3D Virtual Planning for Tibial Plateau Fractures
Virtual 3D Surgical Planning for Tibial Plateau Fractures: A Multicenter Prospective Randomized Controlled Trial
1 other identifier
interventional
70
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 31, 2022
May 1, 2022
1 year
May 10, 2022
May 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of surgery
Time in minutes from start of surgery till end of surgery
Intraoperative
Secondary Outcomes (7)
Blood loss
Intraoperative
Surgical complications
up to 30 days postoperative
Perioperative deviations
Immediately after x-ray or CT scan is performed
Quality of reduction
Immediately after x-ray or CT scan is performed
Quality of reduction
Immediately after x-ray or CT scan is performed
- +2 more secondary outcomes
Study Arms (2)
Conventional planning group
NO INTERVENTIONConventional preoperative planning using x-rays and 2D and 3D CT scan
3D virtual planning group
EXPERIMENTALPreoperative planning using x-rays, 2D and 3D CT scans and 3D virtual planning software
Interventions
3D virtual planning software developed by Sectra AB (Linköping, Sweden)
Eligibility Criteria
You may qualify if:
- Adult patients of 18 years or older with a tibial plateau fracture who will receive surgical treatment for this fracture
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Massachusetts General Hospitalcollaborator
- Flinders Medical Centercollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Flinders Medical Center
Adelaide, South Australia, 5042, Australia
Radboud University Medical Center
Nijmegen, Gelderland, 6525GA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Job Doornberg, Professor
University Medical Center Groningen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2022
First Posted
May 31, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2023
Study Completion
December 1, 2023
Last Updated
May 31, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will become available after inclusion of the first patient. The data will be vailable until 6 months after inclusion of the last patient
- Access Criteria
- Only the research team will have access to the data
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