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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture. |
|
| Control group | Other | Standard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open reduction and internal fixation | Procedure | Internal fixation of the fracture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time | Surgical time will include the time from skin incision to wound closure | Week 1 |
| Fluoroscopy time. | Intraoperative fluoroscopy time will be counted after incision and before wound closure. | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 1 |
| Complications |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 6 weeks - 12 months |
| KOOS Questionarie |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro J Torrijos Garrido, MD, PhD | Contact | +34 91 191 74 85 | pedrojose.torrijos@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Pedro J Torrijos Garrido, MD, PhD | Hospital Universitario Puerta de Hierro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro Majadahonda | Recruiting | Majadahonda | Madrid | 28222 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42129866 | Derived | Garcia Cantarero M, Torrijos Garrido PJ, de Caceres Velasco AI, Sanchez Mallo O. Efficacy of the use of 3D printing models in the treatment of tibial plateau fractures: a pilot randomized clinical trial. J Orthop Surg Res. 2026 May 13. doi: 10.1186/s13018-026-06950-w. Online ahead of print. |
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| Standard osteosynthesis planning | Procedure | Plain radiograph and CT images are used |
|
| 3-D model osteosynthesis planning | Procedure | A 3D plastic model made from CT images is used |
|
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. |
| Week 1 - 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.
| 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) | 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) | 6 weeks - 12 months |
| ID | Term |
|---|---|
| D000092463 | Tibial Plateau Fractures |
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D000092443 | Knee Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D000070799 | Open Fracture Reduction |
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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