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Prevention study for Anterior Cruciate Ligament Injuries
Official title Steps Towards Osteoarthritis Prevention
ClinicalTrials.gov ID: NCT06193343
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 40
You may be able to join if
- 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...
You likely can't join if
- 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...
- Pregnant or plans to become pregnant over next 4 months
- Body mass index (BMI) ≥ 36 kg/m2
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.