None listed
Conditions
Brief summary
Our team at Christchurch Hospital conducted a pilot study to explore whether a larger study comparing immediate weight bearing versus delayed weight bearing after ankle fractures is feasible and safe. The study ran for one and a half years. 32 participants took part and were randomly assigned to either immediate weight bearing (IWB) (16 participants) or delayed weight bearing (DWB) (16 participants). All participants were in a Moonboot for 6 weeks and were monitored for function, pain, quality of life, and return to normal activities at 6 weeks, 3 months, and 6 months after surgery. Participants in the immediate weight bearing group started putting weight on the ankle as tolerable from day one after surgery. Participants in delayed weight bearing did not put weight on the ankle until 6 weeks after their surgery. What we learned: • 71% of eligible patients agreed to participate in our study. • We could enrol 2-3 participants per month. • Both groups demonstrated good functional outcomes and reduced pain, with improvements observed at each follow-up time point. • On average, participants in the IWB group returned to full weight bearing at 33 days, compared with 66 days in the DWB group • On average, patients in the IWB group whose work involved manual labour returned to work at 57 days compared with 112 days in the DWB group, while sedentary workers showed no difference between the groups. • Two participants in the IWB group experienced complications one minor and one requiring additional surgery. No complications occurred in the delayed weight bearing group. • Two participants withdrew after randomisation (one from each group). Challenges we faced: • Some surgeons preferred delayed weight bearing, which slowed the recruitment process in the early months of the study. • Surgeons excluded participants with high Body mass index and those with osteoporosis, which were exclusions outside of the study parameters. • We encountered difficulties collecting data in person. Improvements for the larger trial: • We will introduce clearer communication and training for surgeons to ensure consistency in the procedures performed. • We will include orthopaedic trainees to help with screening and communication. • Where possible we will use online follow-up questionnaires to make participation easier
Interventions
Immediate Weight Bearing (IWB) group:
Patients will receive pre-operative x-rays and CT scans as required. They will be treated by orthopaedic registrars, fellows or consultants according to their preferred techniques. After surgery, all included patients will be placed in a moonboot. They will be instructed to keep their moonboots on at all times, and to keep their wounds dry.
Patients in the IWB group will be encouraged to fully weight bear within 24 hours which means they should stand or w
Immediate Weight Bearing (IWB) group: Patients will receive pre-operative x-rays and CT scans as required. They will be treated by orthopaedic registrars, fellows or consultants according to their preferred techniques. After surgery, all included patients will be placed in a moonboot. They will be instructed to keep their moonboots on at all times, and to keep their wounds dry. Patients in the IWB group will be encouraged to fully weight bear within 24 hours which means they should stand or walk without using walking aids. It is envisaged that patients in the IWB group will self-limit the amount of weight they put through their ankle based on their pain tolerance and physical fitness. If necessary, walking aids (crutches, walking frames etc.) will be provided as determined by the treating doctors, nurses, physiotherapists and occupational therapists. Patients will document the date that they are able to fully weight bear without walking aids in the provided reporting log for assessment purpose. Adherence to weight bearing status will be assessed through participants interviews at the end of the study.
Sponsors
Blair Mason
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
Unilateral ankle fractures requiring open reduction internal fixation Fracture patterns will include with isolated medial or lateral malleolus fractures, bimalleolar and trimalleolar fractures Closed fracture Fractures whose post-operative stability has been confirmed by operating surgeons Participants who are available to attend follow-up in Christchurch Hospital. Participants must be physically active (with or without walking aids) in the community before the injury
Exclusion criteria
Fractures where stability is still questionable following fixation by the operating surgeon, Open fracture. Compound fracture Pathological fracture Non-ambulator pre-injury Active infection at the surgical site Concurrent injuries that preclude adhering to the follow up protocol Inability to cooperate protocol due to neurologic disorders (i.e., cognitive impairment, substance abuse, mental illness, intellectual disability, and dense peripheral neuropathy) or significant additional physical impairment (i.e., polytrauma patients with other limb, head or visceral injuries).
Outcome results
None listed