Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

Description

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
  2. Hemoglobin A1c will also be collected from each patient if it has not been performed within the last 30 days.
  3. Post-operatively a. Post-surgery i. Standard of Care:
  4. Placement into short leg, non-weight bearing splint to allow for wound healing and brace fabrication ii. Research Specific:
  5. 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:
  6. Placed into compression stockings
  7. Counseling regarding skin checks and diabetic skin care
  8. Physical therapy prescription given ii. Research Specific
  9. 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.
  10. 3 Week visit (not standard of care timepoint) i. Research Specific
  11. Ankle radiographs d. 4 weeks, 6 weeks, 12 Weeks, 26 weeks, and 1 year visits (standard of care time points) i. Standard of Care
  12. Surveys (PROMIS, AAOS Foot and Ankle)
  13. Ankle Radiographs ii. Research Specific
  14. 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
  15. Ankle Radiographs (if early failure is suspected)
  16. 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

Eligibility

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

Study details
    Ankle Fractures

NCT03966027

Kyle Schweser MD

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.