Immediate vs. Delayed Weight Bearing After Surgery for Diabetic Ankle Fracture

(Diabetic Ankle Trial)

Overseen By Vicki L Jones, MEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kyle Schweser MD

Disqualifiers: Children, Pregnant, Multiple injuries, others

Compensation: Varies

Number of Visits: 2

25 Participants Needed

Trial Summary

What is the purpose of 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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of immediate vs. delayed weight bearing after surgery for diabetic ankle fracture?

Research shows that early weight bearing after ankle surgery can lead to faster recovery and improved short-term ankle function, although it may increase the risk of complications. In diabetic patients, prolonged non-weight bearing may reduce complications, suggesting a careful balance is needed for optimal outcomes. ^{1 2 3 4 5}

Is immediate weight bearing after ankle surgery safe?

Immediate weight bearing after ankle surgery appears to be generally safe for certain patients, with only minor complications like skin redness that resolved with antibiotics. Early weight bearing can improve short-term ankle function, but there may be a higher risk of complications compared to delayed weight bearing. ^{1 2 4 5 6}

How does the treatment of immediate vs. delayed weight bearing after surgery for diabetic ankle fracture differ from other treatments?

This treatment is unique because it explores the timing of weight bearing after surgery, comparing immediate weight bearing, which may help patients return to daily activities faster, with delayed weight bearing, which is traditionally used to reduce complications in diabetic patients. Immediate weight bearing can improve short-term ankle function, but delayed weight bearing may reduce postoperative complications in patients with complicated diabetes. ^{1 2 3 5 7}

Research Team

Kyle M Schweser, MD

Principal Investigator

Assistant Professor Orthopaedic Trauma/Foot and Ankle

Eligibility Criteria

This trial is for adults over 18 with diabetes who have recently had surgery for an ankle fracture. They must be under 275 pounds, able to use a brace, and not have other foot deformities or multiple injuries. It's not suitable for pregnant individuals, children, those unable to follow the protocol, or if neuropathy complicates their diabetes.

Inclusion Criteria

I have a broken ankle (not the lower part) and will have surgery within 3 weeks of the injury.

I weigh less than 275 pounds (124 kg).

Can tolerate and comply with brace

Exclusion Criteria

I have injuries to more than one limb.

Cannot follow post-operative protocol

I have a broken ankle that doesn't require surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Pre-operative

Pre-operative assessments including Hemoglobin A1c collection if not performed within the last 30 days

1 week

Post-operative

Post-surgery care including placement into a non-weight bearing splint, brace fitting, and subsequent visits for brace adjustments and radiographs

26 weeks

Visits at 2, 3, 4, 6, 8, 10, 12, 14, 16, 26 weeks, and 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and radiographs

12 months

Treatment Details

Interventions

• Postoperative Protocol (Delayed Weight Bearing)
• Postoperative Protocol (Immediate weight bearing)

Trial Overview The study compares two post-surgery care methods for diabetic patients with ankle fractures: one group will start putting weight on their foot right away using a special brace; the other will delay weight bearing according to traditional protocols. The goal is to see which method leads to better movement and satisfaction without increasing complications.

Participant Groups

Group I: Hindfoot Offloading Braces / Immediate Weight-bearing Experimental Treatment 1 Intervention

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 II: No Hindfoot Offloading Braces / Delayed Weight-Bearing Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Kyle Schweser MD

Lead Sponsor

Trials

3

Recruited

120+

Findings from Research

A study of 26 patients who underwent surgery for unstable ankle fractures showed that allowing immediate weight-bearing as tolerated (IWBAT) can be safe, with only one case of fixation loss attributed to a missed injury.

Most patients (20 out of 26) were able to wear normal shoes by the 6-week follow-up, suggesting that IWBAT may facilitate faster recovery and rehabilitation compared to traditional protected weight-bearing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate weight-bearing after ankle fracture fixation. Firoozabadi, R., Harnden, E., Krieg, JC.[2020]

Early weight-bearing after common foot and ankle surgeries, such as metatarsophalangeal joint arthrodesis and ankle fractures, is supported by literature as a safe alternative to prolonged immobilization.

