Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02779244

Enrollment

107

Registered

2016-05-20

Start date

2017-09-01

Completion date

2023-07-01

Last updated

2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fracture

Keywords

Orthopedic, Post-operative, Weight bearing, Range of motion

Brief summary

The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery. Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.

Interventions

PROCEDUREEarly Weight bearing + Cam Boot

Patients will be transitioned to weight bearing as tolerated in a cam boot.

PROCEDURENon-Weight Bearing + Cam Boot

Subject will be transitioned to non weight bearing cam boot, standard treatment.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Operative unstable ankle fractures

Exclusion criteria

* Requirement of syndesmotic fixation * Pilon fractures * Open fractures * Patients with diabetic neuropathy * BMI\>40 * Polytrauma patients * Patients who are unable to comply with non-weight bearing * Patients who are unable to follow up

Design outcomes

Primary

Measure	Time frame	Description
Olerud Molander Ankle Score	1 year	The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026