Early Weight Bearing for Ankle Fracture

Not currently recruiting at 19 trial locations

Overseen By ELIZABETH WYSOCKI, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Major Extremity Trauma Research Consortium

Must not be taking: Bisphosphonates, Prolia, Forteo

Disqualifiers: Osteoporosis, Neuropathy, Morbid obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether starting to walk sooner or later after surgery benefits recovery for certain ankle and knee fractures. The goal is to determine if early weight bearing (walking soon after surgery) speeds up recovery without increasing harm. Patients who have undergone surgery for specific ankle or knee fractures and wish to start walking again may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance recovery strategies for future patients.

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 prior data suggests that early weight bearing is safe for ankle and plateau fractures?

Research has shown that starting to put weight on the ankle soon after surgery is generally safe. A review of studies found that patients who began walking earlier did not experience more problems than those who waited longer. One study found that starting to walk just two weeks after surgery was safe and feasible.

Additionally, a large study found no increased risk of complications for patients who started walking early compared to those who waited. Most importantly, these studies suggest that early walking is well-tolerated, meaning most people can do it without serious issues. Therefore, for those considering joining a trial for early walking, research supports the safety of this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the early weight-bearing protocol for ankle fractures because it challenges the traditional approach of delayed weight bearing, which typically involves keeping most weight off the injured ankle for several weeks. This new method encourages patients to start bearing weight as tolerated much earlier while using a boot, potentially speeding up recovery and improving mobility. By promoting a heel-to-toe normal gait sooner, it aims to enhance rehabilitation outcomes and reduce the time patients rely on assistive devices like crutches or walkers. If successful, this approach could revolutionize the standard care for ankle fractures by emphasizing a more active recovery process.

What evidence suggests that early weight bearing is effective for ankle fractures?

Research has shown that starting to put weight on the ankle soon after surgery can speed up recovery. In this trial, some participants will follow an Early Weight Bearing approach, beginning to walk as tolerated shortly after surgery. Specifically, patients who began walking earlier returned to work about 12.3 weeks sooner and experienced less pain six weeks earlier than those who waited. Studies also find that early weight bearing improves ankle movement after surgery. This method proves effective even for more complicated ankle fractures. Overall, starting to walk sooner appears to offer both health benefits and a quicker recovery for those healing from ankle fractures. ^{1 2 6 7 8}

Who Is on the Research Team?

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.

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?

Group I: Early Weight Bearing Experimental Treatment 1 Intervention

Patients with ankle fractures will be instructed to weight bear as tolerated (WBAT) while in a boot with a heel to toe normal gait and wean from walker or crutches to a cane or no support device. At the 6 week post op visit, patients with ankle fractures will be instructed to wean from the boot and continue full weight bearing as tolerated until full weight bearing is achieved. Patients with plateau fractures will be instructed to begin WBAT until full weight bearing is achieved.

Group II: Delayed Weight Bearing Active Control 1 Intervention

Patients with ankle fractures will be instructed to touch-down (toe touch or foot flat) weight bear (approximately 10% of body weight) while in the boot for. Patients will be instructed to keep foot off of floor or set ball of foot or heal on ground for balance using walker or crutches at all times. After the 6 week post op visit, patients may begin weight bearing as tolerated. Patients with tibial plateau fractures will be instructed to touch down (toe touch or foot flat) weight bear (approximately 10% of body weight) for at least 6 weeks. After the 6 week post op visit, patients may begin weight bearing as tolerated until full weight bearing is achieved.

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 involving 174 patients with ankle fractures found that starting weightbearing at two weeks post-surgery did not lead to a higher complication rate compared to waiting six weeks, suggesting that early weightbearing is safe.

Early weightbearing may enhance patient independence and quality of life without negatively impacting recovery, making it a beneficial option for suitable patients after ankle fracture fixation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of early weightbearing after ankle fracture fixation. de Sa, R., Shah, N., Rudge, B., 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 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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early weight bearing after lower extremity fractures in adults. Kubiak, EN., Beebe, MJ., North, K., et al.[2022]

A study of 62 patients with ankle fractures showed that allowing full immediate weight-bearing after surgery is safe and does not increase complication rates, even in an elderly population (median age 55).

The new regimen, which replaced 3 weeks of non-weight-bearing with immediate weight-bearing, resulted in no reoperations and only one case of minor radiographic widening of the ankle joint, suggesting it is an effective approach for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful immediate weight-bearing of internal fixated ankle fractures in a general population. Harager, K., Hviid, K., Jensen, CM., et al.[2022]

A study involving 62 elderly patients with nondisplaced pronation rotation type III ankle fractures showed that early weight-bearing significantly improved quality of life and functionality compared to non-weight-bearing, with notable increases in SF-12 and Barthel Index scores over two years.

Patients in the early weight-bearing group experienced better outcomes at both six weeks and two years, indicating that this approach is both effective and safe for enhancing recovery in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and complications in elderly patients after pronation rotation type III ankle fractures treated with a cast and early weight-bearing. Lorente, A., Gandía, A., Mariscal, G., et al.[2021]

Citations

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