Immediate Mobilization After Plate Osteosynthesis of Proximal Tibial Fractures - A Cohort Study
- Conditions
- Early AmbulationTibia FractureSurgery--Complications
- Registration Number
- NCT03314623
- Lead Sponsor
- Slagelse Hospital
- Brief Summary
The purpose of this study is to investigate if immediate mobilization with weight bearing as tolerated following surgery with plates and screws after a fracture of the shinbone near the knee is possible without increased risk.
The investigators hypothesize immediate weight bearing as tolerated following surgery with plates and screws of the above mentioned fracture, in cases deemed stable by the surgeon, will not lead to any loss of reduction.
- Detailed Description
The purpose of this study is to investigate immediate mobilization with weight bearing as tolerated following plate osteosynthesis after a proximal tibial plateau fracture is possible without increased risk of loss of reduction and/or failure of the osteosynthesis. Subsequently, this may lead to earlier recovery and less risk of thromboembolic complications.
The investigators hypothesize immediate weight bearing as tolerated (WBAT) following plate osteosynthesis after a proximal tibial plateau fracture, in cases deemed stable by the surgeon, will not lead to any loss of reduction.
Exposure will be defined as surgery with one or two angular stable plates (closed reduction, internal fixation) after a proximal tibial fracture. Patients will be allowed immediate weight bearing as tolerated in cases where the osteosynthesis is deemed stable. This represents the current practice at Slagelse Hospital. Typical, all lateral tibia plateau fractures (AO fracture classification 41B1-3) osteosynthesized will be allowed immediate WBAT after surgery. Other tibia plateau fractures will be allowed immediate WBAT if the osteosynthesis is deemed stable by the surgeon perioperatively.
Fractures are treated with one or several locking plates, and if needed after reduction of the tibial plateau, an impacted allogenic bone graft is used. The bone graft is applied through a cortical window osteotomy distal to the fracture.
Follow up will be performed at 2 weeks, 6 weeks, 3 months, 6 months and 1 year by any of the authors or a consultant in orthopedics. Follow up will be performed at the outpatient clinic.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Patient hospitalized and osteosynthesized with one or several locking plates because of a proximal tibial fracture
- Non-ambulatory patients,
- Patients diagnosed with dementia and
- Patients residing to another hospital
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Loss of reduction Day 0 to one year after surgery. Loss of reduction/fracture collapse after ambulation measured by x ray
- Secondary Outcome Measures
Name Time Method Status of reoperation Day 0 to one year after surgery. Knee injury and Osteoarthritis Outcome Score (KOOS) Day 0 to one year after surgery. KOOS is a self-reported questionnaire comprising five subscales: pain, other symptoms, activities in daily living (ADL), function in sport and recreation and knee-related quality of life (QOL). The previous week is taken into consideration when patients are answering the questions. Standardized answer options are given (5 boxes on a Likert scale) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Performance Measures Day 0 to one year after surgery. Knee range of motion
Wound rupture Day 0 to 6 weeks after Wound rupture needing suturing based on the evaluation by the investigators or a senior consultant
The University of California at Los Angeles (UCLA) Activity Score Day 0 to one year after surgery. A Danish version of the UCLA activity score will be used to assess the activity level before and after they have undergone surgery. The patients will answer the questionnaire preoperative and at the appointments in the outpatient clinic. The UCLA activity score ranges from 1-10 (not active-highly active) and the patient has to choose one out of the ten options based on their activity level for the past four weeks.
Symptomatic deep venous thrombosis (DVT) Day 0 to 6 weeks after Symptomatic DVT will be verified/disproved by ultrasound of the lower leg.
Length of Hospital Stay Day 0 to one year after surgery. Return to Work Day 0 to one year after surgery. If the subject hasnt worked prior to surgery, normal activity will be measured instead.
Euroqol 5 Dimension (EQ-5D) Day 0 to one year after surgery. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Radiographic Osteoarthritis Day 0 to one year after surgery. Kellgren and Lawrence score
Status of surgery for acute compartment syndrome Day 0 to 2 weeks after Infection Day 0 to one year after surgery. Infection needing antibiotics, based on clinical findings combined with blodsamples measuring CRP and leucocytes.
Trial Locations
- Locations (1)
Slagelse Sygehus
🇩🇰Slagelse, Denmark