Immediate Mobilization After Plate Osteosynthesis of Proximal Tibial Fractures - A Cohort Study

Study Overview
=================
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.

Official Title
-----------------
Immediate Mobilization After Plate Osteosynthesis of Proximal Tibial Fractures - A Cohort Study

Conditions
-----------------
Surgery--Complications, Tibia Fracture, Early Ambulation

Intervention / Treatment
-----------------
* Behavioral: Weight bearing as tolerated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient hospitalized and osteosynthesized with one or several locking plates because of a proximal tibial fracture Exclusion Criteria: Non-ambulatory patients, Patients diagnosed with dementia and Patients residing to another hospital

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Weight bearing as tolerated|If fracture is deemed stable the subjects will be allowed to weight bear immediately after surgery.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of reduction | Loss of reduction/fracture collapse after ambulation measured by x ray | Day 0 to one year after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | 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. | Day 0 to one year after surgery. | 
| Return to Work | If the subject hasnt worked prior to surgery, normal activity will be measured instead. | Day 0 to one year after surgery. | 
| Length of Hospital Stay |  | Day 0 to one year after surgery. | 
| Euroqol 5 Dimension (EQ-5D) | 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. | Day 0 to one year after surgery. | 
| The University of California at Los Angeles (UCLA) Activity Score | 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. | Day 0 to one year after surgery. | 
| Radiographic Osteoarthritis | Kellgren and Lawrence score | Day 0 to one year after surgery. | 
| Status of reoperation |  | Day 0 to one year after surgery. | 
| Performance Measures | Knee range of motion | Day 0 to one year after surgery. | 
| Status of surgery for acute compartment syndrome |  | Day 0 to 2 weeks after | 
| Wound rupture | Wound rupture needing suturing based on the evaluation by the investigators or a senior consultant | Day 0 to 6 weeks after | 
| Infection | Infection needing antibiotics, based on clinical findings combined with blodsamples measuring CRP and leucocytes. | Day 0 to one year after surgery. | 
| Symptomatic deep venous thrombosis (DVT) | Symptomatic DVT will be verified/disproved by ultrasound of the lower leg. | Day 0 to 6 weeks after |