Early vs Delayed Weight-Bearing for Ankle Injury
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgical suture button fixation for syndesmotic disruption and are randomized into early or delayed weight-bearing groups
Follow-up
Participants are monitored for safety and effectiveness after treatment, including maintenance of ankle reduction and secondary outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Delayed/Late Weight-Bearing
- Early Weight-Bearing
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kyle Schweser MD
Lead Sponsor