A randomized controlled trial evaluating the short-term efficacy of a single-administration intramuscular injection with the fixed combination of thiocolchicoside-diclofenac versus diclofenac monotherapy in patients with acute moderate-to-severe low back pain.

BACKGROUND: Non-specific acute low back pain (LBP) is a common health problem that may be accompanied by muscle spasm and decreased mobility. The combination of non-steroidal anti-inflammatory drugs and muscle relaxants represents an advantageous therapeutic option, however, available data on their combined use are conflicting. This prospective, randomized, single-blind, two-parallel-group trial assessed the efficacy of a single intramuscular (IM) injection of the fixed-dose combination (FDC) diclofenac (75 mg)-thiocolchicoside (4 mg/4 ml) product (test treatment) compared to diclofenac (75 mg/3 ml) alone (reference treatment) for the symptomatic relief of acute LBP. Tolerability and safety were also assessed as secondary variables. METHODS: One hundred thirty-four patients were enrolled (safety population) and randomly allocated to the combination or single-agent regimen. Pain intensity and muscle spasm, assessed respectively by the patient-reported visual analogue scale and investigator-performed finger-to-floor distance test, were determined prior to the injection as well as 1 and 3 h post-injection in 123 patients (per-protocol population). The patients were blinded to treatment. Safety was assessed up to 24 h post-injection. RESULTS: The test treatment was superior in both alleviating the pain intensity and reducing the finger-to-floor distance at both 1 (p < 0.01 and p = 0.023 respectively) and 3 h post-injection (p < 0.01). A higher percentage of patients experienced > 30% reduction in pain intensity at 1 and 3 h with the test treatment (p = 0.037 and p < 0.01 respectively). The corresponding VAS (SD) scores for the test treatment group were at baseline, 1 and 3 h post-injection 72.03 (± 11.72), 45.37 (± 16.28) and 31.56 (± 15.08) respectively and for the reference treatment group 65.20 (± 12.16), 48.98 (± 18.76) and 44.52 (± 17.33) respectively. No adverse effects were reported with the combination treatment, whereas two patients treated with diclofenac reported dizziness. CONCLUSIONS: The FDC treatment is an effective and well-tolerated option for the symptomatic treatment of LBP. Clinical and patient-reported assessments confirmed that a single IM injection of FDC diclofenac-thiocolchicoside was more effective than diclofenac alone in conferring rapid and sustained improvement in mobility and pain intensity. TRIAL REGISTRATION: EudraCT No: 2017-004530-29 Available at https://eudract.ema.europa.eu/ Registered 04 Dec 2017.

Mechanical comparison of two types of fixation for ludloff oblique first metatarsal osteotomy.

The Ludloff oblique metatarsal osteotomy is an effective method to correct hallux valgus deformity, although a number of problems have been associated with it, including inherent instability, delayed union, dorsal malunion, and fixation failure. The purpose of the present study was to compare the mechanical characteristics of fixation of the Ludloff osteotomy in 20 identical synthetic bone models, 10 fixated using 2 screws (group I) and 10 fixated using 2 screws augmented with a mini locking plate (group II). Each specimen was loaded to failure, and the mean average load to failure, stiffness, and absorbed energy to failure were compared using unpaired Student's t test. The mean average stiffness of the Ludloff osteotomy fixed with 2 screws (group I) and with the supplementary mini locking plate (group II) was 172.7 ± 31.7 N/mm and 193.3 ± 39 N/mm, respectively (p = .21). The mean average load to failure for groups I and II was 278.4 ± 64.4 N and 356.2 ± 77.9 N, respectively (p = .025). The mean average energy absorbed before failure for groups I and II was 506.7 ± 206.4 Nmm and 769.8 ± 339.4 Nmm, respectively (p = .05). The use of a medially applied supplementary mini locking plate offers a simple and effective method to improve the mechanical stability of the Ludloff oblique osteotomy.

Biplane fracture of the distal humeral lateral column: a report of two cases.

Articular fractures of the distal part of the humerus represent a challenging therapeutic problem, because they require thorough understanding of the complex local anatomy, extensile approaches, and reduction and fixation of small fragments that mainly consist of subchondral bone and articular cartilage. This report presents two cases of a unique fracture pattern of the lateral humeral column with a fracture line in the coronal plane separating the capitellum with a substantial portion of the lateral trochlear ridge, and with a second fracture line in the sagittal plane separating the residual, posterior portion of the lateral column, almost through the level of the capitellotrochlear sulcus, thus creating concomitant but distinct "low" lateral column and capitellum fractures. The radiographic findings that would suggest to the orthopaedic surgeon the possibility of this fracture pattern, the surgical approach that provides access to this complex articular fracture, and the fixation method are described.