A randomised controlled trial to compare the functional outcomes of two weight bearing protocols following open reduction and internal fixation of ankle fractures

St George's Healthcare NHS Trust0 个研究点目标入组 76 人开始时间: 2010年10月27日最近更新: 2016年10月17日

试验速览

暂无简介。

•1. Patients with ankle fractures admitted for an open reduction internal fixation (ORIF) by the Trauma and Orthopaedic Department at St George's Hospital and St Thomas' Hospital
•2. Radiological evidence of a fracture of the ankle requiring fixation which occurs alone (AO classification: 44-A1.2, 44-A1.3, 44-A2.1, 44-A2.2, 44-A2.3, 44.A3.1, 44-A3.2, 44-A3.3, 44-B1.1, 44-B1.2, 44-B1.3, 44.B2.1, 44-B2.2, 44-B2.3, 44-B3.1, 44-B3.2, 44-B3.3, 44-C1.1, 44-C1.2, 44-C1.3, 44.C2.1, 44-C2.2, 44-C2.3, 44-C3.1, 44-C3.2, 44-C3.3 ; Arbeitsgemeinschaft für Osteosynthesefragen/Orthopedic Trauma Association [AO/ATO] Classification, 2007)
•3. Female and male subjects greater than or equal to 18 to 70 years
•4. Body mass index (BMI) 16 - 33 kg/m^2 (minimum body weight 50 kg, maximum 140 kg)
•5. Glasgow coma score (GCS) 15
•6. Signed Informed Consent Form. The patient has to be able to give consent personally

•1. Inability to undertake assessment and treatment procedures
•2. Contralateral lower limb injury
•3. Inability to non-weight bear initially if allocated to non-weight bearing group
•4. Unstable or relative stability ORIF due to surgical difficulty and fracture configuration or poor bone stock (e.g. osteoporosis) as determined by unstable valgus/varus testing on image intensifier in theatre and post-operative notes
•5. Rupture to the syndesmosis
•6. Previous ankle fracture
•7. Anderson and Gustilo Grade II and III open fractures
•8. Fixation requiring bone grafting
•9. Active or past history of malignant tumour
•10. Evidence of systemic or localised infection at time of surgery
•11. Evidence of immunosuppression
•12. Diagnosis of diabetes mellitus (Type I or Type II)
•13. Gross osteoarthitic changes of the ankle joint (Grade 3 or above)
•14. Previous surgical intervention to the operated ankle
•15. Inability to attend out-patient physiotherapy appointments
•16. Inability to independently mobilise with or without walking aids
•17. Unwillingness to participate

发起方

St George's Healthcare NHS Trust