crural fracture Fracture of the lower leg
Conditions
Interventions
Operation:
At the start of surgery, the surgeon will follow the treatment allocation. The
surgeon will either apply a plate to the distal fibula using a separate
incision and then proceed with tibia
Sponsors
Martini Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with a fracture distal to the isthmus of the tibial diaphysis and extending through the flare of the distal tibia, without extension to the articular surface, and an ipsilateral fibula fracture at the same level or below (AO/OTA fracture type codes 42 and 43)
Exclusion criteria
Exclusion criteria: Patient is unable to fill out long term outcome forms and/or unable to understand the English language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tibia alignment in the frontal plane (AP) will be determined by the angle between a line perpendicular to the knee joint line of the tibia and a line perpendicular to the ankle joint line. A positive value will represent varus angulation. Tibia angulation in the sagittal plane (lateral) will be defined as the angle between a line from the anterior 1/5 of the flat subchondral line of the plateaus (tibial joint line at the knee) to a proximal mid-diaphyseal point, and a line from * of the ankle joint line to a distal mid-diaphyseal point. A positive value will represent anterior angulation (procurvatum). Tibia rotation will be administered clinically with the patella forward and measuring the foot rotation with the use of a manual goniometer. Neutral position will be represented by the foot facing upwards perpendicular to the ground. A positive value represents external rotation of the foot. Malalignment will be defined as * 5 degrees deviation from 0 degrees based on the above measurements in any plane. Tibia length will also be measured clinically on both limbs. An independent observer will assess primary outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional - Knee and ankle pain (Visual Analogue Scale) - Walking distance (meters) - Knee and ankle function (SF-36 short form, Hospital for Special Surgery Knee Service Rating System, American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale) Bony healing - Healing of at least three of four cortices of the tibia on biplanar plain radiographs. (Delayed union is defined as lack of any healing on plain radiographs within 3 months, and non-union is defined as lack of progressive healing on plain radiographs over 3 months). Verification by CT scan will be used if there is difficulty in determination of union. - Extra procedures > bone grafting, > exchange intramedullary tibia nailing > hardware failure (reoperation due to hardware failure will be adjudicated as an outcome only if: 1. The patient complains of pain at the fracture sites or instability when weight bearing, and 2. Radiological evidence of hardware failure: displacement of a fracture, or breakage of the nail, bolts, screws or plate) | — |
Countries
Netherlands
Outcome results
None listed