Important Orthopaedic Trials
The AIM trial compared closed contact casting vs ORIF in patients over 60 with unstable ankle fractures.
Primary outcome was Olerud-Molander Ankle Score (OMAS) at 6 months.
Closed contact casting provides a clinically equivalent outcome to ORIF at a reduced cost to the NHS and society at 6 months.
FAIM trial is underway looking at comparing closed contact casting vs ORIF in patients with unstable ankle fractures below 60 years old. It is a follow on from the AIM trial.
Randomised control trial comparing early fixation and cast immobilisation of scaphoid waist fractures displaced by 2mm or less.
The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation.
There was no significant difference in mean PRWE between the two groups.
Scaphoid waist fractures displaced by 2mm or less should be treated with cast immobilisation. If signs of non-union then surgical fixation should occur.
The PROximal Fracture of the Humerus: Evaluation by Randomisation trial is a multicentre randomised controlled trial evaluating the clinical and cost effectiveness of surgical and non-surgical treatment for proximal fractures of the humerus in adults.
Inclusion criteria were those over 16 presenting within 3 weeks of their injury with a displaced fracture of the proximal humerus involving the surgical neck.
Primary outcome was the Oxford Shoulder Score assessed at 6, 12, and 24 months.
There was no significant difference in OSS between the two groups.
The DRAFFT trial is a randomised control trial that compared K wire and locking plate fixation of dorsally displaced fractures of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation.
Primary outcome measure was patient rated wrist evaluation (PRWE).
There was no difference between the two. K wire fixation is however quicker and cheaper to perform.
The heel fracture trail was a blinded randomised control trial comparing non-operative and ORIF management of displaced intra-articular calcaneal fractures.
There was no symptomatic or functional advantages after two years in patients with typical displaced intra-articular fractures.
Criticism: 73 patients at 22 hospitals received operation (low numbers per centre)
This is an ongoing trial looking at surgical reduction vs non-surgical casting for severely displaced off-ended distal radius fractures in children aged 4-10 years old.
The primary outcome is the patient reported outcomes measurement information system upper extremity score for children.