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Can a steroid shot before surgery tame leg swelling?

NCT ID NCT03915223

Symptom relief Sponsor: University Hospital, Clermont-Ferrand 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether giving a steroid injection just before surgery for a broken leg can reduce swelling and pain compared to a placebo. Adults with certain leg fractures who need surgery within 72 hours are randomly assigned to receive either the steroid or a saline injection. The main goal is to see if the steroid helps decrease leg swelling after the operation.

What this could mean

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

Active substance
Solumedrol (a steroidal anti-inflammatory drug) injected before surgery
What this could lead to
If effective, this could offer a simple way to reduce swelling and pain after leg fracture surgery, potentially speeding recovery.
What could go wrong
The trial is relatively small and early, and the benefits may not be clear or could come with risks like infection or delayed healing.

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

104 people

The number who actually took part.

Started

May 2019

Finished

May 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

18 years and older

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: * Patient over the age of 18, hospitalized in the Orthopedics Department for a leg fracture (ankle, tibia: proximal, diaphysis, distal) requiring surgery within 72 hours of the trauma * Patient covered by the social security system * Patient giving informed consent Exclusion Criteria: * Open fracture with infectious risks cauchoix 2 and 3 * Multiple trauma, * Pathological fracture on primary or secondary lesions, * Pre-existing bone disease (excluding osteoporosis) of the operated limb, * Diabetes, * Pre-existing trophic disorders on one of the 2 lower limbs, * Long-term corticotherapy, * Pathology of the pituitary-adrenal axis, * Any other contraindication to glucocorticoids: any infectious condition, some developing viral diseases (including hepatitis, herpes, chicken pox, shingles), hypersensitivity to one of the constituents * Hypernatremia and hypochloremia * Pre-existing severe cardiac injury * Contraindication to TegadermTM * Patient placed under guardianship, tutorship or safeguard of justice, * Pregnant or lactating women,

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Conditions

The condition(s) this trial relates to.

bone fracture Edema Leg Injuries

As listed by the trial registrant

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

Edema Fracture Leg injuries

Contacts and locations

Locations

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000, France

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