Clinical trial NCT03314623: Immediate Mobilization After Plate Osteosynthesis of Proximal Tibial Fractures - A Cohort Study
Official title: Immediate Mobilization After Plate Osteosynthesis of Proximal Tibial Fractures - A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Tibia Fracture
Early Ambulation
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient hospitalized at Slagelse hospital with proximal tibial fracture needing surgery with plates and screws residing in Slagelse hospital uptake area

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.

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

Primary outcomes:
measure: Loss of reduction
timeFrame: Day 0 to one year after surgery.
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Day 0 to one year after surgery.
measure: Return to Work
timeFrame: Day 0 to one year after surgery.
measure: Length of Hospital Stay
timeFrame: Day 0 to one year after surgery.
measure: Euroqol 5 Dimension (EQ-5D)
timeFrame: Day 0 to one year after surgery.
measure: The University of California at Los Angeles (UCLA) Activity Score
timeFrame: Day 0 to one year after surgery.
measure: Radiographic Osteoarthritis
timeFrame: Day 0 to one year after surgery.
measure: Status of reoperation
timeFrame: Day 0 to one year after surgery.
measure: Performance Measures
timeFrame: Day 0 to one year after surgery.
measure: Status of surgery for acute compartment syndrome
timeFrame: Day 0 to 2 weeks after
measure: Wound rupture
timeFrame: Day 0 to 6 weeks after
measure: Infection
timeFrame: Day 0 to one year after surgery.
measure: Symptomatic deep venous thrombosis (DVT)
timeFrame: Day 0 to 6 weeks after
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Slagelse Sygehus
Study officials:
References: