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3D Virtual Planning for Tibial Plateau Fractures

NCT05397327 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-05-31

No results posted yet for this study

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.

Conditions

  • Tibial Plateau Fracture

Interventions

OTHER

3D virtual planning software

3D virtual planning software developed by Sectra AB (Linköping, Sweden)

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Flinders Medical Center

    collaborator UNKNOWN

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Job Doornberg, Professor · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • United States
  • Australia
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397327 on ClinicalTrials.gov