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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

No study has prospectively compared a traditional post-operative non-weightbearing protocol versus early post-operative weightbearing as tolerated for unstable ankle injuries after surgical fixation of the syndesmosis. This prospective study will attempt to determine if early weightbearing can improve functional outcomes, result in a quicker return to work, and monitor differences in rates of adverse events. It will exclude the most severe ankle injuries and patients with excluding comorbidities.

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 data supports the effectiveness of early weightbearing treatment after ankle fracture surgery?

Research shows that early weightbearing after ankle fracture surgery can lead to better short-term ankle function and a faster return to work for people with physically demanding jobs, without negatively affecting long-term outcomes. ^{1 2 3 4 5}

Is early weightbearing after ankle fracture surgery safe?

Research shows that early weightbearing after ankle fracture surgery is generally safe and can improve short-term ankle function, although there may be a slightly increased risk of complications compared to delayed weightbearing. ^{1 2 3 4 5}

How does early weightbearing treatment after ankle fracture surgery differ from traditional methods?

Early weightbearing after ankle fracture surgery allows patients to start putting weight on their ankle sooner, typically before six weeks, which can lead to better short-term ankle function compared to the traditional method of keeping the ankle non-weightbearing for at least six weeks. This approach may improve recovery speed without negatively affecting long-term outcomes. ^{1 2 3 4 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. 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]

2. France pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Effect on Overall Health Status With Weightbearing at 2 Weeks vs 6 Weeks After Open Reduction and Internal Fixation of Ankle Fractures. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Functional treatment and early weightbearing after an ankle fracture: a prospective study. [2006]

5. United States 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. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

[Aftercare following surgical treatment of ankle fractures : What is the current state of knowledge?] [2022]