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

Last updated: January 21, 2025
Sponsor: Major Extremity Trauma Research Consortium
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Early Weight Bearing

Clinical Study ID

NCT04028414
W81XWH-18-1-0810
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults ages 18 or older

  2. Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meetingone of the following criteria:

  3. bimalleolar fracture requiring fixation of any two malleoli (i.e.lateral/medial, medial/posterior, lateral/posterior)

  4. bimalleolar equivalent SER4 fractures (lateral malleolus fracture requiringfixation and no medial or posterior malleolus fixation)

  5. trimalleolar fracture with fixation of at least two malleoli (i.e.lateral/medial, medial/posterior, lateral/posterior)

  6. Operative treatment of an isolated lower extremity unicondylar tibial plateaufracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.

Exclusion

Exclusion Criteria:

  1. Gustilo Type III injuries or soft tissue injury of either lower extremity that wouldcontra-indicate immediate or delayed WB

  2. Syndesmotic injuries/fixation

  3. 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)

  4. Neuropathy, defined as diagnosis of peripheral neuropathy in medical record,neuropathic foot ulcer, or diminished or absent plantar sensation to light touch.

  5. Pathologic fracture related to neoplasm

  6. Fractures and dislocations to the ipsilateral or contralateral lower limb thatprevent weight bearing as tolerated after fist post-op visit

  7. 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)

  8. Any upper limb injury that would limit upper extremity weight bearing (e.g.,surgical neck fracture of proximal humerus)

  9. 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)

  10. Patient has third degree burns on >10% total surface area affecting the study limb

  11. Tibial plateau fractures that are required to wear a locking brace or fractures thatrequire fixed immobilization beyond four weeks (e.g., cast)

  12. Non-ambulatory pre-injury

  13. Pre-injury limitation to ROM of ipsilateral hip, knee or ankle

  14. Morbidly obese (BMI ≥40)

  15. Documented psychiatric disorder requiring admission in perioperative period

  16. 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

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: Early Weight Bearing
Phase:
Study Start date:
January 01, 2020
Estimated Completion Date:
March 31, 2025

Study 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 will enroll patients ages 18 or older surgically treated for an ankle fracture or fracture dislocation (without syndesmosis) at participating civilian trauma centers and military treatment facilities. Eligible patients will be identified during hospitalization for definitive treatment and enrolled prior to discharge or at the first post op clinic visit. Patients that consent to participate will complete a baseline assessment at the first post op clinic visit and will be randomized to early versus delayed weight bearing. Both treatment groups will receive standardized exercises that can be done at home or with a therapist. Outcomes will be evaluated at 6 weeks, 3, 6 and 12 months following definitive fracture fixation. All 6 week, 3 and 6 month evaluations will take place in the surgeon's outpatient clinic and involve clinical and radiographic assessments of healing as well as functional outcome surveys. The 12 month evaluation will be conducted by phone except for individuals who were judged not to be healed (clinically or radiographically) at 6 months; these participants will be asked to return for their 12 month evaluation (to assess healing). Simultaneously, a pilot RCT will be conducted in patients 18 or older surgically treated with a unicondylar plateau fracture without joint impaction.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of California San Francisco Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • University of Florida Health, Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Methodist Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Maryland R Adams Cowley Shock Trauma Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20889
    United States

    Site Not Available

  • Hennepin County Medical Center / Regions Hospita

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Womack Army Medical Center at Ft. Bragg

    Fort Bragg, North Carolina 28100
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15219
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas Health Science Center - Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • San Antonio Military Medical Center (SAMMC)

    San Antonio, Texas 78234
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • University of Washington/Harborview Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Site Not Available

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