Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures

Completed · Not applicable

Conditions studied: Rehabilitation

In brief

The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study.

Key facts

Study ID

NCT04028414

Run by

Major Extremity Trauma Research Consortium

People needed

435

Starts

2020-01-01

Expected to finish

2024-12-23

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults ages 18 or older
• Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria:
• bimalleolar fracture requiring fixation of any two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
• bimalleolar equivalent SER4 fractures (lateral malleolus fracture requiring fixation and no medial or posterior malleolus fixation)
• trimalleolar fracture with fixation of at least two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
• Operative treatment of an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.

You may not qualify if…

• Gustilo Type III injuries or soft tissue injury of either lower extremity that would contra-indicate immediate or delayed WB
• Syndesmotic injuries/fixation
• Osteoporosis as defined by treatment with a bisphosphonate and/or other osteoporosis medications, including Prolia and Forteo; or a prior fragility fracture (e.g., spine compression, proximal humerus, distal radius, femoral neck/intertrochanteric fracture)
• Neuropathy, defined as diagnosis of peripheral neuropathy in medical record, neuropathic foot ulcer, or diminished or absent plantar sensation to light touch.
• Pathologic fracture related to neoplasm
• Fractures and dislocations to the ipsilateral or contralateral lower limb that prevent weight bearing as tolerated after fist post-op visit
• Other contra-indication to immediate or delayed weight bearing (e.g., ipsilateral fracture effecting weight bearing status such as a calcaneus fracture); fractures of the ipsilateral lower extremity that would not affect WB status may be included (e.g., proximal femur, femoral shaft or tibia shaft fractures)
• Any upper limb injury that would limit upper extremity weight bearing (e.g., surgical neck fracture of proximal humerus)
• Injuries to other body systems that would affect the ability to comply with either WB protocol (e.g., spinal cord injury; severe TBI; major abdominal or chest injury)
• Patient has third degree burns on >10% total surface area affecting the study limb
• Tibial plateau fractures that are required to wear a locking brace or fractures that require fixed immobilization beyond four weeks (e.g., cast)
• Non-ambulatory pre-injury
• Pre-injury limitation to ROM of ipsilateral hip, knee or ankle
• Morbidly obese (BMI ≥40)
• Documented psychiatric disorder requiring admission in perioperative period
• Severe problems with maintaining follow-up (e.g., patients who are prisoners or homeless at the time of injury or who are intellectually challenged without adequate family support)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• University of Maryland R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Hennepin County Medical Center / Regions Hospita — Minneapolis, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• San Antonio Military Medical Center (SAMMC) — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• University of Washington/Harborview Medical Center — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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