Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures
Kyle Schweser MD
25 participants
Aug 1, 2020
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
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
After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace
After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03966027