This multi-centre single-blind randomised control trial compared outcomes in patients with acute displaced mid-shaft clavicle fractures treated either by primary open reduction and plate fixation (ORPF), or non-operative treatment (NT). Two-hundred patients were randomised to receive either ORPF or NT. Functional assessment was conducted up to one-year using DASH, SF-12 and Constant scores (CS). Union was evaluated using radiographs and CT. Rate of non-union was significantly reduced after ORPF (1 following ORPF, 16 following NT, odds ratio=0.07, 95% CI=0.01–0.50, p=0.0006). 7 patients had delayed-union after NT. Group allocation to ORPF was independently predictive of development of non-union. DASH and CS were significantly better in the ORPF group 3-months post-surgery, but not at one-year (mean DASH = 6.2 after NT versus 3.7 after ORPF, p=0.09; mean CS = 86.1 after NT versus 90.7 after ORPF, p=0.05). Group allocation was not predictive of one-year outcome. Non-union was the only factor independently predictive of one-year functional outcome. There were no significant differences in time off work or subjective scores. Five patients underwent revision for complications after ORPF. 10 patients underwent metalwork removal. Treatment cost was significantly greater after ORPF (p=0.001). ORPF reduces rate of non-union compared with NT and is associated with better early functional outcomes. Improved outcomes are not sustained at one-year. Differences in functional outcome appear to be mediated by prevention of non-union from ORPF. ORPF is more expensive and associated with implant-related complications not seen with NT. Our results do not support routine primary ORPF for displaced mid-shaft clavicle fractures.
We conducted a multicentre two arm double blind randomised controlled trial to assess efficacy of pulsed ultrasound for accelerating the rate of bone healing. Sixty-two skeletally mature adults undergoing limb lengthening, of between 2.5cm to 10cm by distraction osteogenesis, at the proximal tibia using an Ilizarov frame were randomised to either an active or a placebo (control) ultrasound device. Primary outcome measure was time ready for removal of frame after adjusting for distraction length (days/cm) for both intension to treat (ITT) and per protocol (PP) patients. The time at which the frame was removed was determined by the maturation of the regenerate bone. Secondary outcomes were return to weight bearing and covariates affecting time to frame removal. The baseline characteristics of the two groups were well balanced, and 90% of patients were managed and followed up as PP. There was no difference in the time to frame removal between the two groups for the ITT (5.0days/cm, p=0.23) or the PP (10.1days/cm, p=0.054). There was no difference in return to weight bearing between the two groups, after adjusting for distraction length, for the ITT or PP patients (p>0.5). Smoking was the only covariate identified to increase the frame removal time (hazard ratio 0.46, 95% confidence interval 0.22 to 0.96; p=0.04). This trial demonstrated no difference in bone healing between those who underwent pulsed ultrasound and those who did not. Smoking was observed to have a significant inhibitory effect on bone healing.
To assess efficacy of pulsed ultrasound for accelerating regenerate consolidation. A multicentre two arm patient and assessor double blind RCTObjective:
Design:
The PROximal Fracture of the Humerus Evaluation by Randomisation
(PROFHER) randomised clinical trial compared the operative and non-operative
treatment of adults with a displaced fracture of the proximal humerus
involving the surgical neck. The aim of this study was to determine
the long-term treatment effects beyond the two-year follow-up. Of the original 250 trial participants, 176 consented to extended
follow-up and were sent postal questionnaires at three, four and
five years after recruitment to the trial. The Oxford Shoulder Score
(OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent
shoulder operations and fracture data were collected. Statistical
and economic analyses, consistent with those of the main trial were
applied.Aims
Patients and Methods
Fractures of the proximal femur are one of the
greatest challenges facing the medical community, constituting a
heavy socioeconomic burden worldwide. Controversy exists regarding
the optimal treatment for independent patients with displaced intracapsular fractures
of the proximal femur. The recognised alternatives are hemiarthroplasty
and total hip replacement. At present there is no established standard
of care, with both types of arthroplasty being used in many centres.
The principal advantages of total hip replacement are a functional
benefit over hemiarthroplasty and a reduced risk of revision surgery.
The principal criticism is the increased risk of dislocation. We
believe that an alternative acetabular component may reduce the
risk of dislocation but still provide the functional benefit of
total hip replacement in these patients. We therefore propose to
investigate the dislocation risk of a dual-mobility acetabular component
compared with standard polyethylene component in total hip replacement
for independent patients with displaced intracapsular fractures
of the proximal femur within the framework of the larger WHiTE (Warwick
Hip Trauma Evaluation) Comprehensive Cohort Study. Cite this article:
Fractures of the proximal femur are one of the
greatest challenges facing the medical community, constituting a
heavy socioeconomic burden worldwide. Controversy exists regarding
the optimal treatment for patients with unstable trochanteric proximal
femoral fractures. The recognised treatment alternatives are extramedullary
fixation usually with a sliding hip screw and intramedullary fixation
with a cephalomedullary nail. Current evidence suggests that best
results and lowest complication rates occur using a sliding hip screw.
Complications in these difficult fractures are relatively common
regardless of type of treatment. We believe that a novel device,
the X-Bolt dynamic plating system, may offer superior fixation over
a sliding hip screw with lower reoperation risk and better function.
We therefore propose to investigate the clinical effectiveness of
the X-bolt dynamic plating system compared with standard sliding
hip screw fixation within the framework of a the larger WHiTE (Warwick
Hip Trauma Evaluation) Comprehensive Cohort Study. Cite this article:
To synthesise the literature and perform a meta-analysis detailing
the longitudinal recovery in the first two years following a distal
radius fracture (DRF) managed with volar plate fixation. Three databases were searched to identify relevant articles.
Following eligibility screening and quality assessment, data were
extracted and outcomes were assimilated at the post-operative time
points of interest. A state-of-the-art longitudinal mixed-effects
meta-analysis model was employed to analyse the data.Aims
Materials and Methods
We reviewed 59 bone graft substitutes marketed
by 17 companies currently available for implantation in the United Kingdom,
with the aim of assessing the peer-reviewed literature to facilitate
informed decision-making regarding their use in clinical practice.
After critical analysis of the literature, only 22 products (37%)
had any clinical data. Norian SRS (Synthes), Vitoss (Orthovita),
Cortoss (Orthovita) and Alpha-BSM (Etex) had Level I evidence. We question
the need for so many different products, especially with limited
published clinical evidence for their efficacy, and conclude that
there is a considerable need for further prospective randomised
trials to facilitate informed decision-making with regard to the
use of current and future bone graft substitutes in clinical practice. Cite this article:
