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Can a surgical device prevent stiff knee after ACL surgery?

NCT ID NCT04998656

Prevention 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers compare the Werewolf FLOW 50 electrocautery device with standard care during ACL reconstruction in patients aged 12 to 18. The trial measures how many participants develop arthrofibrosis, a complication that restricts knee movement, and tracks knee range of motion and patient-reported outcomes. The goal is to see whether using the device reduces post-operative knee stiffness compared with surgery that does not use electrocautery.

What this could mean

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

Active substance
Werewolf FLOW 50 electrocautery device
What this could lead to
If the device lowers knee stiffness after ACL surgery, it could become a routine tool in teen ACL reconstruction and reduce the need for follow-up procedures.
What could go wrong
This is a single-center study in teens, so results may not apply to adults or other hospitals. Electrocautery can damage tissue if used incorrectly, and the device may not outperform standard care.

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

182 people

The number who actually took part.

Started

Jul 2021

Finished

Nov 2024

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

12 to 18 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: * Ages 12-18 (inclusive) at time of surgery * Scheduled to undergo ACL reconstruction performed at Children's Hospital Colorado or associated network of care site. Exclusion Criteria: * Underlying congenital or musculoskeletal disorders * Pregnant females, prisoners, and wards of the state * Persons deemed incompetent and those who have limited decision-making capacity

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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.

Anterior cruciate ligament injuries Anterior cruciate ligament rupture Anterior cruciate ligament tear Arthrofibrosis of knee

Contacts and locations

Locations

  • Children's Hospital Colorado, Main Campus

    Aurora, Colorado, 80045, United States

  • Children's Hospital Colorado, North Campus

    Broomfield, Colorado, 80023, United States

  • Children's Hospital Colorado, South Campus

    Highlands Ranch, Colorado, 80129, United States

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