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Early Weight Bearing for Ankle Fracture

N/A

Recruiting

Led By Lisa Reider, PhD

Research Sponsored by Major Extremity Trauma Research Consortium

Eligibility Criteria Checklist

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

Must have

Surgically treated open or closed fractures of the ankle meeting specific criteria: bimalleolar fracture requiring fixation of any two malleoli, bimalleolar equivalent SER4 fractures, trimalleolar fracture with fixation of at least two malleoli, operative treatment of an isolated lower extremity unicondylar tibial plateau fracture without joint impaction

Be older than 18 years old

Must not have

Third degree burns on >10% total surface area affecting the study limb

Fractures and dislocations to the lower limb affecting weight bearing, upper limb injuries limiting weight bearing, injuries to other body systems affecting compliance with weight bearing protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it's better to wait or start bearing weight immediately after surgery for an ankle fracture.

Who is the study for?

Adults over 18 with certain types of ankle or tibial plateau fractures that have been surgically treated can join this trial. Excluded are those with severe soft tissue injuries, syndesmotic injuries, upper limb weight-bearing limitations, morbid obesity (BMI ≥40), psychiatric disorders affecting compliance, and other conditions like neuropathy or osteoporosis.

What is being tested?

The study is examining the effects of allowing patients to put weight on their leg early after surgery for an ankle fracture without syndesmotic fixation or a specific type of tibial plateau fracture. It compares early versus delayed weight bearing in terms of rehabilitation outcomes.

What are the potential side effects?

Since the intervention involves early weight bearing rather than medication, side effects may include pain at the injury site, potential stress to healing bones or joints, and risk of re-injury if the bone has not healed sufficiently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery for a specific type of broken ankle or lower leg bone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe burns on more than 10% of my body, including the limb being studied.

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I have injuries that prevent me from putting weight on my arms or legs.

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I have nerve damage or a broken bone due to cancer.

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I have osteoporosis, confirmed by medication use or a past weak-bone fracture.

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I have had surgery to fix an injury in my ankle joint.

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I have a severe injury to my leg that prevents me from putting weight on it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Study Related Complications Experienced

Return to Usual Major Activity and Work Productivity

Secondary study objectives

Joint Range of Motion (ROM)

Pain Interference

Pain Score

+1 more

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 Weight BearingExperimental Treatment1 Intervention

Patients with ankle fractures will be instructed to weight bear as tolerated (WBAT) while in a boot with a heel to toe normal gait and wean from walker or crutches to a cane or no support device. At the 6 week post op visit, patients with ankle fractures will be instructed to wean from the boot and continue full weight bearing as tolerated until full weight bearing is achieved. Patients with plateau fractures will be instructed to begin WBAT until full weight bearing is achieved.

Group II: Delayed Weight BearingActive Control1 Intervention

Patients with ankle fractures will be instructed to touch-down (toe touch or foot flat) weight bear (approximately 10% of body weight) while in the boot for. Patients will be instructed to keep foot off of floor or set ball of foot or heal on ground for balance using walker or crutches at all times. After the 6 week post op visit, patients may begin weight bearing as tolerated. Patients with tibial plateau fractures will be instructed to touch down (toe touch or foot flat) weight bear (approximately 10% of body weight) for at least 6 weeks. After the 6 week post op visit, patients may begin weight bearing as tolerated until full weight bearing is achieved.

0 / 7Eligibility criteria met