Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and T… (NCT04028414) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures
United States450 participantsStarted 2020-01-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
Number of Study Related Complications Experienced
Timeframe: 12 months
2
Return to Usual Major Activity and Work Productivity
✕. 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)