450 Participants Needed

Early Weight Bearing for Ankle Fracture

Recruiting at 19 trial locations
EW
Overseen ByELIZABETH WYSOCKI, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Major Extremity Trauma Research Consortium
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study.

Do I have to stop taking my current medications for the trial?

The protocol does not specify if you need to stop taking your current medications. However, if you are on osteoporosis medications like bisphosphonates, Prolia, or Forteo, you are not eligible for the trial.

What safety data exists for early weight bearing after ankle fracture?

Several studies suggest that early weight bearing after ankle fracture fixation can be safe for certain patients. Immediate weight-bearing as tolerated (IWBAT) showed low complication rates, with only 1 out of 26 patients experiencing loss of fixation due to a missed injury. Other studies found no significant differences in long-term outcomes between early and delayed weight bearing, although early weight bearing improved short-term ankle function. However, early mobilization may increase the risk of postoperative complications. Overall, early weight bearing can be a safe alternative for specific fracture patterns, but further research is needed to refine protocols.12345

Is Early Weight Bearing a promising treatment for ankle fractures?

Yes, Early Weight Bearing is a promising treatment for ankle fractures. It allows patients to walk and return to daily activities faster, improves short-term ankle function, and is generally safe without increasing long-term complications.12456

What data supports the idea that Early Weight Bearing for Ankle Fracture is an effective treatment?

The available research shows that Early Weight Bearing (EWB) for ankle fractures can be effective. One study found that patients who started walking immediately after surgery had better short-term ankle function compared to those who waited. Another study reported that most patients could wear normal shoes just six weeks after surgery, with only one out of 26 patients experiencing a problem with the surgical fix. Additionally, a review of several studies found no significant long-term differences between early and delayed weight bearing, suggesting that EWB can be a safe option. Overall, these studies indicate that EWB can help patients recover faster without increasing the risk of complications.12456

Who Is on the Research Team?

LR

Lisa Reider, PhD

Principal Investigator

Major Extremity Trauma Research Consortium

Are You a Good Fit for This Trial?

Adults over 18 with certain types of ankle or tibial plateau fractures that have been surgically treated can join this trial. Excluded are those with severe soft tissue injuries, syndesmotic injuries, upper limb weight-bearing limitations, morbid obesity (BMI ≥40), psychiatric disorders affecting compliance, and other conditions like neuropathy or osteoporosis.

Inclusion Criteria

I had surgery for a specific type of broken ankle or lower leg bone.

Exclusion Criteria

I have severe burns on more than 10% of my body, including the limb being studied.
I have injuries that prevent me from putting weight on my arms or legs.
I have nerve damage or a broken bone due to cancer.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants are randomized to early versus delayed weight bearing and receive standardized exercises

6 weeks
1 visit (in-person) at 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment with evaluations at 3, 6, and 12 months

12 months
3 visits (in-person) at 3 and 6 months, 1 visit (phone) at 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Early Weight Bearing
Trial Overview The study is examining the effects of allowing patients to put weight on their leg early after surgery for an ankle fracture without syndesmotic fixation or a specific type of tibial plateau fracture. It compares early versus delayed weight bearing in terms of rehabilitation outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Weight BearingExperimental Treatment1 Intervention
Group II: Delayed Weight BearingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Major Extremity Trauma Research Consortium

Lead Sponsor

Trials
32
Recruited
27,400+

Published Research Related to This Trial

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.
Immediate weight-bearing after ankle fracture fixation.Firoozabadi, R., Harnden, E., Krieg, JC.[2020]
Early weight-bearing after certain lower extremity fractures, particularly in patients with normal protective sensation, can be safe and beneficial, as shown by randomized controlled trials of ankle fractures with no significant outcome differences between immediate and delayed weight bearing.
While immediate weight bearing has low complication rates in specific cases like femoral shaft fractures, the evidence for early weight bearing is less strong for other fracture types, such as periarticular fractures, indicating a need for more research to establish optimal protocols.
Early weight bearing after lower extremity fractures in adults.Kubiak, EN., Beebe, MJ., North, K., et al.[2022]
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.
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]

Citations

Immediate weight-bearing after ankle fracture fixation. [2020]
Early weight bearing after lower extremity fractures in adults. [2022]
Early Versus Delayed Weight Bearing and Mobilization After Ankle Fracture Fixation Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]
Safety of early weightbearing after ankle fracture fixation. [2023]
Successful immediate weight-bearing of internal fixated ankle fractures in a general population. [2022]
Quality of life and complications in elderly patients after pronation rotation type III ankle fractures treated with a cast and early weight-bearing. [2021]
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