| Registry | NCT03314623, acronym IMOP |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 70 (Actual) |
| Sponsor | Slagelse Hospital (Other) |
| Conditions | Surgery--Complications, Tibia Fracture, Early Ambulation |
| Interventions | Weight bearing as tolerated (Behavioral) |
| Dates | start 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 in Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Surgery--Complications All trials for Tibia Fracture All trials of Weight bearing as tolerated
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.
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Slagelse Sygehus | Slagelse | Denmark |