Distal tibia fracture AO classification 43 type A1,A2,A3 and C1.
Conditions
Interventions
None listed
Sponsors
Okayama University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.primary distal tibia fracture patient (AO43 type A1, A2, A3 and C1). 2.Japanese people. 3.Age is over 18. 4.Patient who agree with this reserach by themselves or legal representative. 5.Patient who can visit hospital as plan. 6.Patient who can walk by themselves before fracture.
Exclusion criteria
Exclusion criteria: 1.defromity of distal tibia 2.pathological fracture 3.allergy for metal 4.pregnant patient 5.two week past from injury 6.growth plate can be seen with X-ray photo 7.abuse of alchol or drug 8.patient who is judged as unqualified by reseracher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy : bone union rate at 6 months after surgery, median of bone union duration. Safety : rate of adverse effect related to surgery(soft tissue injury, surgery procedure). | — |
Secondary
| Measure | Time frame |
|---|---|
| All item below are assessed at surgery and 6, 12, 24, 52 week after surgery. Clinical efficecy including QOL score : EQ-ED-5L Japanese edition, Self-Administered Foot Evaluation Questionnaire(SAFE-Q), AOFAS(The American Orthopedic Foot and Ankle Score) Radiographical assessment : valgus and varus/anteversion and retroversion, rate of reduction loss/displacement. Rate of adverse effect related to implant. Visual analogue scale (VAS). Surgery related assessment : operation time, X-ray exposure time. | — |
Countries
Japan
Contacts
Public ContactYasuaki Yamakawa
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical science. Department of Community Medicine
Outcome results
None listed