Compound fractures of tibia
Conditions
Interventions
1. Study site- Orthopedic wards of the North Colombo Teaching Hospital and National Hospital of Sri Lanka
2. Intervention- The MK03 external fixator will be the new device used. When a patient is admi
Sponsors
Imperial College London
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years and above 2. Patients who present with compound fractures of the tibia
Exclusion criteria
Exclusion criteria: 1. Patients who present more than 1 week after injury 2. Patients whose fracture pattern requires a joint spanning external fixation 3. Patients who are unable to consent 4. Patients who are immunocompromised or with conditions which delay wound healing.(E.g malignancy, liver, renal disease, on steroids etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pin site infection will be graded based on the severity scale for pin site infection – Checketts-Otterburn classification [2,4,6,8 and 12 weeks] Pin loosening – This is a clinical assessment which has a binary, ‘Yes’ or ‘No’ value [ 2,4,6,8 and 12 weeks] Stability of the construct - This is a clinical assessment which has a binary, ‘Yes’ or ‘No’ value [ 2,4,6,8 and 12 weeks] Progression of soft tissue healing – Based on the final treatment – a. Primary closure achieved b. Delayed primary closure achieved c. Closure with skin graft d. Local tissue transfer e. Free tissue transfer f. Amputation [ 2,4,6,8 and 12 weeks] [] [] [] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] | — |
Secondary
| Measure | Time frame |
|---|---|
| Evidence of deformed clamp sites:Visual inspection using pre and post images. The image will be taken in the Orthogonal view to the clamp axis for this purpose. Binary scale (“Yes”/”No”) will be used to measure the outcome [2,4,6,8 and 12 weeks] Evidence of damage to any fixator, measured by visual inspection using pre and post images. The image will be taken in the Orthogonal view to the clamp axis for this purpose. Binary scale (“Yes”/”No”) will be used to measure the outcome [ 2,4,6,8 and 12 weeks] Extent of fixator slippage between interfaces:Measured by orthogonal x rays taken immediately post op and during follow up will be used. By comparing orthogonal x ray, with the previous x ray, any change in position of the screws, clamps and rods, in axial, sagittal and coronal planes can be compared. This will be an indicator of evidence of fixator slippage [ 2,4,6,8 and 12 weeks] Extent of deformed rods, measured using visual inspection using pre and post images. [ 2,4,6,8 and 12 weeks] Evidence of any surface damage in the composite connecting rod at the clamping locations:Measured by visual inspection using pre and post images [ 2,4,6,8 and 12 weeks] [] [] [ ] [ ] [ ] [] [] [] [] [] [ ] [ ] [] [] [] [] [] [] [] [] [ ] [] [ ] [] [] [] [] [ ] [] [] [] [ ] [] [] [] [] [] [] [ ] [] [] [ ] [] [] [] [ ] [] [ ] [] [] [] [] [] [] [ ] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [ ] [] [] [] [] [] [ ] [] [] [] [] [] [] [] [] [] [] [ ] [] [ ] [] [] [] [] [] [] [] [] [] [ ] [ ] [] [ ] [ ] [] [] [] [] [] [] [] [] [] [] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Pujitha Silva
Senior Lecturer
Outcome results
None listed