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Walking sooner after ankle surgery: does it help?

NCT ID NCT04028414

Knowledge-focused Sponsor: Major Extremity Trauma Research Consortium 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether starting to put weight on your leg early after ankle fracture surgery helps you recover better than waiting longer. 435 adults who had surgery for certain types of ankle fractures took part. Researchers tracked complications and how quickly people returned to their usual activities and work.

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

435 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 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: 1. Adults ages 18 or older 2. Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria: 1. bimalleolar fracture requiring fixation of any two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior) 2. bimalleolar equivalent SER4 fractures (lateral malleolus fracture requiring fixation and no medial or posterior malleolus fixation) 3. trimalleolar fracture with fixation of at least two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior) 3. Operative treatment of an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction. Exclusion Criteria: 1. Gustilo Type III injuries or soft tissue injury of either lower extremity that would contra-indicate immediate or delayed WB 2. Syndesmotic injuries/fixation 3. Osteoporosis as defined by treatment with a bisphosphonate and/or other osteoporosis medications, including Prolia and Forteo; or a prior fragility fracture (e.g., spine compression, proximal humerus, distal radius, femoral neck/intertrochanteric fracture) 4. Neuropathy, defined as diagnosis of peripheral neuropathy in medical record, neuropathic foot ulcer, or diminished or absent plantar sensation to light touch. 5. Pathologic fracture related to neoplasm 6. Fractures and dislocations to the ipsilateral or contralateral lower limb that prevent weight bearing as tolerated after fist post-op visit 7. Other contra-indication to immediate or delayed weight bearing (e.g., ipsilateral fracture effecting weight bearing status such as a calcaneus fracture); fractures of the ipsilateral lower extremity that would not affect WB status may be included (e.g., proximal femur, femoral shaft or tibia shaft fractures) 8. Any upper limb injury that would limit upper extremity weight bearing (e.g., surgical neck fracture of proximal humerus) 9. Injuries to other body systems that would affect the ability to comply with either WB protocol (e.g., spinal cord injury; severe TBI; major abdominal or chest injury) 10. Patient has third degree burns on \>10% total surface area affecting the study limb 11. Tibial plateau fractures that are required to wear a locking brace or fractures that require fixed immobilization beyond four weeks (e.g., cast) 12. Non-ambulatory pre-injury 13. Pre-injury limitation to ROM of ipsilateral hip, knee or ankle 14. Morbidly obese (BMI ≥40) 15. Documented psychiatric disorder requiring admission in perioperative period 16. Severe problems with maintaining follow-up (e.g., patients who are prisoners or homeless at the time of injury or who are intellectually challenged without adequate family support)

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Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

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

Rehabilitation

Contacts and locations

Locations

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Hennepin County Medical Center / Regions Hospita

    Minneapolis, Minnesota, 55415, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Methodist Hospital

    Indianapolis, Indiana, 46202, United States

  • San Antonio Military Medical Center (SAMMC)

    San Antonio, Texas, 78234, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California San Francisco Medical Center

    San Francisco, California, 94143, United States

  • University of Maryland R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • University of Washington/Harborview Medical Center

    Seattle, Washington, 98104, United States

  • University of Wisconsin

    Madison, Wisconsin, 53705, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.