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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2026-06-15

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

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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

1. Pre-operatively

a. Hemoglobin A1c will also be collected from each patient if it has not been performed within the last 30 days.
2. 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:

1. Placed into compression stockings
2. Counseling regarding skin checks and diabetic skin care
3. 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

1. Surveys (PROMIS, AAOS Foot and Ankle)
2. 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

1. Ankle Radiographs (if early failure is suspected)
2. 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

Conditions

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Ankle Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Postoperative protocol (Immediate weight bearing)

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Postoperative Protocol (Delayed Weight Bearing)

Intervention Type OTHER

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

Interventions

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Postoperative 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

Intervention Type OTHER

Postoperative Protocol (Delayed Weight Bearing)

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Children
2. Pregnant patients
3. No signs of diabetes complicated by neuropathy
4. Non-operative ankle fractures
5. Multiple extremity injury
6. Cannot follow post-operative protocol
7. Chronic ankle fractures receiving surgery beyond 3 weeks of injury

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No