Early vs Delayed Weight-Bearing for Ankle Injury

No longer recruiting at 1 trial location
SB
SC
Overseen ByStacee Clawson, BSN, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kyle Schweser MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the optimal timing for weight-bearing on a surgically fixed ankle with syndesmotic disruption. Researchers compare two groups: one begins early weight-bearing two weeks post-surgery, while the other starts late weight-bearing at six weeks. The goal is to determine if earlier weight-bearing affects recovery, pain, and return to daily activities. Ideal participants are adults with an ankle fracture requiring a suture button fix, who were able to walk before the injury. As an unphased trial, this study allows participants to contribute to valuable research that could enhance recovery strategies for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that starting to put weight on the ankle soon after surgery is safe. Studies have found that patients who begin walking on their ankle just two weeks post-surgery do not experience more problems than those who wait longer. In fact, one study found that starting early can lead to better movement and recovery without additional risks.

For patients with ankle fractures requiring extra support, such as a special button to hold things in place, early weight-bearing is also safe. This approach has not been associated with major problems.

Waiting longer before putting weight on the ankle does not appear to enhance safety. Studies have shown that waiting does not reduce complications more than starting early.

In summary, both starting early and waiting are safe options after certain ankle surgeries, but starting early may aid in better recovery.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the timing of weight-bearing after ankle surgery, a crucial factor in recovery. Typically, the standard care involves waiting several weeks before putting weight on an injured ankle. This trial investigates whether starting weight-bearing earlier—just two weeks after surgery—could lead to faster recovery without compromising healing. By comparing early and delayed weight-bearing, researchers aim to determine the safest and most effective way to speed up recovery and improve outcomes for patients with ankle injuries.

What evidence suggests that this trial's weight-bearing protocols could be effective for ankle injuries?

This trial will compare early weight-bearing with delayed weight-bearing for ankle injuries. Research has shown that starting to put weight on the ankle soon after surgery can speed up recovery and improve comfort. Participants in the early weight-bearing group will begin walking on their ankle just 2 weeks after surgery. Studies have found that this often leads to returning to work and experiencing less pain sooner than those who wait longer. One study found that early weight-bearing is safe and effective, especially when using a special technique for certain ankle injuries. Another study found that starting to walk on the ankle early does not cause more problems than waiting. Overall, early weight-bearing seems to offer benefits without additional risks.12367

Who Is on the Research Team?

KS

Kyle Schweser, MD

Principal Investigator

University of Missouri Health System, Department of Orthopaedic Surgery

Are You a Good Fit for This Trial?

Adults over 18 who can walk on their own and have an ankle fracture with a suspected syndesmotic injury, likely needing suture button surgery. Not for pregnant or breastfeeding individuals, those under 18, weighing over 325 pounds, prisoners, people unable to follow commands due to conditions like dementia or TBI, patients with end-stage renal disease, severe syndesmotic injuries (Maisonneuve), or neuropathic diabetics.

Inclusion Criteria

I have a broken ankle that may need surgery with a special suture technique.
I can walk on my own before surgery.

Exclusion Criteria

You are currently pregnant or breastfeeding.
Prisoner
I have a specific type of ankle injury.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical suture button fixation for syndesmotic disruption and are randomized into early or delayed weight-bearing groups

6 weeks
Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including maintenance of ankle reduction and secondary outcomes

1 year
Visits at 2 weeks, 6 weeks, 12 weeks, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Delayed/Late Weight-Bearing
  • Early Weight-Bearing
Trial Overview The study is testing if patients with ankle fractures involving the syndesmosis can safely put weight on their foot early (2 weeks after surgery) versus late (6 weeks). They're randomly assigned to one of these two groups. The main goal is seeing if the position of the bones stays correct after a year using CT scans.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Early Weight-BearingActive Control1 Intervention
Group II: Delayed/Late Weight-BearingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kyle Schweser MD

Lead Sponsor

Trials
3
Recruited
120+

Published Research Related to This Trial

Early weight-bearing after common foot and ankle surgeries, such as metatarsophalangeal joint arthrodesis and ankle fractures, is supported by literature as a safe alternative to prolonged immobilization.
Prolonged nonweight bearing can lead to serious complications like deep vein thrombosis and cardiovascular issues, making early weight-bearing protocols a beneficial approach for postoperative recovery.
Early Functional Rehabilitation in Foot and Ankle Surgery.Patel, S., Dionisopoulos, SB., Schmalhaus, MJ.[2023]
Weight bearing (WB) and mobilization (MB) after surgical treatment for ankle fractures do not increase complication rates and lead to better short-term outcomes in terms of ankle function and return to work, based on a systematic review of 24 studies involving 1,559 participants.
Compared to non-weight bearing (NWB) and immobilization (IMB), WB and MB resulted in superior scores on the Olerud and Molander Ankle Score (OMAS) and improved range of motion (ROM), indicating that early activity is beneficial for recovery.
Immediate weight bearing without immobilization for operatively treated ankle fractures is safe - A systematic review.Baumbach, SF., Rellensmann, K., Spindler, FT., et al.[2023]
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

Early weight-bearing after ankle fracture surgery: a systematic ...Patients with EWB returned to work 12.3 weeks earlier and achieved clinically significant pain reduction 6 weeks sooner than delayed weight- ...
Early versus delayed weight-bearing following operatively ...In conclusion, this trial finds that an early weight-bearing strategy is non-inferior to delayed weight-bearing after ankle fracture surgery and ...
Effect of early weight bearing on rehabilitation in ankle ...Recent studies further suggest that early weight-bearing at 2 weeks is feasible for ankle fractures combined with syndesmotic injuries under ...
Comparing immediate and delayed weight bearing in ...Participants in the IWB group will be allowed to weight bear as tolerated within 24 h, while participants in the DWB group will remain non-weight bearing for ...
Early vs Delayed Weight-Bearing for Ankle InjuryResearch shows that early weight-bearing after ankle surgery can lead to better short-term ankle function, although there is no significant difference in long- ...
6.journal.aoao.orgjournal.aoao.org/?p=641
Early Weight Bearing After Syndesmosis Fixation for Ankle ...This study showcases that early weight-bearing in patients with ankle fractures requiring syndesmotic fixation is safe with no difference in complications and ...
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.
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