Status:
ACTIVE_NOT_RECRUITING
Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures
Lead Sponsor:
Major Extremity Trauma Research Consortium
Conditions:
Rehabilitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Addi...
Detailed Description
The purpose of this multi-center, randomized controlled trial (RCT) is to compare outcomes following early versus delayed weight bearing among individuals with a traumatic ankle fracture. This study w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04028414
Start Date
January 1 2020
End Date
March 1 2025
Last Update
January 22 2025
Active Locations (17)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
3
Methodist Hospital
Indianapolis, Indiana, United States, 46202
4
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201