Plate fixation of midshaft clavicular fractures: patient-reported outcomes and hardware-related complications.

BACKGROUND: Recent studies report high hardware removal rates after plate fixation of midshaft clavicular fractures. Precontoured clavicle plates may decrease hardware-related complications while improving healing rates and patient-reported outcomes (PROs). METHODS: Using a private-payer national database, we identified 7826 patients who underwent clavicle open reduction and internal fixation (ORIF) in 2007 to 2011. Database patients were tracked for 2 years to assess hardware removal and revision fixation. In addition, we retrospectively identified 73 patients who underwent plate fixation of midshaft clavicular fractures at our institution. These patients completed the Disabilities of Arm, Shoulder and Hand (DASH) assessment, the EQ-5D (EuroQol, Rotterdam, The Netherlands) quality of life assessment, and a hardware-related outcomes survey. RESULTS: Among 7826 database patients, 994 (12.7%) underwent hardware removal and 78 (1%) required revision ORIF. The annual incidence of clavicle ORIF increased 61.5% between 2007 and 2011. In our institutional cohort, 56 patients (77%) were fixed with precontoured plates and 17 (23%) with standard plates. At a mean follow-up of 4.2 years, 11 patients (15%) underwent hardware removal and 1 patient (1.4%) experienced nonunion. Patients reported excellent outcomes, with average DASH of 4.0 ± 8.9 and EQ-5D of 0.89 ± 0.19. There were no differences in PROs, hardware removal, or union rate between plate types, although our study was underpowered for these outcomes. Patients who underwent hardware removal reported lower DASH, EQ-5D, satisfaction, and shoulder function compared with patients with hardware retained. Women were more likely to undergo hardware removal in the institutional (P = .009) and the database (P < .001) cohorts. CONCLUSION: Displaced midshaft clavicle fractures have high union rates with precontoured plate fixation. Women are 4 times more likely than men to have hardware removed. Patients undergoing clavicle hardware removal report worse long-term outcomes than patients with hardware retained.

Accuracy of MRI evaluation of meniscus tears in the setting of ACL injuries.

BACKGROUND: Our purpose was to evaluate the diagnostic performance of magnetic resonance imaging (MRI) for the pre-operative detection of meniscus tears requiring operative intervention, and identify factors that determined accuracy of diagnosing meniscus tears, in the setting of anterior cruciate ligament (ACL) reconstruction. METHODS: Patients who underwent primary ACL reconstruction were retrospectively reviewed. A meniscus tear was classified as requiring treatment if it was debrided or repaired at the time of ACL reconstruction. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of pre-operative MRIs were determined for medial and lateral meniscus tears. RESULTS: Sensitivity, specificity, PPV, and NPV of MRI were 0.90, 0.75, 0.58, and 0.95 for medial meniscus tears, respectively, and 0.67, 0.81, 0.65, and 0.82 for lateral meniscus tears. MRI-diagnosed medial meniscus tears were associated with a longer time interval between initial injury and imaging compared to ACL tears without concomitant meniscus injury on MRI (p=0.038). Vertical medial meniscus tears were less likely than other tear patterns to require treatment at the time of ACL reconstruction (p=0.03). MRI showed a higher diagnostic performance for lateral meniscus tears when surgery was performed within 30days of imaging. CONCLUSIONS: This study demonstrates only moderate sensitivity and specificity of pre-operative MRI in the detection of meniscus tears requiring operative treatment in the setting of ACL injury. High rates of false diagnoses were observed, suggesting MRI may not be as accurate in predicting positive or negative meniscus findings at the time of ACL reconstruction as previously reported. LEVEL OF EVIDENCE: Level III.

Results availability for analgesic device, complex regional pain syndrome, and post-stroke pain trials: comparing the RReADS, RReACT, and RReMiT databases.

