Tibial Plateau Fracture
Conditions
Keywords
3D printing, Tibial fracture
Brief summary
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
Detailed description
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.
Interventions
PROCEDUREOpen reduction and internal fixation
Internal fixation of the fracture
PROCEDUREStandard osteosynthesis planning
Plain radiograph and CT images are used
PROCEDURE3-D model osteosynthesis planning
A 3D plastic model made from CT images is used
Sponsors
Pedro-José Torrijos-Garrido
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with tibial plateau fracture requiring surgical treatment. * Age equal to or greater than 18 years. * Signature of informed consent in writing according to current legislation before collecting any information.
Exclusion criteria
* Pregnancy in progress. * Presence of serious systemic pathology or another situation that contraindicates treatment * Presence of other fractures in the ipsilateral femur or tibia that condition the surgical treatment of the tibial plateau fracture. * Findings in the physical examination, in the results of the tests or other medical, social or psychopathological factors that, in the opinion of the investigators, could negatively influence the study. * Inability to grant informed consent in the absence of a legal representative. * Inability to follow instructions or collaborate during the development of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical time | Week 1 | Surgical time will include the time from skin incision to wound closure |
| Fluoroscopy time. | Week 1 | Intraoperative fluoroscopy time will be counted after incision and before wound closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of surgical planning with 3d printing | 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 |
| Complications | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogis Scale for Pain | 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. |
| KOOS Questionarie | 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. |
| EuroQol-5D Questionarie | 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) |
| WOMAC Questionarie | 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) |
Countries
Spain
Contacts
Primary ContactPedro J Torrijos Garrido, MD, PhD
Outcome results
None listed