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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05397327
Registration number
NCT05397327
Ethics application status
Date submitted
10/05/2022
Date registered
31/05/2022
Date last updated
31/05/2022
Titles & IDs
Public title
3D Virtual Planning for Tibial Plateau Fractures
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Scientific title
Virtual 3D Surgical Planning for Tibial Plateau Fractures: A Multicenter Prospective Randomized Controlled Trial
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Secondary ID [1]
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NL2022-13629
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tibial Plateau Fracture
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 3D virtual planning software
No Intervention: Conventional planning group - Conventional preoperative planning using x-rays and 2D and 3D CT scan
Experimental: 3D virtual planning group - Preoperative planning using x-rays, 2D and 3D CT scans and 3D virtual planning software
Other interventions: 3D virtual planning software
3D virtual planning software developed by Sectra AB (Linköping, Sweden)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration of surgery
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Assessment method [1]
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Time in minutes from start of surgery till end of surgery
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Timepoint [1]
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Intraoperative
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Secondary outcome [1]
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Blood loss
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Assessment method [1]
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Amount of blood loss in milliliters during surgery
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Timepoint [1]
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Intraoperative
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Secondary outcome [2]
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Surgical complications
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Assessment method [2]
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Number of complications related to performed surgery or to condition
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Timepoint [2]
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up to 30 days postoperative
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Secondary outcome [3]
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Perioperative deviations
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Assessment method [3]
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Number of perioperative deviations of the perioperative plan
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Timepoint [3]
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Immediately after x-ray or CT scan is performed
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Secondary outcome [4]
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Quality of reduction
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Assessment method [4]
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Postoperative step off in millimeters as measured on postoperative CT scan or X-ray
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Timepoint [4]
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Immediately after x-ray or CT scan is performed
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Secondary outcome [5]
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Quality of reduction
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Assessment method [5]
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Postoperative gap in millimeters as measured on postoperative CT scan or X-ray
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Timepoint [5]
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Immediately after x-ray or CT scan is performed
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Secondary outcome [6]
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Postoperative knee function
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Assessment method [6]
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Participant indicated postoperative knee function as measured with the KOOS questionnaire (score between 0 and 100, with 100 being no pain/restrictions in knee function) and SF-36 questionnaire (score between 0 and 100, with 100 being no limitations in social functioning)
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Timepoint [6]
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Measured at 6 weeks, 3 months and 6 months postoperative
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Secondary outcome [7]
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Postoperative knee pain
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Assessment method [7]
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Participant indicated postoperative knee function as measured with the KOOS questionnaire (score between 0 and 100, with 100 being no pain/restrictions in knee function) and SF-36 questionnaire (score between 0 and 100, with 100 being no limitations in social functioning)
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Timepoint [7]
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Measured at 6 weeks, 3 months and 6 months postoperative
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Eligibility
Key inclusion criteria
• Adult patients of 18 years or older with a tibial plateau fracture who will receive
surgical treatment for this fracture
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- patients with (general) bone diseases or osseous malformation syndromes,
- ipsilateral limb fractures,
- complicated tibial plateau fractures that need an external fixator,
- previous tibial plateau fractures
- previous surgical treatment of the tibial plateau
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/06/2022
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2023
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Flinders Medical Center - Adelaide
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Recruitment postcode(s) [1]
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5042 - Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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Country [2]
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Netherlands
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State/province [2]
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Gelderland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Radboud University Medical Center
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Massachusetts General Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Flinders Medical Center
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Tibial plateau fractures are often complex fractures and need a good preoperative planning.
The investigators think that a 3D virtual planning software will help the surgeons to get a
better understanding of the fracture and therefore want to study the value of 3D virtual
planning software in the preoperative planning of tibial plateau fractures. The investigators
hypothesize that this software will shorten the duration of surgery, decrease the
peroperative bloodloss and the number of complications.
Patients with tibial plateau fractures who need surgical treatment will be asked to
participate in this study. After participants have given informed consent, they will be
randomized between a 'traditional preoperative planning' and a '3D virtual preoperative
planning' group. Surgeons will plan their surgery using traditional planning tools (X-rays
and CT scan) or traditional planning tools ánd the 3D virtual planning software.
6 weeks, 3 months and 6 months after surgery, participants will be asked to fill in 2
questionnaires about knee pain and knee function. After surgery a CT scan or X-ray will be
performed conform standard of care in the hospital.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05397327
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Job Doornberg, Professor
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Address
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University Medical Center Groningen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jellina Huitema, MD
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Address
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Country
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Phone
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+31243613808
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05397327
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