Early vs Delayed Weightbearing After Ankle Fracture Surgery

Overseen By Anna Valencia, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Previous ankle surgery, Bilateral fractures, Peripheral neuropathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether beginning weightbearing on an ankle soon after surgery aids in faster recovery and quicker return to work compared to a delayed approach. It targets patients who have undergone surgery for specific unstable ankle injuries, such as certain fractures or ligament tears. Participants will be divided into two groups: one will follow the traditional slow approach to weightbearing (Delayed Weightbearing management post-operation), while the other will begin weightbearing earlier (Early Weightbearing management post-operation). Ideal candidates are those who have had surgery on a single ankle within two weeks of the injury and have not undergone previous surgery on that ankle. As an unphased trial, it provides a unique opportunity to enhance understanding of recovery methods and potentially benefit from faster rehabilitation.

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 these weightbearing protocols are safe for post-operative ankle fracture patients?

Research shows that starting to put weight on an ankle soon after surgery for a fracture is usually safe. Studies have found that walking on the ankle just two weeks post-surgery is both safe and practical. One study found that this approach can lead to better recovery without increasing the risk of problems. Another study confirmed that for generally healthy individuals, walking on the ankle within three weeks after surgery did not cause complications. Overall, early weightbearing appears to be a safe option for most people after ankle surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether starting weightbearing activities early after ankle fracture surgery could enhance recovery compared to the traditional approach. Typically, patients are advised to avoid putting weight on the ankle for several weeks post-surgery. This trial is testing if allowing patients to start weightbearing as soon as they feel comfortable could lead to faster rehabilitation and improved mobility. By potentially shortening recovery time and improving outcomes, this approach might represent a significant shift in post-operative care for ankle fractures.

What evidence suggests that early weightbearing management post operation could be effective for ankle fracture recovery?

This trial will compare early versus delayed weightbearing after ankle fracture surgery. Research has shown that beginning weightbearing soon after surgery can be beneficial. Studies have found that it improves ankle function and speeds up recovery. Participants in the early weightbearing group, who begin walking shortly after surgery, demonstrated similar mobility and recovery outcomes as those in the non-weightbearing group, who wait longer, without increased complications. This early approach also improved their quality of life. Overall, starting weightbearing early is considered safe and can help individuals return to daily activities sooner. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who've had surgery to fix an unstable ankle fracture with syndesmosis disruption within two weeks of injury. They must be able to bear weight on the affected leg and not have severe open fractures, other major injuries, a very high BMI, previous ankle surgeries on the same side, or conditions that prevent following post-op instructions.

Inclusion Criteria

I have a severe ankle injury involving the syndesmosis ligament.

I had surgery on my ankle or the connecting tissue within two weeks of getting hurt.

My fracture is either closed or a minor open wound without serious contamination.

Exclusion Criteria

I have had surgery on the same ankle before.

I do not have numbness, tingling, or pain in my hands or feet.

I have a fracture in the lower part of my shinbone affecting the joint.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical fixation of unstable ankle fractures with syndesmosis disruption, followed by either early or delayed weightbearing protocols

6-12 weeks

Weekly visits for physical examination and radiographic assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including functional outcomes and adverse events

1 year

Regular follow-up visits for assessments and questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Delayed Weightbearing management post operation (Traditional)
• Early Weightbearing management post operation

Trial Overview The study compares early versus delayed weightbearing after surgical fixation of unstable ankle fractures. It aims to see if starting to put weight on the foot soon after surgery leads to better function, faster return to work, and how it affects complication rates.

How Is the Trial Designed?

Group I: Early weightbearing (as tolerated) Group Experimental Treatment 1 Intervention

At 0 weeks to 2 weeks post operation, subjects will be provided CAM (controlled ankle motion walking) boot and instructed to be non-weightbearing on the ankle, using crutches for assistance. During 2nd week, subject will visit clinic where staples/stitches will be removed, with instructions to be weightbearing as tolerated. Instructions for limited range of motion to be given, passive/active range of motion out of boot will be allowed. Between 2 to 6 weeks, subject will continue with weightbearing as tolerated in orthosis, following range of motion instructions. After 6 weeks, the subject will continue with weightbearing as tolerated, and be weaned from orthosis. At each follow-up visit, as part of the subject's standard of care, a physical examination and radiographic assessments will be completed, and that data collected for research purposes. Subject will also be requested to complete outcome questionnaires during their participation.

Group II: Non-weightbearing Group Active Control 1 Intervention

At 0 weeks to 2 weeks post operation, subjects will be provided CAM (controlled ankle motion walking) boot and instructed to be non-weightbearing on the ankle, using crutches for assistance. During 2nd week, subject will visit clinic where staples/stitches will be removed, with instructions to continue non-weightbearing w/ crutches. Instructions for limited range of motion to be given, passive/active range of motion out of boot will be allowed. Between 2 to 6 weeks, the subject will continue with non-weightbearing and follow range of motion instructions. After 6 weeks, the subject will begin weightbearing as tolerated. Instructions for limited range of motion to be given, and be weaned from orthosis. At each follow-up visit, as part of the subject's standard of care, a physical examination and radiographic assessments will be completed, and that data collected for research purposes. Subject will also be requested to complete outcome questionnaires during their participation.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

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]

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]

Citations

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

Early weight-bearing after ankle fracture surgery: a systematic ... This systematic review and meta-analysis evaluated the efficacy and safety of early versus delayed weight-bearing following operative treatment ...

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

Early versus delayed weight-bearing following operatively ... Results from the base-case analysis indicated that early weight-bearing following ankle fracture surgery resulted in QALY gains (mean adjusted ...

3. nature.com nature.com/articles/s41598-025-18920-z

Effect of early weight bearing on rehabilitation in ankle ... This study shows that early weight bearing initiated 2 weeks post-surgery is safe and feasible in patients sustaining ankle fractures with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11080868/

The effect of early weight‐bearing and later ... The results showed that early weight bearing is effective in improving ankle function among post‐operative ankle fracture patients and allows patients to ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138325000178

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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40841661/

Early weight-bearing after ankle fracture surgery Conclusions: Early weight-bearing following ankle fracture surgery results in superior functional outcomes and equivalent safety compared to ...

7. medicine.missouri.edu medicine.missouri.edu/news/no-complications-associated-early-weight-bearing-broken-ankles

No Complications Associated with Early Weight Bearing on ... Study found generally healthy patients can put weight on ankles less than three weeks after surgical intervention.