Routine fixation of displaced midshaft clavicle fractures is not cost-effective: a cost analysis from a randomized controlled trial.

AIMS: The primary aim of this study was to establish the cost-effectiveness of the early fixation of displaced midshaft clavicle fractures. PATIENTS AND METHODS: A cost analysis was conducted within a randomized controlled trial comparing conservative management (n = 92) versus early plate fixation (n = 86) of displaced midshaft clavicular fractures. The incremental cost-effectiveness ratio (ICER) was used to express the cost per quality-adjusted life-year (QALY). The Six-Dimension Short-Form Health Survey (SF-6D) score was used as the preference-based health index to calculate the cost per QALY at 12 months after the injury. RESULTS: The mean 12-month SF-6D was 0.9522 (95% confidence interval (CI) 0.9355 to 0.9689) following conservative management and 0.9607 (95% CI 0.9447 to 0.9767) following fixation, giving an advantage for fixation of 0.0085, which was not statistically significant (p = 0.46). The mean cost per patient was £1322.69 for conservative management and £5405.32 for early fixation. This gave an ICER of £480 309.41 per QALY. For a threshold of £20 000 per QALY, the benefit of fixation would need to be present for 24 years to be cost-effective compared with conservative treatment. Linear regression analysis identified nonunion as the only factor to adversely influence the SF-6D at 12 months (p < 0.001). CONCLUSION: Routine plate fixation of displaced midshaft clavicular fractures is not cost-effective. Nonunion following conservative management has an increased morbidity with comparable expense to early fixation. This may suggest that a targeted approach of fixation in patients who are at higher risk of nonunion would be more cost-effective than the routine fixation of all displaced fractures. Cite this article: Bone Joint J 2019;101-B:995-1001.

The Influence of Shortening on Clinical Outcome in Healed Displaced Midshaft Clavicular Fractures After Nonoperative Treatment.

BACKGROUND: We aimed to evaluate the effect of clavicular shortening, measured with 3-dimensional computed tomography (3DCT), on functional outcomes and satisfaction in patients with healed displaced midshaft clavicular fractures up to 1 year following injury. METHODS: The data used in this study were collected as part of a multicenter, prospective randomized controlled trial of open reduction and plate fixation compared with nonoperative treatment for acute, displaced midshaft clavicular factures. Patients who were randomized to nonoperative treatment and had healed by 1 year were included in the present study. Clavicular shortening relative to the uninjured, contralateral clavicle was measured on 3DCT. Outcome analysis was conducted at 6 weeks, 3 months, 6 months, and 1 year following injury and included the Disabilities of the Arm, Shoulder and Hand (DASH), Constant, and Short Form-12 (SF-12) scores and patient satisfaction. RESULTS: In the original trial, 105 patients were randomized to nonoperative treatment. Thirteen patients were lost to follow-up, leaving 92 patients, and an additional 16 (17%) developed nonunion and were excluded from the present study. Of the remaining 76 patients, 48 who had a 3DCT scan that included the whole length of both clavicles were included in the present study. The shortening of the injured clavicles, relative to the contralateral side, was a mean (and standard deviation) of 11.3 ± 7.6 mm, with a mean proportional shortening of 8%. Proportional shortening did not significantly correlate with the DASH (p ≥ 0.42), Constant (p ≥ 0.32), or SF-12 (p ≥ 0.08) scores at any point during follow-up. There was no significant difference in the mean DASH or Constant scores at any follow-up time point when the cutoff for shortening was defined as 1 cm (p ≥ 0.11) or as 2 cm (p ≥ 0.35). There was no significant difference in clavicular shortening between satisfied and unsatisfied patients (p ≥ 0.49). CONCLUSIONS: The present study demonstrated no association between shortening and functional outcome or satisfaction in patients with healed displaced midshaft clavicular fractures up to 1 year following injury. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Smoking status and the Disabilities of the Arm Shoulder and Hand score are early predictors of symptomatic nonunion of displaced midshaft fractures of the clavicle.

AIMS: This study identifies early risk factors for symptomatic nonunion of displaced midshaft fractures of the clavicle that aid identification of an at risk group who may benefit from surgery. METHODS: We performed a retrospective study of 88 patients aged between 16 and 60 years that were managed non-operatively. RESULTS: The rate of symptomatic nonunion requiring surgery was 14% (n = 13). Smoking (odds ratio (OR) 40.76, 95% confidence intervals (CI) 1.38 to 120.30) and the six week Disabilities of the Arm Shoulder and Hand (DASH) score (OR 1.11, 95% CI 1.01 to 1.22, for each point increase) were independent predictors of nonunion. A six week DASH score of 35 or more was identified as a threshold value to predict nonunion using receiver operating characteristic curve analysis. Smoking and the threshold value in the DASH and were additive risk factors for nonunion, when neither were present the risk of nonunion was 2%, if one or the other were present the nonunion rate was between 17% to 20%, and if both were present the rate increased to 44%. DISCUSSION: Patients with either of these risk factors, which include approximately half of all patients sustaining displaced midshaft fractures of the clavicle, are at an increased risk of developing a symptomatic non-union. TAKE HOME MESSAGE: Smoking and failure of functional return at six weeks are significant predictors of nonunion of the midshaft of the clavicle. Such patients warrant further investigation as to whether they would benefit from early surgical fixation in order to avoid the morbidity of a nonunion.

