An observational study in Surgery--Complications, Tibia Fracture and Early Ambulation, sponsored by Slagelse Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by Slagelse Hospital · Observational
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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.
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.
135 studies on the registry are indexed under Tibial Fractures; 37 are open to participants now.
This study's enrollment of 70 is close to the median of 70 across 37 observational studies indexed under Tibial Fractures.
Browse Tibial Fractures studies →Slagelse Hospital is the lead sponsor of 21 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Every patient hospitalized at Slagelse hospital with proximal tibial fracture needing surgery with plates and screws residing in Slagelse hospital uptake area
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
If fracture is deemed stable the subjects will be allowed to weight bear immediately after surgery.
Loss of reduction
Loss of reduction/fracture collapse after ambulation measured by x ray
Time frame: Day 0 to one year after surgery.
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.
Time frame: Day 0 to one year after surgery.
Return to Work
If the subject hasnt worked prior to surgery, normal activity will be measured instead.
Time frame: Day 0 to one year after surgery.
Length of Hospital Stay
Time frame: 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.
Time frame: 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.
Time frame: Day 0 to one year after surgery.
Radiographic Osteoarthritis
Kellgren and Lawrence score
Time frame: Day 0 to one year after surgery.
Status of reoperation
Time frame: Day 0 to one year after surgery.
Performance Measures
Knee range of motion
Time frame: Day 0 to one year after surgery.
Status of surgery for acute compartment syndrome
Time frame: Day 0 to 2 weeks after
Wound rupture
Wound rupture needing suturing based on the evaluation by the investigators or a senior consultant
Time frame: Day 0 to 6 weeks after
Infection
Infection needing antibiotics, based on clinical findings combined with blodsamples measuring CRP and leucocytes.
Time frame: Day 0 to one year after surgery.
Symptomatic deep venous thrombosis (DVT)
Symptomatic DVT will be verified/disproved by ultrasound of the lower leg.
Time frame: Day 0 to 6 weeks after
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jan 2021, 35 months.
Of 17 observational studies under Tibial Fractures, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 62. This study's 35 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Slagelse Hospital