI assessments will be conducted to evaluate knee joint health. The study seeks to identify modifiable factors that could help prevent osteoarthritis in this at-risk population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and older who have undergone ACL reconstruction within the last 6 to 24 months and demonstrate low daily step counts.
Not a fit: Patients who have had revision ACL surgery or multiple ligament surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective strategies for preventing osteoarthritis in individuals recovering from ACL reconstruction.
How similar studies have performed: While studies have focused on excessive joint loading in osteoarthritis, this approach of examining low loading frequency is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Athens, Georgia
- University of Georgia — Athens, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Caroline Lisee, PhD — University of Georgia
- Study coordinator: Caroline Lisee, PhD
- Email: caroline.lisee@uga.edu
- Phone: 706-542-7137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.