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Ankle surgery study pulled before it started: was routine arthroscopy a waste?

NCT ID NCT02470338

Knowledge-focused Sponsor: Edna Rath 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if adding a routine ankle arthroscopy to the Modified Broström Procedure for lateral ankle instability is necessary. The researchers believed the extra procedure may be wasteful, increase costs, and expose patients to more risks. However, the trial was withdrawn before enrolling any participants, so no data were collected.

What this could mean

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

Active substance
Modified Broström Procedure with or without diagnostic ankle arthroscopy
What this could lead to
If successful, this could show that routine ankle arthroscopy is not needed for lateral ankle instability surgery, saving time and reducing risks.
What could go wrong
The trial was withdrawn before enrolling any participants, so no results are available. The findings would have been limited to a specific surgical population.

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.

Start date

Jun 2015

Expected to finish

Jun 2018

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Able to independently consent for surgery 2. Able to demonstrate an understanding of study procedures 3. Adult patient 18 years of age or older 4. All active duty soldiers, Veterans, dependents 5. Ability to comply with study procedures for the entire length of the study 6. Presence of lateral ankle instability meeting operative criteria listed in 6.2.1 with documented failed conservative measures such as: physical therapy, ankle braces, and rest Exclusion Criteria: 1. Unable to obtain medical clearance for surgery 2. Recent (1 month) febrile illness that precludes or delays participation 3. History of or suspected of drug/alcohol abuse, as these patients may not be compliant with physical therapy. All patients are required to be immobilized for 6 weeks after surgery 4. Pregnant women, this is an elective procedure and a MBP or ankle arthroscopy is not typically offered to pregnant women. Screening for pregnancy is done as part of standard of care

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As listed by the trial registrant

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

Lateral ankle instability

Contacts and locations

Locations

  • William Beaumont Army Medical Center

    El Paso, Texas, 79920-5001, United States

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