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Completed

NCT Number: NCT03314623

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

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.

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Key information

Conditions

Surgery--Complications Early Ambulation Fractures, Bone Leg Injuries Tibia Fracture Tibial Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Slagelse Sygehus

Slagelse, 4200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight bearing as tolerated

Behavioral

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

Primary outcomes

  1. Loss of reduction

    Time frame: Day 0 to one year after surgery.

    Loss of reduction/fracture collapse after ambulation measured by x ray

Secondary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Day 0 to one year after surgery.

    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.

  2. Return to Work

    Time frame: Day 0 to one year after surgery.

    If the subject hasnt worked prior to surgery, normal activity will be measured instead.

  3. Length of Hospital Stay

    Time frame: Day 0 to one year after surgery.

  4. Euroqol 5 Dimension (EQ-5D)

    Time frame: Day 0 to one year after surgery.

    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.

  5. The University of California at Los Angeles (UCLA) Activity Score

    Time frame: Day 0 to one year after surgery.

    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.

  6. Radiographic Osteoarthritis

    Time frame: Day 0 to one year after surgery.

    Kellgren and Lawrence score

  7. Status of reoperation

    Time frame: Day 0 to one year after surgery.

  8. Performance Measures

    Time frame: Day 0 to one year after surgery.

    Knee range of motion

  9. Status of surgery for acute compartment syndrome

    Time frame: Day 0 to 2 weeks after

  10. Wound rupture

    Time frame: Day 0 to 6 weeks after

    Wound rupture needing suturing based on the evaluation by the investigators or a senior consultant

  11. Infection

    Time frame: Day 0 to one year after surgery.

    Infection needing antibiotics, based on clinical findings combined with blodsamples measuring CRP and leucocytes.

  12. Symptomatic deep venous thrombosis (DVT)

    Time frame: Day 0 to 6 weeks after

    Symptomatic DVT will be verified/disproved by ultrasound of the lower leg.

Sponsors and collaborators

Lead sponsor

Slagelse Hospital

Other

Registry information

Acronym: IMOP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2017
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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