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Step count may hold key to preventing osteoarthritis after ACL injury

NCT ID NCT06193343

Knowledge-focused Sponsor: University of Georgia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study is testing whether increasing daily steps can improve knee cartilage health in people who have had ACL reconstruction. Fifty-six participants will wear a Fitbit and receive daily step goals via text for 16 weeks. Researchers will use MRI scans to measure changes in cartilage composition and strain, aiming to understand how walking affects osteoarthritis risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Adaptive Daily Step Promotion (behavioral intervention using Fitbit and text messages)
What this could lead to
If successful, this study could show that increasing daily steps after ACL reconstruction improves knee cartilage health, pointing toward a simple way to prevent osteoarthritis.
What could go wrong
This is a small pilot study with only 56 participants and no control group, so results may not be generalizable. It measures early markers, not actual osteoarthritis prevention.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries osteoarthritis, knee prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anterior cruciate ligament injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Georgia

    RECRUITING

    Athens, Georgia, 30602, United States

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