Early Weight Bearing for Ankle Fracture

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

450 Participants Needed

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 5}

Research Team

Lisa Reider, PhD

Principal Investigator

Major Extremity Trauma Research Consortium

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

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 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]

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]

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 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]

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 weight bearing after lower extremity fractures in adults. [2022]

3. 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]

4. France pubmed.ncbi.nlm.nih.gov

Safety of early weightbearing after ankle fracture fixation. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

Successful immediate weight-bearing of internal fixated ankle fractures in a general population. [2022]

6. England 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. [2021]