Health TrialsbyHealthPanel

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

ConditionAnkle Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKyle Schweser MD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 and ove

Positive for diabetes

Positive monofilament test

Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture

Disqualifiers

Children

Pregnant patients

No signs of diabetes complicated by neuropathy

Non-operative ankle fractures

Trial design

Design model

Parallel

Treatments tested in this trial

  • Postoperative protocol (Immediate weight bearing)

    Other intervention

    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 intervention

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

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Hindfoot Offloading Braces / Immediate Weight-bearingExperimental treatment 1 intervention
Group B: No Hindfoot Offloading Braces / Delayed Weight-BearingPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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: 1. Severity; 2. Unanticipated Adverse Device Effect (UADE) 3. Seriousness (Serious Adverse Event (SAE), Non-serious AE); 4. Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); 5. Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 Months
2

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).

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyle Schweser MD

Lead sponsor

University of Missouri-Columbia

Sponsor institution

Source ClinicalTrials.gov
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