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Early vs Delayed Weightbearing After Ankle Fracture Surgery

N/A

Recruiting

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment through 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare early weightbearing after ankle surgery to traditional non-weightbearing to see if it improves outcomes and speeds return to work. Excludes severe ankle injuries and comorbidities.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include increased pain during early movement, risk of re-injury or complications related to putting weight on the operated ankle too soon compared with waiting longer before bearing weight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment through 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment through 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Loss of reduction of the syndesmosis

Olerud Molander

Physical Exam Functional Outcomes

+3 more

Secondary study objectives

Difference in rates of Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early weightbearing (as tolerated) GroupExperimental Treatment1 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 GroupActive Control1 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.

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