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

Ankle Fractures Clinical Trial

— Diabetic Ankle  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966027
• Other study ID #: 2014997
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: June 15, 2025

Study information

• Verified date: July 2023
• Source: University of Missouri-Columbia
• Contact: Vicki L Jones, MEd
• Phone: 573-882-7583
• Email: jonesvicki[@]umsystem.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
United States	University of Missouri Health System	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Kyle Schweser MD

Country where clinical trial is conducted

United States, 

References & Publications (5)

Holder CG, Haskvitz EM, Weltman A. The effects of assistive devices on the oxygen cost, cardiovascular stress, and perception of nonweight-bearing ambulation. J Orthop Sports Phys Ther. 1993 Oct;18(4):537-42. doi: 10.2519/jospt.1993.18.4.537. — View Citation

Jani MM, Ricci WM, Borrelli J Jr, Barrett SE, Johnson JE. A protocol for treatment of unstable ankle fractures using transarticular fixation in patients with diabetes mellitus and loss of protective sensibility. Foot Ankle Int. 2003 Nov;24(11):838-44. doi: 10.1177/107110070302401106. — View Citation

Raghav A, Khan ZA, Labala RK, Ahmad J, Noor S, Mishra BK. Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always. Ther Adv Endocrinol Metab. 2018 Jan;9(1):29-31. doi: 10.1177/2042018817744513. Epub 2017 Dec 12. — View Citation

Shehab DK, Al-Jarallah KF, Abraham M, Mojiminiyi OA, Al-Mohamedy H, Abdella NA. Back to basics: ankle reflex in the evaluation of peripheral neuropathy in type 2 diabetes mellitus. QJM. 2012 Apr;105(4):315-20. doi: 10.1093/qjmed/hcr212. Epub 2011 Nov 8. — View Citation

Wukich DK, Kline AJ. The management of ankle fractures in patients with diabetes. J Bone Joint Surg Am. 2008 Jul;90(7):1570-8. doi: 10.2106/JBJS.G.01673. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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