Closed tibial fractures Infections and Infestations Closed tibial fracture
Conditions
Interventions
The trial is a before and after study design with 40 patients in total (20 in each arm). The first 20 receive treatment as usual, which consists of plaster of Paris with or without traction and a tota
Sponsors
The College of Medicine and Allied Health Sciences (COMAHS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Able to provide written informed consent 3. Diagnosis of a closed diaphyseal tibial fracture with no intraarticular extension, and amenable to limb-sparing surgery following radiographic investigation 4. Fractures must have an angular deformity of 10 degrees or greater, or a displacement of greater than 50% in any plane at entry into the trial 5. Fracture sustained within 3 weeks of eligibility assessment 6. American Society of Anaesthesiologists (ASA) physical status =3 7. Capable of completing required questionnaires at time of consent
Exclusion criteria
Exclusion criteria: 1. Open fractures 2. Undisplaced fractures 3. Concurrent fractures of any bone requiring operative or traction management (concurrent fracture of the ipsilateral fibular is permitted) 4. Pre-existing diabetes via finger prick capillary blood glucose check 5. Pre-existing neuropathy via clinical examination of a doctor 6. Pre-operative compartment syndrome via clinical examination of a doctor 7. Sickle cell disease by past medical history 8. Immunosuppression by past medical history 9. Pathological fractures by radiographic and clinical examination 10. Lower limb lymphatic filariasis by clinical examination 11. Any previous involvement in the before or after arm of the trial 12. Patients who reside outside of the Western region catchment area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The fracture angular deformity at 3 months post-management, as defined by overall angular deformity on long leg alignment views via anteroposterior and lateral plain radiographs | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed after 30 and at 3 months post-management: 1. Length of hospital stay, defined as the time between registration into trial and actual discharge date or censored at end of trial follow-up 2. Date of being medically fit for discharge, defined as the time between entry into the trial and clinical assessment concluding the patient is medically fit for discharge or censored at end of trial follow-up 3. Time to fully weight bear, defined as the ability to mobilise unaided based on clinical evaluation by a member of the caring team 4. Time to patient rerun to work or pre-morbid responsibilities (e.g. caregiving) if not employed and is self-defined by patient 5. Patient self-reported functional status, assessed using the Lower Limb Functional Index (LLFI) 6. Quality of life, assessed using the EuroQol-5D (EQ5D) | — |
Countries
Sierra Leone
Outcome results
None listed