Clinical Trials Directory

Trials / Completed

CompletedNCT03314623

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

Status
Completed
Phase
Study type
Observational
Enrollment
70 (actual)
Sponsor
Slagelse Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWeight bearing as toleratedIf fracture is deemed stable the subjects will be allowed to weight bear immediately after surgery.

Timeline

Start date
2018-02-01
Primary completion
2021-01-31
Completion
2021-02-28
First posted
2017-10-19
Last updated
2021-03-16

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT03314623. Inclusion in this directory is not an endorsement.