A new physical therapy twist could rebuild knees after dislocation

NCT ID NCT04554212

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests whether a specialized physical therapy technique called blood flow restriction training (BFRT) can improve recovery in people who have experienced a patellar dislocation (kneecap slipping out of place). Participants will undergo 8 weeks of either BFRT or a sham version, where a cuff is inflated to different pressures. The study measures knee stability, quadriceps strength, and cartilage health to see if BFRT offers benefits over standard rehabilitation.

What this could mean

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

Active substance
Blood flow restriction training (BFRT) using a cuff inflated to 60% occlusion, compared to a sham cuff at less than 10% occlusion
What this could lead to
If effective, BFRT could become a standard part of physical therapy to help people with patellar instability regain strength and stability faster.
What could go wrong
This is a relatively small trial, and the results may not apply to everyone. The training is intense and may not be suitable for all patients, with potential risks like muscle soreness or discomfort.

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 78 people

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

Started

Sep 2020

Expected to finish

Jun 2027

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

14 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: * Diagnosis of traumatic patellar instability (either primary or recurrent) determined by an American Board of Family Medicine certified physician with a Certificate of Added Qualifications in Sports Medicine or licensed Physical Therapist utilizing clinical examination, radiographic imaging, and patients' reports of instability * Age 14 to 40 years * Skeletally mature with closed growth plates visualized by radiograph * A score of 80 or more on the Sports Activity Scale, which corresponds to participating in "running, twisting, turning (tennis, racquetball, handball, ice hockey, field hockey, skiing, wrestling)" at least 1-3 times per week * Desire to resume pre-injury activity level Exclusion Criteria: * Concomitant osteochondral lesion requiring surgical fixation * Radiographic evidence of osteoarthritis (\< Kellgren-Lawrence Grade 2) * Previous ipsilateral or contralateral knee surgery * Most recent instability event more than 3 months before enrollment * History of any inflammatory disorder * BMI \> 35 kg/m2 * Diabetes or uncontrolled hypertension * Varicose veins or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis * Pre-existing conditions or previous surgeries that effect the ability to walk * Planned trips or vacations that will result in the inability to attend 4 consecutive physical therapy sessions

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Conditions

The condition(s) this trial relates to.

injury Knee Injuries Leg Injuries Patellar Dislocation

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    4 sites. 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

  • Center for Sports Performance and Research

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • Foxboro Sports Medicine Clinic

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • UK Healthcare at Turfland

    RECRUITING

    Lexington, Kentucky, 40504, United States

  • University of Kentucky Biomotion Laboratory

    RECRUITING

    Lexington, Kentucky, 40536, United States

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