Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
NCT Number: NCT05571449
TIBIA3D is a randomized, open and prospective clinical trail that evaluates the use of preoperative 3D printing in the surgical treatment of patients with tibial plateau fractures
Looking for future studies?
Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Majadahonda, Madrid, 28222, Spain
Randomized, open and prospective study.
Once the surgical indication for osteosynthesis has been established after having suffered a tibial plateau fracture, the patients will be randomized in a 1:1 ratio to one of the tfollowing treatment groups:
Control group: images obtained by plain radiography and computed tomography are used in the planning of osteosynthesis of the tibial plateau fracture.
Experimental group: in the planning of tibial plateau fracture osteosynthesis, in addition to images obtained by plain radiography and computed tomography, a three-dimensional plastic model printed by processing the tomography images is used.
Patients (or their legal representatives) must sign the consent before randomization.
After surgery, a follow-up will be carried out at 3, 6 and 12 months, visits in which data will be collected regarding the physical examination, radiological examination, pain and questionnaires will be filled out regarding the functionality of the knee and perception of health status.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Internal fixation of the fracture
Plain radiograph and CT images are used
A 3D plastic model made from CT images is used
Time frame: Week 1
Surgical time will include the time from skin incision to wound closure
Time frame: Week 1
Intraoperative fluoroscopy time will be counted after incision and before wound closure.
Time frame: Week 1
Form filled out by the surgeon before the intervention to find out if the three-dimensional impression of the fracture has changed from the original preoperative planning that it had previously
Time frame: Week 1 - 12 months
The incidence of complications, such as superficial wound infection, deep wound infection, iatrogenic neurological symptoms, reduction loss and fixation failure, will be recorded in both groups.
Time frame: 6 weeks - 12 months
VAS measure the intensity of the pain that the patient describes. It consists of a horizontal line of 10 centimeters, with 0cm being "no pain" and 10cm being "extreme pain".
Time frame: 6 weeks - 12 months
The Knee injury and Osteoarthritis Outcome Score (KOOS) has been developed as an instrument to assess the patient's opinion about their knee and associated problems It has to separate sections ("Knee Score" and "Functional Score") that are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Time frame: 6 weeks - 12 months
Generic instrument for measuring health-related quality of life, in which the individual himself assesses his health status (0-100 score)
Time frame: 6 weeks - 12 months
It is the most widely used questionnaire to assess the results after knee and hip arthroplasty in patients with osteoarthritis in the lower extremity (0-68 score)
Looking for future studies?
Notify MePedro-José Torrijos-Garrido
Other
Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Prospective Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07481929
Fractures, Bone, Knee Fractures
Schoow, Jiangsu, China
View Trial DetailsNCT07081165
Fractures, Bone, Knee Fractures
View Trial DetailsNCT06918171
Fractures, Bone, Knee Fractures
Suzhou, Jiangsu, China
View Trial DetailsNCT03562364
Distal Femur Fracture, Distal Tibia Fracture
San Diego, California, United States
View Trial Details