Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury.Aims
Methods
Distal radius fractures (DRFs) are common injuries that represent 17% of all adult upper extremity fractures. Some fractures deemed appropriate for nonsurgical management following closed reduction and casting exhibit delayed secondary displacement (greater than two weeks from injury) and require late surgical intervention. This can lead to delayed rehabilitation and functional outcomes. This study aimed to determine which demographic and radiographic features can be used to predict delayed fracture displacement. This is a multicentre retrospective case-control study using radiographs extracted from our Analytics Data Integration, Measurement and Reporting (DIMR) database, using diagnostic and therapeutic codes. Skeletally mature patients aged 18 years of age or older with an isolated DRF treated with surgical intervention between two and four weeks from initial injury, with two or more follow-up visits prior to surgical intervention, were included. Exclusion criteria were patients with multiple injuries, surgical treatment with fewer than two clinical assessments prior to surgical treatment, or surgical treatment within two weeks of injury. The proportion of patients with delayed fracture displacement requiring surgical treatment will be reported as a percentage of all identified DRFs within the study period. A multivariable conditional logistic regression analysis was used to assess case-control comparisons, in order to determine the parameters that are mostly likely to predict delayed fracture displacement leading to surgical management. Intra- and inter-rater reliability for each radiographic parameter will also be calculated. A total of 84 age- and sex-matched pairs were identified (n=168) over a 5-year period, with 87% being female and a mean age of 48.9 (SD=14.5) years. Variables assessed in the model included pre-reduction and post-reduction radial height, radial inclination, radial tilt, volar cortical displacement, injury classification, intra-articular step or gap, ulnar variance, radiocarpal alignment, and cast index, as well as the difference between pre- and post-reduction parameters. Decreased pre-reduction radial inclination (Odds Ratio [OR] = 0.54; Confidence Interval [CI] = 0.43 – 0.64) and increased pre-reduction volar cortical displacement (OR = 1.31; CI = 1.10 – 1.60) were significant predictors of delayed fracture displacement beyond a minimum of 2-week follow-up. Similarly, an increased difference between pre-reduction and immediate post reduction radial height (OR = 1.67; CI = 1.31 – 2.18) and ulnar variance (OR = 1.48; CI = 1.24 – 1.81) were also significant predictors of delayed fracture displacement. Cast immobilization is not without risks and delayed surgical treatment can result in a prolong recovery. Therefore, if reliable and reproducible radiographic parameters can be identified that predict delayed fracture displacement, this information will aid in earlier identification of patients with DRFs at risk of late displacement. This could lead to earlier, appropriate surgical management, rehabilitation, and return to work and function.
