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

Study Overview
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Brief Summary
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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

Detailed Description
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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 Patients will be recruited from the trauma and foot & ankle service lines. Patients who have experienced an isolated ankle fracture (excluding pilon fracture) and will undergo operative fixation within 3 weeks of injury will be approached for consent. Patients will then be screened based on the inclusion and exclusion criteria. Up to 25 patients will be enrolled The following protocol will be applied after enrollment Pre-operatively a. Hemoglobin A1c will also be collected from each patient if it has not been performed within the last 30 days. Post-operatively a. Post-surgery i. Standard of Care: 1. Placement into short leg, non-weight bearing splint to allow for wound healing and brace fabrication ii. Research Specific: 1. Fitted for brace (will be custom made and take approximately 1-2 weeks) b. 2 week visit (standard of care timepoint) i. Standard of Care: Placed into compression stockings Counseling regarding skin checks and diabetic skin care Physical therapy prescription given ii. Research Specific 1. Placement into brace so it offloads the hindfoot to 15 pounds of pressure or less 2. Education by prosthetist, physiatrist, and/or attending physician about proper brace wear and maintenance, and the importance of weight bearing only in brace. c. 3 Week visit (not standard of care timepoint) i. Research Specific 1. Ankle radiographs d. 4 weeks, 6 weeks, 12 Weeks, 26 weeks, and 1 year visits (standard of care time points) i. Standard of Care Surveys (PROMIS, AAOS Foot and Ankle) Ankle Radiographs ii. Research Specific 1. Counseling regarding brace wear 2. Brace adjustments as needed e. 8 week, 10 week, 14 week, 16 week, (non-standard of care biweekly visits until healing occurs) i. Research Specific Ankle Radiographs (if early failure is suspected) Skin Check Upon study completion, patients will continue with post-operative rehab following the surgeon's standard of care. If a patients is removed prematurely or if the study ends prematurely, they will receive standard of care procedures going forward

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

Conditions
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Ankle Fractures

Intervention / Treatment
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* Other: Postoperative protocol (Immediate weight bearing)
* Other: Postoperative Protocol (Delayed Weight Bearing)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Diabetic patients with ankle fractures will be manage operatively and then randomized to be prescribed a hindfoot offloading brace 2 weeks after surgery or be randomized to follow a non-immediate weight bearing rehabilitation protocol
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hindfoot Offloading Braces / Immediate Weight-bearing<br>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 | Other: Postoperative protocol (Immediate weight bearing)<br>* After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace<br>|
| Placebo Comparator: No Hindfoot Offloading Braces / Delayed Weight-Bearing<br>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 | Other: Postoperative Protocol (Delayed Weight Bearing)<br>* After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse Events by type over time, severity, seriousness, and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross-tabulated according to: Severity; Unanticipated Adverse Device Effect (UADE) Seriousness (Serious Adverse Event (SAE), Non-serious AE); Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AAOS Foot and Ankle Score | The AAOS foot and ankle questionnaire is a patient-administrated 25-item survey specifically developed for foot and ankle-related disability. The questionnaire is divided into two scales, the Foot and Ankle Core scale, comprised of 20 questions and the Shoe Comfort Scale with five questions. The questions themselves are distributed among five different categories: Pain (9 items), function (6 items), stiffness and swelling (2 items), giving way (3 items) and shoe comfort (5 items). Answers are then measured on a scale of 1 to 5 or 6, with 1 being the best outcome score. | 12 Months | 
| PROMIS Score | The Patient-Reported Outcomes Measurement Information System® (PROMIS) is a flexible set of tools designed to measure self-reported physical, mental and social health and wellbeing. PROMIS instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The questionarie assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. Norm-based scores are calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10). | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Ankle Fractures