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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05397327




Registration number
NCT05397327
Ethics application status
Date submitted
10/05/2022
Date registered
31/05/2022

Titles & IDs
Public title
3D Virtual Planning for Tibial Plateau Fractures
Scientific title
Virtual 3D Surgical Planning for Tibial Plateau Fractures: A Multicenter Prospective Randomized Controlled Trial
Secondary ID [1] 0 0
NL2022-13629
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tibial Plateau Fracture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of surgery
Timepoint [1] 0 0
Intraoperative
Secondary outcome [1] 0 0
Blood loss
Timepoint [1] 0 0
Intraoperative
Secondary outcome [2] 0 0
Surgical complications
Timepoint [2] 0 0
up to 30 days postoperative
Secondary outcome [3] 0 0
Perioperative deviations
Timepoint [3] 0 0
Immediately after x-ray or CT scan is performed
Secondary outcome [4] 0 0
Quality of reduction
Timepoint [4] 0 0
Immediately after x-ray or CT scan is performed
Secondary outcome [5] 0 0
Quality of reduction
Timepoint [5] 0 0
Immediately after x-ray or CT scan is performed
Secondary outcome [6] 0 0
Postoperative knee function
Timepoint [6] 0 0
Measured at 6 weeks, 3 months and 6 months postoperative
Secondary outcome [7] 0 0
Postoperative knee pain
Timepoint [7] 0 0
Measured at 6 weeks, 3 months and 6 months postoperative

Eligibility
Key inclusion criteria
• Adult patients of 18 years or older with a tibial plateau fracture who will receive surgical treatment for this fracture
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Center - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
Netherlands
State/province [2] 0 0
Gelderland

Funding & Sponsors
Primary sponsor type
Other
Name
Radboud University Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Massachusetts General Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Flinders Medical Center
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Job Doornberg, Professor
Address 0 0
University Medical Center Groningen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jellina Huitema, MD
Address 0 0
Country 0 0
Phone 0 0
+31243613808
Fax 0 0
Email 0 0
jellina.huitema@radboudumc.nl
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We will use the digital research environment (DRE), developed by a collaboration of hospitals in the Netherlands, to share anonymized individual participant data between the three participating centers.

Participant data that will be shared is:

* 3D Virtual planning software
* Time spent planning
* Fracture Characteristics
* Surgeon satisfaction
* Patient Demographics

* Age
* Sex
* Mechanism of injury
* Comorbidities
* BMI
* Duration of surgery
* Number of complications
* Perioperative deviations
* Quality of reduction
* Knee pain and function
* Surgeon characteristics

* Area of practice
* Sex
* Specialization
* Years in practice

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Data will become available after inclusion of the first patient. The data will be vailable until 6 months after inclusion of the last patient
Available to whom?
Only the research team will have access to the data
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://mydre.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05397327