Phase
Condition
N/ATreatment
Early Weight Bearing
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults ages 18 or older
Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meetingone 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 requiringfixation 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 plateaufracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.
Exclusion
Exclusion Criteria:
Gustilo Type III injuries or soft tissue injury of either lower extremity that wouldcontra-indicate immediate or delayed WB
Syndesmotic injuries/fixation
Osteoporosis as defined by treatment with a bisphosphonate and/or other osteoporosismedications, including Prolia and Forteo; or a prior fragility fracture (e.g., spinecompression, proximal humerus, distal radius, femoral neck/intertrochantericfracture)
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 thatprevent weight bearing as tolerated after fist post-op visit
Other contra-indication to immediate or delayed weight bearing (e.g., ipsilateralfracture effecting weight bearing status such as a calcaneus fracture); fractures ofthe 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 eitherWB 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 thatrequire 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 orhomeless at the time of injury or who are intellectually challenged without adequatefamily support)
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
University of California San Francisco Medical Center
San Francisco, California 94143
United StatesSite Not Available
University of Florida Health, Jacksonville
Jacksonville, Florida 32209
United StatesSite Not Available
Methodist Hospital
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland 21201
United StatesSite Not Available
Walter Reed National Military Medical Center
Bethesda, Maryland 20889
United StatesSite Not Available
Hennepin County Medical Center / Regions Hospita
Minneapolis, Minnesota 55415
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
Carolinas Medical Center
Charlotte, North Carolina 28204
United StatesSite Not Available
Womack Army Medical Center at Ft. Bragg
Fort Bragg, North Carolina 28100
United StatesSite Not Available
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University of Oklahoma
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15219
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
University of Texas Health Science Center - Houston
Houston, Texas 77030
United StatesSite Not Available
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas 78234
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
Inova Fairfax Hospital
Falls Church, Virginia 22042
United StatesSite Not Available
University of Washington/Harborview Medical Center
Seattle, Washington 98104
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53705
United StatesSite Not Available
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