An interventional study of Open reduction and internal fixation and Standard osteosynthesis planning in Tibial Plateau Fracture, sponsored by Pedro-José Torrijos-Garrido. Completed at 1 site in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Pedro-José Torrijos-Garrido · Not applicable, Interventional, and Treatment
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
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.
32 studies on the registry are indexed under Tibial Plateau Fractures; 9 are open to participants now.
This study's enrollment of 35 is below the median of 44 across 20 interventional studies indexed under Tibial Plateau Fractures.
Browse Tibial Plateau Fractures studies →Pedro-José Torrijos-Garrido is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture.
Procedure: Open reduction and internal fixation · Procedure: Standard osteosynthesis planning · Procedure: 3-D model osteosynthesis planning
Standard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging).
Procedure: Open reduction and internal fixation · Procedure: Standard osteosynthesis planning
Internal fixation of the fracture
Plain radiograph and CT images are used
A 3D plastic model made from CT images is used
Surgical time
Surgical time will include the time from skin incision to wound closure
Time frame: Week 1
Fluoroscopy time.
Intraoperative fluoroscopy time will be counted after incision and before wound closure.
Time frame: Week 1
Ease of surgical planning with 3d printing
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
Complications
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: Week 1 - 12 months
Visual Analogis Scale for Pain
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
KOOS Questionarie
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
EuroQol-5D Questionarie
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
WOMAC Questionarie
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)
Time frame: 6 weeks - 12 months
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pedro-José Torrijos-Garrido