A trial comparing weight bearing to non-weight bearing following ankle fracture fixatio

Not Applicable

Completed

Conditions: Closed ankle fractures
Injury, Occupational Diseases, Poisoning
Ankle fractures

Registration Number: ISRCTN33416471

Lead Sponsor: St George's Healthcare NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 76

Inclusion Criteria

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

Exclusion Criteria

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