Summary

for people ages 18-65 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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.

Details

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 to 65 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 18-65 surgically treated with a unicondylar plateau fracture without joint impaction. The figure below provides an overview of the study timeline and procedures.

Keywords

Rehabilitation Early Weight Bearing Delayed Weight Bearing

Eligibility

You can join if…

Open to people ages 18-65

  1. Adults ages 18-65 inclusive
  2. Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria:
  3. vertical shear medial malleolus with lateral malleolar fracture
  4. bimalleolar fracture requiring medial and lateral fixation
  5. trimalleolar fracture with or without posterior malleolar fixation
  6. Ankle dislocations that are definitively fixed
  7. Operative treatment of an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.

You CAN'T join if...

  1. Gustilo Type III injuries or soft tissue injury of either lower extremity that would contra-indicate immediate or delayed WB
  2. Syndesmotic injuries/fixation
  3. 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)
  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 that prevent weight bearing as tolerated after fist post-op visit
  7. 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)
  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 either WB 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 that require 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 or homeless at the time of injury or who are intellectually challenged without adequate family support)

Locations

  • University of California San Francisco Medical Center
    San Francisco California 94143 United States
  • Womack Army Medical Center at Ft. Bragg
    Fort Bragg North Carolina 28100 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Major Extremity Trauma Research Consortium
ID
NCT04028414
Study Type
Interventional
Last Updated