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

Part of paid clinical trials in Columbia, Missouri.

Sponsor
Kyle Schweser MD
Study ID
NCT03966027
Status
Recruiting
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Conditions

  • Ankle Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Postoperative protocol (Immediate weight bearing) — OTHER
    After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace
  • Postoperative Protocol (Delayed Weight Bearing) — OTHER
    After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol

Study Details

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

Key Dates

Start date
Aug 1, 2020
Status verified
Aug 2025
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hindfoot Offloading Braces / Immediate Weight-bearing
    Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event
  • Placebo Comparator: No Hindfoot Offloading Braces / Delayed Weight-Bearing
    Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event

Primary Outcome Measure

Adverse Events [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Missouri Health SystemColumbiaMissouri65212
Stacee Clawson, BSN, RN
[email protected]
573-884-9017

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By research site
University of Missouri Health System· Columbia, MO

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