Evidence-based medicine rests on the assumption that treatment recommendations are robust, free from bias, and include results of all randomized clinical trials. The Repository of Registered Analgesic Clinical Trials search and analysis methodology was applied to create databases of complex regional pain syndrome (CRPS) and central post-stroke pain (CPSP) trials and adapted to create the Repository of Registered Analgesic Device Studies databases for trials of spinal cord stimulation (SCS), repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (tDCS). We identified 34 CRPS trials, 18 CPSP trials, 72 trials of SCS, and 92 trials of rTMS/tDCS. Irrespective of time since study completion, 45% of eligible CRPS and CPSP trials and 46% of eligible SCS and rTMS/tDCS trials had available results (peer-reviewed literature, results entered on registry, or gray literature); peer-reviewed publications could be found for 38% and 39%, respectively. Examining almost 1000 trials across a spectrum of painful disorders (fibromyalgia, diabetic painful neuropathy, post-herpetic neuralgia, migraine, CRPS, CPSP) and types of treatment, no single study characteristic consistently predicts unavailability of results. Results availability is higher 12 months after study completion but remains below 60% for peer-reviewed publications. Recommendations to increase results availability include supporting organizations advocating for transparency, enforcing existing results reporting regulations, enabling all primary registries to post results, stating trial registration numbers in all publication abstracts, and reducing barriers to publishing "negative" trials. For all diseases and treatment modalities, evidence-based medicine must rigorously adjust for the sheer magnitude of missing results in formulating treatment recommendations.

How transparent are migraine clinical trials? Repository of Registered Migraine Trials (RReMiT).

Transparency in research requires public access to unbiased information prior to trial initiation and openly available results upon study completion. The Repository of Registered Migraine Trials is a global snapshot of registered migraine clinical trials and scorecard of results availability via the peer-reviewed literature, registry databases, and gray literature. The 295 unique clinical trials identified employed 447 investigational agents, with 30% of 154 acute migraine trials and 11% of 141 migraine prophylaxis trials testing combinations of agents. The most frequently studied categories in acute migraine trials were triptans, nonsteroidal anti-inflammatory drugs, antiemetics, calcitonin gene-related peptide antagonists, and acetaminophen. Migraine prophylaxis trials frequently studied anticonvulsants, ß-blockers, complementary/alternative therapies, antidepressants, and botulinum toxin. Overall, 237 trials were eligible for a results search. Of 163 trials completed at least 12 months earlier, 57% had peer-reviewed literature results, and registries/gray literature added another 13%. Using logistic regression analysis, studies with a sample size below the median of 141 subjects were significantly less likely to have results, but the dominant factor associated with availability of results was time since study completion. In unadjusted models, trials registered on ClinicalTrials.gov and trials with industry primary sponsorship were significantly more likely to have results. Recently completed trials rarely have publicly available results; 2 years after completion, the peer-reviewed literature contains results for fewer than 60% of completed migraine trials. To avoid bias, evidence-based therapy algorithms should consider factors affecting results availability. As negative trials are less likely to be published, special caution should be exercised before recommending a therapy with a high proportion of missing trial results.

RReACT goes global: perils and pitfalls of constructing a global open-access database of registered analgesic clinical trials and trial results.

Eliminating publication bias requires ensuring public awareness of studies and access to results. Clinical trial registries provide basic trial information, but access to unbiased trial results is inadequate. Nearly all studies of trial registration and results reporting have been limited to the ClinicalTrials.gov registry. We analyzed trial registration, registry functionality, cross-registry harmonization, and results reporting on all 15 primary registries in the World Health Organization International Clinical Trials Registry Platform (ICTRP) for postherpetic neuralgia, painful diabetic neuropathy, and fibromyalgia. A total of 447 unique trials were identified, with 86 trials listed on more than one registry. A comprehensive search algorithm was used to find trial results in the peer-reviewed literature and the grey literature. Creating a global database of registered trials and trial results proved surprisingly difficult for several reasons: (1) ICTRP does not reliably identify trials listed on multiple registries, manual searches are necessary; (2) Searching ICTRP yields different results than searching individual registries; (3) Outcome measure descriptions for multiply registered trials vary between registries; (4) Registry-publication pairings are often inaccurate or incomplete; (5) Grey literature results are not permanent. Overall, only 46% of all trials had results available. Trials registered on ClinicalTrials.gov were significantly more likely to have results (52% vs. 18%, P<0.001), partly due to the ability to post results directly to the registry. In addition to the simple remedy of including trial registration numbers on all meeting abstracts and peer-reviewed papers, specific strategies are offered to facilitate identifying multiply registered studies and ensuring accurate pairing of results and publications.