Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study.

The safety and efficacy of Hyruan ONE (test product), an intra-articular cross-linked sodium hyaluronate injection, to treat mild-to-moderate knee osteoarthritis was compared with that of Durolane (comparator) in a prospective, active-controlled, parallel-group, double-blind (masked-observed), multicenter non-inferiority study. European patients (n = 284) were randomized 1:1 (test product:comparator) and received one injection of cross-linked hyaluronic acid (60 mg/3 mL). In total, 280 patients completed the study. The primary endpoint of mean change in Western Ontario and McMaster University (WOMAC)-Likert Pain sub-scores from baseline at week 13 revealed changes of -5.59 and -5.54 for the test and comparator groups, respectively, demonstrating non-inferiority of the test product (difference, -0.05 [95% confidence interval, -0.838 to 0.729]). Secondary endpoint results, which included changes in WOMAC-Likert Pain sub-score from baseline to 26 weeks post-injection and changes in WOMAC-Likert Total score and Physical Function and Stiffness sub-scores, changes in patients' and investigators' global assessments, use of rescue medication, and responder rates at 13 and 26 weeks post-injection were similar between the groups. Incidence of adverse events was also similar. In both groups, most treatment-emergent adverse events were mild/moderate. Hyruan ONE was non-inferior to the comparator at 13 weeks post-injection in European patients with mild-to-moderate knee osteoarthritis.

Comparison of Patient-Reported Outcome Measurements and Objective Measurements after Cubital Tunnel Decompression.

BACKGROUND: The aims of this study were (1) to compare the responsiveness of disease and hand-related issues, including health status-related questions, in patients with cubital tunnel syndrome; and (2) to assess whether these tools and objective hand tests are associated with the results of nerve conduction studies after a simple cubital tunnel syndrome decompression. METHODS: Forty-seven patients with diagnosed condition were enrolled in the study. The following tools were used preoperatively and again at 3 and 6 months: the Patient-Rated Ulnar Nerve Evaluation; the Michigan Hand Outcomes Questionnaire; the Disabilities of the Arm, Shoulder, and Hand; the 12-Item Short-Form Health Survey; the pain visual analogue scale with activity; the grip and key pinch test, two-point discrimination, and the ulnar nerve conduction studies test. RESULTS: All questionnaires and pain visual analogue scale, two-point discrimination, and nerve conduction studies improved significantly at the 6-month follow-up (p < 0.05) compared with preoperative outcomes. Correlations were observed between preoperative motor conduction velocity, preoperative work of the Michigan Hand Outcomes Questionnaire (R = -0.38; p = 0.049), and pain visual analogue scale during activity (R = 0.47; p = 0.025). A correlation was found between motor conduction velocity change after 6 months and the hand function of the Michigan Hand Outcomes Questionnaire after 6 months (R = 0.57; p = 0.017). CONCLUSION: The Patient-Rated Ulnar Nerve Evaluation and the Michigan Hand Outcomes Questionnaire were more responsive for short-term recovery compared with other measures; however, only the latter correlated with motor conduction velocity.

[Interlocking intramedullary nail with reaming of bone marrow cavity in treatment of tibia and femur pseudarthrosis]. / Blokowany gwózdz sródszpikowy z rozwiercaniem jamy szpikowej w leczeniu stawów rzekomych kosci udowej i piszczelowej.

The aim of this paper was to assess the results of treatment of pesudoarthrosis of the tibia and femur with reamed interlocked intramedullary nailing. A group of 17 patients with pseudoarthrosis of long bones were treated. Pseudoarthrosis were located in 10 cases in the tibia and in 7 cases in the femur. In the analysed group there were 14 male and 3 female patients (average age: 48 years). All patients were treated by locked intramedullary nailing. Complete bone union was observed in 15 cases, 1 case is still under observation (radiological signs of bone union are already evident) and in 1 case treatment failed to resolve the pseudoarthrosis. Intramedullary interlocking nailing in the treatment of long bone pseudoarthrosis give very good stability and creates very good conditions for blood vessel penetration between the bone fragments. The reaming procedure yields biologically active material that accelerates the bone union process.