Surgery--ComplicationsIMOPNCT03314623
Immediate Mobilization After Plate Osteosynthesis of Proximal Tibial Fractures - A Cohort Study
An observational study of Surgery--Complications and Tibia Fracture, run by Slagelse Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications, Tibia Fracture, Early Ambulation
- What is being tested?
- Weight bearing as tolerated
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient hospitalized at Slagelse hospital with proximal tibial fracture needing surgery with plates and screws residing in Slagelse hospital uptake area
Who may be able to join
- Patient hospitalized and osteosynthesized with one or several locking plates because of a proximal tibial fracture
Who cannot join
- Non-ambulatory patients,
- Patients diagnosed with dementia and
- Patients residing to another hospital
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Surgery--Complications, Tibia Fracture, Early Ambulation
- Being tested
- Weight bearing as tolerated
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight bearing as toleratedBehavioural
If fracture is deemed stable the subjects will be allowed to weight bear immediately after surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of reduction
Loss of reduction/fracture collapse after ambulation measured by x ray
Measured: Day 0 to one year after surgery.
Secondary outcomes (12)
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.
Measured: Day 0 to one year after surgery.
Return to Work
If the subject hasnt worked prior to surgery, normal activity will be measured instead.
Measured: Day 0 to one year after surgery.
Length of Hospital Stay
Measured: Day 0 to one year after surgery.
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.
Measured: Day 0 to one year after surgery.
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.
Measured: Day 0 to one year after surgery.
Radiographic Osteoarthritis
Kellgren and Lawrence score
Measured: Day 0 to one year after surgery.
Status of reoperation
Measured: Day 0 to one year after surgery.
Performance Measures
Knee range of motion
Measured: Day 0 to one year after surgery.
Status of surgery for acute compartment syndrome
Measured: Day 0 to 2 weeks after
Wound rupture
Wound rupture needing suturing based on the evaluation by the investigators or a senior consultant
Measured: Day 0 to 6 weeks after
Infection
Infection needing antibiotics, based on clinical findings combined with blodsamples measuring CRP and leucocytes.
Measured: Day 0 to one year after surgery.
Symptomatic deep venous thrombosis (DVT)
Symptomatic DVT will be verified/disproved by ultrasound of the lower leg.
Measured: Day 0 to 6 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Feb 2018
- Primary completion31 Jan 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eske Brand, Slagelse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314623
- Sponsor's protocol ID
- 59459
- Acronym
- IMOP
- Status last verified
- Mar 2021
- First submitted
- 9 Oct 2017
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Mobilization After Plate Osteosynthesis of Proximal Tibial Fractures - A Cohort Study
- ClinicalTrials.gov ID
- NCT03314623
- Acronym / sponsor ID
- IMOP / 59459
- Conditions
- Surgery--Complications, Tibia Fracture, Early Ambulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient hospitalized at Slagelse hospital with proximal tibial fracture needing surgery with plates and screws residing in Slagelse hospital uptake area
Key inclusion criteria (1 listed)
- Patient hospitalized and osteosynthesized with one or several locking plates because of a proximal tibial fracture
Key exclusion criteria (3 listed)
- Non-ambulatory patients,
- Patients diagnosed with dementia and
- Patients residing to another hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight bearing as toleratedIf fracture is deemed stable the subjects will be allowed to weight bear immediately after surgery. | Behavioural | – |
Primary outcome
Loss of reduction
Time frame: Day 0 to one year after surgery.
Loss of reduction/fracture collapse after ambulation measured by x ray
12 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Day 0 to one year after surgery.
Return to Work
Time frame: Day 0 to one year after surgery.
Length of Hospital Stay
Time frame: Day 0 to one year after surgery.
Euroqol 5 Dimension (EQ-5D)
Time frame: Day 0 to one year after surgery.
The University of California at Los Angeles (UCLA) Activity Score
Time frame: Day 0 to one year after surgery.
Radiographic Osteoarthritis
Time frame: Day 0 to one year after surgery.
Status of reoperation
Time frame: Day 0 to one year after surgery.
Performance Measures
Time frame: Day 0 to one year after surgery.
Status of surgery for acute compartment syndrome
Time frame: Day 0 to 2 weeks after
Wound rupture
Time frame: Day 0 to 6 weeks after
Infection
Time frame: Day 0 to one year after surgery.
Symptomatic deep venous thrombosis (DVT)
Time frame: Day 0 to 6 weeks after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications and Tibia Fracture, run by Slagelse Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of reduction (time frame: Day 0 to one year after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.