This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture. 70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL). At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups. Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr.
This prospective randomised trial aimed to assess the superiority of internal fixation of well-reduced medial malleolar fractures (displacement □2mm) compared with non-fixation, following fibular stabilisation in patients undergoing surgical management of a closed unstable ankle fracture. A total of 154 adult patients with a bi- or trimalleolar fracture were recruited from a single centre. Open injuries and vertically unstable medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at 12 months post-randomisation. Complications were documented over the follow-up period. The baseline group demographics and injury characteristics were comparable. There were 144 patients reviewed at the primary outcome point (94%). The median OMAS was 80 (IQR, 60-90) in the fixation group vs. 72.5 (IQR, 55-90) in the non-fixation group (p=0.165). Complication rates were comparable, although significantly more patients (n=13, 20%) in the non-fixation group developed a radiographic non-union (p<0.001). The majority (n=8/13) were asymptomatic, with one patient requiring surgical reintervention. In the non-fixation group, a superior outcome was associated with an anatomical medial malleolar fracture reduction. Internal fixation is not superior to non-fixation of well-reduced medial malleolar fractures when managing unstable ankle fractures. However, one in five patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the longer-term consequences of this are unknown. The results of this trial may support selective non-fixation of anatomically reduced fractures.
It is unclear whether acute plate fixation facilitates earlier return of normal shoulder function following a displaced mid-shaft clavicular fracture compared with nonoperative management when union occurs. The primary aim of this study was to establish whether acute plate fixation was associated with a greater return of normal shoulder function when compared with nonoperative management in patients who unite their fractures. The secondary aim was to investigate whether there were identifiable predictors associated with return of normal shoulder function in patients who achieve union with nonoperative management. Patient data from a randomized controlled trial were used to compare acute plate fixation with nonoperative management of united fractures. Return of shoulder function was based on the age- and sex-matched Disabilities of the Arm, Shoulder and Hand (DASH) scores for the cohort. Independent predictors of an early recovery of normal shoulder function were investigated using a separate prospective series of consecutive nonoperative displaced mid-shaft clavicular fractures recruited over a two-year period (aged ≥ 16 years). Patient demographics and functional recovery were assessed over the six months post-injury using a standardized protocol.Aims
Methods
