NCT05397327|Unknown
3D Virtual Planning for Tibial Plateau Fractures
Virtual 3D Surgical Planning for Tibial Plateau Fractures: A Multicenter Prospective Randomized Controlled Trial
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Virtual 3D Surgical Planning for Tibial Plateau Fractures: A Multicenter Prospective Randomized Controlled Trial
Sponsor study identifier
interventional
70
3 countries
3
Study Start
June 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2022
Actual (reported)May 31, 2022
Actual (reported)June 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Duration of surgery
Time in minutes from start of surgery till end of surgery
Intraoperative
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
Conventional preoperative planning using x-rays and 2D and 3D CT scan
Preoperative planning using x-rays, 2D and 3D CT scans and 3D virtual planning software
3D virtual planning software developed by Sectra AB (Linköping, Sweden)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Flinders Medical Center
Adelaide, South Australia, 5042, Australia
Job Doornberg, Professor
University Medical Center Groningen
First Submitted
May 10, 2022
First Posted
May 31, 2022
Study Start
June 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
Radboud University Medical Center
Nijmegen, Gelderland, 6525GA, Netherlands
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 31, 2022
Record last verified: 2022-05
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
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Source: ClinicalTrials.gov.
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