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

NCT ID: NCT03314623

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2021-02-28

Brief Summary

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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.

Detailed Description

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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

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Surgery--Complications Tibia Fracture Early Ambulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Weight bearing as tolerated

If fracture is deemed stable the subjects will be allowed to weight bear immediately after surgery.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Slagelse Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eske Brand

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Slagelse Sygehus

Slagelse, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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59459

Identifier Type: -

Identifier Source: org_study_id

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