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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether immediate walking with a special brace after ankle surgery is as safe and effective as delaying weight-bearing. It targets individuals with diabetes who may not normally feel pain and pressure. The goal is to determine if immediate walking aids healing and satisfaction without increasing complications. Ideal participants have diabetes, underwent ankle surgery within the last three weeks, and can use a brace. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance recovery methods for future patients.

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 prior data suggests that this protocol is safe for diabetic patients with ankle fractures?

Research has shown that some patients can safely put weight on their ankle immediately after surgery. One study found that walking without a cast can speed up recovery. In that study, patients reported good results without additional complications. Another study noted minor issues, such as skin redness, which resolved on their own. Overall, these findings suggest that beginning to walk right away can lead to similar recovery outcomes as waiting, without increasing the risk of problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of immediate weight-bearing after surgery for diabetic ankle fractures. Traditionally, patients are advised to delay putting weight on the affected ankle to ensure proper healing. However, this trial is investigating whether immediate weight-bearing, with the help of hindfoot offloading braces, can improve recovery times and patient mobility. If successful, this approach could lead to faster rehabilitation and better overall outcomes for diabetic patients with ankle fractures.

What evidence suggests that this trial's protocols could be effective for diabetic ankle fractures?

This trial will compare two postoperative protocols for diabetic patients with ankle fractures: immediate weight bearing and delayed weight bearing. Research has shown that for diabetic patients with ankle fractures, walking soon after surgery, as in the immediate weight-bearing arm of this trial, can speed up recovery. This approach may also enhance ankle function shortly after surgery. However, some experts worry that walking too soon might lead to complications, such as bones moving out of place or healing issues. Despite these concerns, studies suggest that many patients experience better outcomes with early walking. The goal is to balance faster recovery with the risk of complications, aiming for the best possible results for patients. ^{1 2 4 6 7}

Who Is on the Research Team?

Kyle M Schweser, MD

Principal Investigator

Assistant Professor Orthopaedic Trauma/Foot and Ankle

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12372276/

Early weight-bearing after ankle fracture surgery: a systematic ... Studies have shown that immediate weight-bearing without immobilization can accelerate recovery [13] with patient-reported outcome measures ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03966027

Immediate Vs. Delayed Weight Bearing Postoperative ... Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)00710-4/fulltext

Early versus delayed weight-bearing following operatively ... Some argue that weight-bearing soon after surgery might result in loss of bony alignment, healing problems, and the need for further operations.

4. withpower.com withpower.com/trial/phase-fractures-bone-7-2020-edeb2

Immediate vs. Delayed Weight Bearing After Surgery for ... 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424000516

Comparing immediate and delayed weight bearing in ... Participants in the IWB group will be allowed to weight bear as tolerated within 24 h, while participants in the DWB group will remain non-weight bearing for ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0020138325000178?dgcid=rss_sd_all

Mid to long term follow up of early weightbearing after open ... This study found that early weightbearing after ORIF of unstable ankle fractures leads to similar PROMIS scores and ankle ROM without increased complications.

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/24730114251373087

Early Weightbearing Following Open Reduction and ... Postoperatively, patients were 50% partial weightbearing for 2-3 weeks. Afterward, patients were permitted to bear as much weight as tolerable.