Prolonged nonweight bearing can lead to serious complications like deep vein thrombosis and cardiovascular issues, making early weight-bearing protocols a beneficial approach for postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Functional Rehabilitation in Foot and Ankle Surgery. Patel, S., Dionisopoulos, SB., Schmalhaus, MJ.[2023]

In a study of 90 patients with complicated diabetic ankle fractures, those who maintained prolonged non-weightbearing status (≥ 8 weeks) showed a trend towards fewer postoperative complications (29.2% vs 39.4%), although this was not statistically significant.

Higher creatinine levels were identified as a significant risk factor for developing postoperative complications, with a one-unit increase in creatinine associated with a 3.15-fold increase in complications, highlighting the importance of monitoring kidney function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operative Ankle Fractures in Complicated Diabetes: Outcomes of Prolonged Non-Weightbearing. Brutico, AG., Nasser, EM., Brutico, JM.[2022]

This study will compare an early permissive weight bearing rehabilitation protocol to the standard non-weight bearing guidelines for patients with surgically treated lower extremity fractures, involving a multicenter cohort of patients over a 12-month inclusion period and 6 months of follow-up.

The primary outcome will assess daily living activities using the Lower Extremity Functional Scale, aiming to determine if the permissive weight bearing approach is more effective and cost-efficient than traditional non-weight bearing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study. Kalmet, PHS., Meys, G., V Horn, YY., et al.[2018]

Early weight bearing after ankle surgery leads to better short-term ankle function scores at 12 weeks, suggesting it may be beneficial for recovery in the initial phase.

However, despite these short-term benefits, there were no significant differences in overall ankle function at 1 year post-surgery between early and delayed weight bearing, and early mobilization was associated with a higher risk of postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Versus Delayed Weight Bearing and Mobilization After Ankle Fracture Fixation Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Tong, J., Ajrawat, P., Chahal, J., et al.[2023]

In a study of 69 patients with unstable ankle fractures, those following an immediate weightbearing (IWB) protocol returned to work significantly earlier than those on a traditional weightbearing (TWB) protocol, with an average difference of 4.3 weeks for nonsedentary jobs.

The IWB group demonstrated a statistically significant 2.25-week earlier return to work after adjusting for various factors, suggesting that immediate weightbearing may enhance recovery and facilitate quicker reintegration into the workforce.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Weightbearing After Operative Treatment of Bimalleolar and Trimalleolar Ankle Fractures: Faster Return to Work for Patients with Nonsedentary Occupations. Cunningham, BP., Dugarte, AJ., McCreary, DL., et al.[2021]

Weight bearing (WB) and mobilization (MB) after surgical treatment for ankle fractures do not increase complication rates and lead to better short-term outcomes in terms of ankle function and return to work, based on a systematic review of 24 studies involving 1,559 participants.

Compared to non-weight bearing (NWB) and immobilization (IMB), WB and MB resulted in superior scores on the Olerud and Molander Ankle Score (OMAS) and improved range of motion (ROM), indicating that early activity is beneficial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate weight bearing without immobilization for operatively treated ankle fractures is safe - A systematic review. Baumbach, SF., Rellensmann, K., Spindler, FT., et al.[2023]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Immediate weight-bearing after ankle fracture fixation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Early Functional Rehabilitation in Foot and Ankle Surgery. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Operative Ankle Fractures in Complicated Diabetes: Outcomes of Prolonged Non-Weightbearing. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Early Versus Delayed Weight Bearing and Mobilization After Ankle Fracture Fixation Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Immediate Weightbearing After Operative Treatment of Bimalleolar and Trimalleolar Ankle Fractures: Faster Return to Work for Patients with Nonsedentary Occupations. [2021]

7. France pubmed.ncbi.nlm.nih.gov

Immediate weight bearing without immobilization for operatively treated ankle fractures is safe - A systematic review. [2023]