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Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Ankle Fracture

Treatments

Procedure: Early Weight bearing + Cam Boot
Procedure: Non-Weight Bearing + Cam Boot

Study type

Interventional

Funder types

Other

Identifiers

NCT02779244
16-00720

Details and patient eligibility

About

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.

Enrollment

107 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

107 participants in 2 patient groups

Early Weight Bearing + Cam boot
Experimental group
Treatment:
Procedure: Early Weight bearing + Cam Boot
Standard Treatment Cam boot
Active Comparator group
Treatment:
Procedure: Non-Weight Bearing + Cam Boot

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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