Health Condition 1: null- Infection
Conditions
Interventions
None listed
Sponsors
AO Clinical Investigation and Documentation
Eligibility
Inclusion criteria
Inclusion criteria: 1) Men and women who are 18 years of age or older. 2) Open or closed tibia fracture treated by internal fixation (plate or nail). 3) Ability to understand the content of the subject information / informed consent form and to be willing to participate in the clinical investigation. 4) Written informed consent. 5) Subjects with bilateral fractures will be included. In these subjects, the most severe fracture will be the one included in the study.
Exclusion criteria
Exclusion criteria: 1) Subjects with fractures older than 14 days at the time of enrollment. 2) Previous wound infection or osteomyelitis at the same limb (according to subject history). 3) External fixation (before internal fixation or as main intervention). 4) Previous fracture with retained hardware in injured extremity that will interfere with implant fixation. 5) Immunological deficiency disease. 6) Tumor related fractures. 7) Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5). 8) Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment. 9) Subject is a prisoner. 10) Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of tibia fracture patients with infection and Distribution of infection based on time from surgery (early, delayed, late) and location (superficial or deep)Timepoint: 1 year after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Influencing Factors (hospital standard hygienic and antibiotic protocol, subject demographics, time between injury and surgery and between admission and surgery, fracture type based on AO Müller classification, soft tissue damage according to the Tscherne classification for closed fractures and the Gustilo classification for open fractures, fracture management and implant type, duration of surgery)Timepoint: within 1 year after surgery;Complication Rate in patients with and without infectionTimepoint: within 1 year after surgery.;Health-Related Quality of Life Measured by EurolQol-5 Dimensions (EQ-5D) in patients with and without infectionTimepoint: within 1 year after surgery. ;Infection ManagementTimepoint: within 1 year after surgery.;Treatment OutcomeTimepoint: within 1 year after surgery. | — |
Countries
India
Contacts
Public ContactDr Prakash Doshi
Dr Balabhai Nanavati Hospital Mumbai
Outcome results
None listed