RecruitingNot ApplicableNCT03966027

Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures


Sponsor

Kyle Schweser MD

Enrollment

25 participants

Start Date

Aug 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Adults 18 and ove
  • Positive for diabetes
  • Positive monofilament test
  • Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture
  • Weight less than 275 (124kg)
  • Can tolerate and comply with brace
  • No signs of pre-existing charcot arthroplasty or ankle deformity

Exclusion Criteria7

  • Children
  • Pregnant patients
  • No signs of diabetes complicated by neuropathy
  • Non-operative ankle fractures
  • Multiple extremity injury
  • Cannot follow post-operative protocol
  • Chronic ankle fractures receiving surgery beyond 3 weeks of injury

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Interventions

OTHERPostoperative protocol (Immediate weight bearing)

After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace

OTHERPostoperative Protocol (Delayed Weight Bearing)

After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol


Locations(1)

University of Missouri Health System

Columbia, Missouri, United States

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NCT03966027


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