Authors
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Hing, Caroline -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2010
INTERVENTION: Both the delayed and early weight bearing groups will have a backslab applied at the time of surgery. At 2 weeks this will be converted to a full non weight bearing cast in the delayed weight bearing group and an aircast boot (full weight bearing) in the early weight bearing group. At 6 weeks both groups will be allowed to fully bear weight free of cast or boot. CONDITION: Closed ankle fractures ; Injury, Occupational Diseases, Poisoning ; Ankle fractures PRIMARY OUTCOME: Olerud and Molander Subjective Ankle Score: This was chosen as the primary outcome measure since our research question asks that we assess patient's function primarily, which this outcome measure satisfies. Furthermore, previous authors have used this outcome measure in their investigations on ankle fracture management, and therefore, by using this outcome measure, we would be able to compare our findings to their results. Finally, although the reliability and validity of this tool has not been formally assessed for ankle fracture populations, the literature suggests that such a procedure has not been assessed with any outcome measure, and due to the other two factors, it was deemed that this would be the most appropriate outcome measure. Measured at 6 weeks, 3 months, 6 months, 1 year. SECONDARY OUTCOME: 1. EQ‐5D, assessed in the clinic setting. Although this measure is frequently assessed as a postal questionnaire, it will be assessed in the clinic to increase the response rate. Measured at 6 weeks, 3 months, 1 year; range of motion at 6 weeks; 2. Range of ankle plantar flexion and dorsiflexion of both the injured and un‐injured ankle. This will be assessed using goniometry and the bony landmarks of the head of the fifth metatarsal, and the fibula head; 3. Patient reported outcome measures will also be a requirement within the UK National Health Service; 4. Any post‐operative complications such as infection, mal‐union, implant loosening or breakage, deep vein thrombosis (DVT), measured at 6 weeks; 5. Total time lost from work by asking each patient how long they required off work if applicable; 6. Duration of in‐patient hospital stay by reviewing the medical notes; 7. Duration of physiotherapy rehabilitation by reviewing the physiotherapy notes, assessed at one year; 8. Finally anatomical reduction and time to fracture union, assessed by an orthopaedic surgeon using clinical and radiographic examination. The latter assessment will be determined by satisfying the following criteria:; 8.1. No bony tenderness on palpation around the fracture site; 8.2. Pain‐free weight bearing (determined as when the patient can stand solely on the injured leg reportedly pain‐free for a total of 10 seconds); 8.3. Bridging callus on at least two cortices (orthogonal) on plain radiographs; Measured at 2 weeks 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
Epistemonikos ID: f1fbd283e2021f16b7d18314ca6f1d1512f98f20
First added on: Aug 22, 2024