None listed
Conditions
Brief summary
This is a multicentre randomised controlled trial involving 154 patients with ankle fractures requiring surgical fixation. Participants will be randomly allocated to one of two groups: one group will start walking within a day after surgery and the other group will wait for 6 weeks before they start walking. We will compare the outcome of two interventions in terms of functional ability, quality of life, time to return to work, time to return to pre-injury activities and post-operative complications. This study will determine whether Immediate weight bearing leads to superior clinical outcomes and is as safe as delayed weight bearing.
Interventions
Immediate Weight Bearing (IWB) group:
Eligible patients with displaced ankle fractures treated with open reduction and internal fixation will be randomised to the immediate weight bearing group post-operatively. Patients will have their ankle immobilised in a Moonboot for 6 weeks and will not be permitted to remove the moonboot for ankle range of motion exercises during this period. Patients will be instructed to commence weight bearing from day one post-operatively. The level of weight bearing
Immediate Weight Bearing (IWB) group: Eligible patients with displaced ankle fractures treated with open reduction and internal fixation will be randomised to the immediate weight bearing group post-operatively. Patients will have their ankle immobilised in a Moonboot for 6 weeks and will not be permitted to remove the moonboot for ankle range of motion exercises during this period. Patients will be instructed to commence weight bearing from day one post-operatively. The level of weight bearing will be determined by the patient's pain tolerance and physical fitness. Walking aids will be provided by the treatment medical team (including doctors, nurses, physiotherapists, and occupational therapists). Patients will be encouraged to progressively increase their weight bearing and transition to independent walking without aids as tolerated. Adherence to the intervention will be assessed through a combination of strategies: 1) Participant self-report during follow-up assessments, 2) Trial manager check-ins (e.g., during safety checks), where participants can raise concerns or report deviations. Any deviation from the prescribed weight bearing protocol will be documented in the follow-up completion form.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with unilateral closed ankle fractures treated with open reduction internal fixation will be included. Eligible fracture pattern will be Isolated malleolar fracture (including medial, lateral, or posterior malleolus fractures), bimalleolar and trimalleolar fractures. Patients treated with an external fixator before ORIF remain eligible. These fracture patterns will be eligible if post-operative stability is confirmed by operating surgeons. Patients must have been ambulatory with or without walking aids before injury.
Exclusion criteria
Key exclusion criteria 1) Fractures with questionable stability after fixation as determined by the surgeon. 2) Pilon fractures, 3) patients require syndesmotic fixation 4) patients with concurrent injuries preventing protocol adherence 5) Pathological fracture 6) Compound fracture 7) Patients with neurological disorders (e.g., severe cognitive impairment, substance abuse, intellectual disability). 8) Patients with dense peripheral neuropathy. 9) Patients with significant additional physical impairments (e.g., polytrauma patients).
Outcome results
None listed