None listed
Conditions
Brief summary
The primary purpose of the study is to identify whether the clinical outcomes of mid-shaft clavicle fractures treated with an operation involving fixation with a plate and then physiotherapy are superior to those treated with physiotherapy alone. The study hypothesis is that there will be no difference in outcomes between the two groups at one year after their injury and subsequent treatment.
Interventions
Surgical management of the fracture involving open reduction and internal fixation using a plate.
The operation will be performed at the earliest available time after the patient has been randomised. On average the operation will take between 60 and 90 minutes to perform. The operation will only be performed once on each patient unless there are complications requiring further surgery.
Post operatively the patients will be seen by a physiotherapist and given a guided 16 week physiotherapy progr
Surgical management of the fracture involving open reduction and internal fixation using a plate. The operation will be performed at the earliest available time after the patient has been randomised. On average the operation will take between 60 and 90 minutes to perform. The operation will only be performed once on each patient unless there are complications requiring further surgery. Post operatively the patients will be seen by a physiotherapist and given a guided 16 week physiotherapy program, exactly the same as that given to the control candidates. They will commence this on the day following their operation
Sponsors
Wellington Hospital Orthopaedic Unit
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
ALL of following 1. Completely displaced midshaft clavicle fracture 2. Fracture amenable to plate fixation (3 screws either side of fracture) 3.No medical contraindications to general anaesthesia 4.Able to provide informed consent
Exclusion criteria
ANY of the following 1. Age <16 or >60yrs 2. Fracture of proximal or distal 1/3 of clavicle 3. Pathological fracture 4. Open fracture 5. Fracture seen >28 days after injury 6. Associated neurovascular injury 7. Associated head injury (= GCS<12) 8. Upper extremity fracture distal to the shoulder 9. Inability to comply with follow up 10. Medical contraindication to general anaesthesia 11. Inability to provide consent
Outcome results
None listed