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

Surgery--Complications Clinical Trial

— IMOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314623
• Other study ID #: 59459
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: Slagelse Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 28, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early Ambulation
• Fractures, Bone
• Surgery--Complications
• Tibia Fracture
• Tibial Fractures

Intervention

Behavioral:
• Weight bearing as tolerated
If fracture is deemed stable the subjects will be allowed to weight bear immediately after surgery.

Locations

Country	Name	City	State
Denmark	Slagelse Sygehus	Slagelse

Sponsors (1)

Lead Sponsor	Collaborator
Slagelse Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of reduction	Loss of reduction/fracture collapse after ambulation measured by x ray	Day 0 to one year after surgery.
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)	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.	Day 0 to one year after surgery.
Secondary	Return to Work	If the subject hasnt worked prior to surgery, normal activity will be measured instead.	Day 0 to one year after surgery.
Secondary	Length of Hospital Stay		Day 0 to one year after surgery.
Secondary	Euroqol 5 Dimension (EQ-5D)	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.	Day 0 to one year after surgery.
Secondary	The University of California at Los Angeles (UCLA) Activity Score	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.	Day 0 to one year after surgery.
Secondary	Radiographic Osteoarthritis	Kellgren and Lawrence score	Day 0 to one year after surgery.
Secondary	Status of reoperation		Day 0 to one year after surgery.
Secondary	Performance Measures	Knee range of motion	Day 0 to one year after surgery.
Secondary	Status of surgery for acute compartment syndrome		Day 0 to 2 weeks after
Secondary	Wound rupture	Wound rupture needing suturing based on the evaluation by the investigators or a senior consultant	Day 0 to 6 weeks after
Secondary	Infection	Infection needing antibiotics, based on clinical findings combined with blodsamples measuring CRP and leucocytes.	Day 0 to one year after surgery.
Secondary	Symptomatic deep venous thrombosis (DVT)	Symptomatic DVT will be verified/disproved by ultrasound of the lower leg.	Day 0 to 6 weeks after