Open reduction and plate fixation versus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter, randomized, controlled trial.

BACKGROUND: There is a growing trend to treat displaced midshaft clavicular fractures with primary open reduction and plate fixation; whether such treatment results in improved patient outcomes is debatable. The aim of this multicenter, single-blinded, randomized controlled trial was to compare union rates, functional outcomes, and economic costs for displaced midshaft clavicular fractures that were treated with either primary open reduction and plate fixation or nonoperative treatment. METHODS: In a prospective, multicenter, stratified, randomized controlled trial, 200 patients between sixteen and sixty years of age who had an acute displaced midshaft clavicular fracture were randomized to receive either primary open reduction and plate fixation or nonoperative treatment. Functional assessment was conducted at six weeks, three months, six months, and one year with use of the Disabilities of the Arm, Shoulder and Hand (DASH) and Constant scores. Union was evaluated with use of three-dimensional computed tomography. Complications were recorded, and an economic evaluation was performed. RESULTS: The rate of nonunion was significantly reduced after open reduction and plate fixation (one nonunion) as compared with nonoperative treatment (sixteen nonunions) (relative risk = 0.07; p = 0.007). Group allocation to nonoperative treatment was independently predictive of the development of nonunion (p = 0.0001). Overall, DASH and Constant scores were significantly better after open reduction and plate fixation than after nonoperative treatment at the time of the one-year follow-up (DASH score, 3.4 versus 6.1 [p = 0.04]; Constant score, 92.0 versus 87.8 [p = 0.01]). However, when patients with nonunion were excluded from analysis, there were no significant differences in the Constant scores or DASH scores at any time point. Patients were less dissatisfied with symptoms of shoulder droop, local bump at the fracture site, and shoulder asymmetry in the open reduction and plate fixation group (p < 0.0001). The cost of treatment was significantly greater after open reduction and plate fixation (p < 0.0001). CONCLUSIONS: Open reduction and plate fixation reduces the rate of nonunion after acute displaced midshaft clavicular fracture compared with nonoperative treatment and is associated with better functional outcomes. However, the improved outcomes appear to result from the prevention of nonunion by open reduction and plate fixation. Open reduction and plate fixation is more expensive and is associated with implant-related complications that are not seen in association with nonoperative treatment. The results of the present study do not support routine primary open reduction and plate fixation for the treatment of displaced midshaft clavicular fractures.

Instability of the shoulder following seizures.

Dislocation of the shoulder may occur during seizures in epileptics and other patients who have convulsions. Following the initial injury, recurrent instability is common owing to a tendency to develop large bony abnormalities of the humeral head and glenoid and a susceptibility to further seizures. Assessment is difficult and diagnosis may be missed, resulting in chronic locked dislocations with protracted morbidity. Many patients have medical comorbidities, and successful treatment requires a multidisciplinary approach addressing the underlying seizure disorder in addition to the shoulder pathology. The use of bony augmentation procedures may have improved the outcomes after surgical intervention, but currently there is no evidence-based consensus to guide treatment. This review outlines the epidemiology and pathoanatomy of seizure-related instability, summarising the currently-favoured options for treatment, and their results.

Functional outcome following PCL and complex knee ligament reconstruction.

The purpose of this study was to evaluate the functional outcome of surgical reconstruction of the posterior cruciate ligament (PCL). In particular we wanted to document the recovery of knee muscle function. Twenty three patients underwent single bundle reconstruction of the PCL. There were four isolated PCL reconstructions. The remainder had PCL reconstructions combined with other ligament reconstructions. Patients were followed up at 2, 6, 12 and 26 weeks post operatively and underwent detailed functional assessment at 12 and 24 months. Outcome measures included the International Knee Documentation Committee (IKDC) score, the Tegner activity rating, and muscle dynamometry evaluating peak torque for knee flexion and extension. At final follow up 19 (83%) patients were rated as normal or nearly normal by the IKDC score. Seventeen (74%) patients returned to moderate or strenuous activity. Ligament stability was rated as normal or nearly normal in 20 (87%) patients. All 23 patients regained normal or nearly normal range of motion of the knee following surgery. Knee flexion peak torque demonstrated an average percentage deficit from the normal side of 24% at 12 months and 14% at 24 months. The deficits for extension were 35% and 9% for the same time points. PCL reconstruction is associated with a satisfactory clinical outcome but muscle function abnormalities may persist for 2 years.