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Can a cuff that restricts blood flow speed up ACL recovery?

NCT ID NCT05735236

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study investigates whether using a blood flow restriction (BFR) cuff during physical therapy helps people recover strength and function faster after ACL knee reconstruction surgery. Participants are randomly assigned to either standard physical therapy alone or standard therapy plus a BFR cuff on the surgical leg. Over two years, researchers measure knee strength and patient-reported outcomes to see if BFR therapy offers any advantage.

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 (BFR) Cuff
What this could lead to
If effective, BFR therapy could help people regain knee strength faster after ACL surgery, potentially shortening recovery time.
What could go wrong
This is a small, early-stage study (78 people) comparing BFR to standard care. Results may not apply to everyone, and BFR cuffs carry risks like discomfort or rare blood clots.

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

Nov 2022

Expected to finish

Nov 2026

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 60 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: * Patients undergoing primary knee arthroscopy for ACL reconstruction without meniscus repair * Completing initial 12 weeks of physical therapy at the Steadman Hawkins Clinic in Denver * Patients with access to smartphone device Exclusion Criteria: * Bilateral knee surgeries to be performed within 12 weeks of each other * Patients received meniscus repairs, chondral lesion repair/transplants, * Prior surgery on the same knee * Anyone who meets the following contraindications for BFR therapy: * Deep Vein Thrombosis (DVT) * Pulmonary Embolism * Hemorrhagic/Thrombolytic Stroke * Clotting Disorders * Hemophilia or taking blood thinners * Pregnant or up to 6 months post-partum * Untreated Hypertension * Untreated Hypotension * Rhabdomyolysis or recent traumatic injury 2\. Exclusion criteria will be evaluated via the medical record as well as by the expert opinion of the physician. 3\. If at any point in the study a subject develops one of the above contraindications, they will be removed from the study. 4\. If a subject becomes pregnant while participating in the intervention portion of the study, they will be removed.

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries

As listed by the trial registrant

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

Acl tear

Contacts and locations

Locations

  • UCHealth Steadman Hawkins Clinic

    Centennial, Colorado, 80111, United States

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