Efficacy of a single intra-articular injection of ultra-high molecular weight hyaluronic acid for hip osteoarthritis: a randomized controlled study.

BACKGROUND: Viscosupplementation with hyaluronic acid (HA) is increasingly used for the treatment of hip osteoarthritis (OA). The purpose of this study was to compare the efficacy of intra-articular injections of an ultra-high molecular weight viscosupplement (UHMW-HA, Fermathron S) with a medium molecular weight hyaluronan (MMW-HA, Hyalubrix 60) in hip OA. METHODS: Fifty-four patients with hip OA grade 3 on the Kellgren/Lawrence scale were randomized. All infiltrations were performed under ultrasound guidance. Evaluation was performed preoperatively and at 1, 3, 6 and 12 months after infiltration. Patients were clinically evaluated using Lequesne index, VAS and WOMAC score. RESULTS: Fifty patients, including 27 in the MMW-HA group and 23 in the UHMW-HA group, completed the follow-up. No significant difference was found between the two groups in terms of VAS, WOMAC or Lequesne index preoperatively or at 1, 3, 6 and 12 months after viscosupplementation. A stratified analysis was performed to study the development over time of Lequesne index of patients aged ≤ 55 years, > 55 and, ≤ 70 years and > 70 years and Lequesne index was different between the three age-stratified subgroups only in the MMW-HA group. The subgroup of older patients showed a higher Lequesne index than the subgroups of younger patients (p < 0.05). CONCLUSIONS: UHMW-HA is a safe and effective treatment for hip osteoarthritis. A single dose of UHMW-HA was as effective as two doses of MMW-HA resulting in similar reductions of pain and disability. STUDY DESIGN: Multicenter, independent, prospective, randomized controlled trial with level of evidence 1.

Complications in proximal humeral fractures.

Necrosis of the humeral head, infections and non-unions are among the most dangerous and difficult-to-treat complications of proximal humeral fractures. The aim of this work was to analyse in detail non-unions and post-traumatic bone defects and to suggest an algorithm of care. Treatment options are based not only on the radiological frame, but also according to a detailed analysis of the patient, who is classified using a risk factor analysis. This method enables the surgeon to choose the most suitable treatment for the patient, thereby facilitating return of function in the shortest possible time. The treatment of such serious complications requires the surgeon to be knowledgeable about the following possible solutions: increased mechanical stability; biological stimulation; and reconstructive techniques in two steps, with application of biotechnologies and prosthetic substitution.

Clinical effectiveness of Osigraft in long-bones non-unions.

Current evidence, based primarily on case series, suggest that the eptotermin alfa (recombinant bone morphogenetic protein-7 (rhBM-7)), which is commercialized as Osigraft with an indication for tibial non-union, used in monotherapy or polytherapy, is a safe and effective therapy for long bones non-unions of lower and upper limbs. No previous study has compared the safety and the efficacy of Osigraft and the "gold standard" treatment for recalcitrant long-bones non-union, autologous bone graft (ABG). This study aims to compare the effectiveness of Osigraft and ABG in the treatment of post-traumatic, persistent long bone non-unions. In particular, the present study will focus exclusively on complex persistent non-unions, excluding simpler cases, in which it is likely that a simple revision of the osteosynthesis will be sufficient to promote union, and extremely severe cases in which there is an indication for amputation and prosthesis. The study addresses the following research question: 1. Is the effectiveness of eptotermin alfa comparable to that of ABG in the treatment of complex long bone non-unions? 2. Are there significant differences in the prevalence of adverse events between patients treated with eptotermin alfa and those treated with ABG? The study is an observational, retrospective study, located in one Experimental Recruiting Center (Ospedale Universitario G. PINI - Milano). The study was conducted with ethics approval and according with the existing Italian law. Demographic and clinical data were collected from patients Clinical Medical Records and other existing documentation, through a web based eCRF. The treatment (surgery with Osigraft or ABG) effectiveness was evaluated comparing the number of success cases (primary endpoint) and the length for clinical and radiological healing (secondary end-points). The treatment safety was evaluating comparing the prevalence of Adverse Events. Osigraft was demonstrated to be statistically equivalent to ABG with respect to the primary and secondary end point of surgical success. The treatment success was statistically comparable across all the anatomical regions considered, both in patients treated with Osigraft and in patients treated with ABG. The use of Osigraft when compared to autograft was associated with statistically lower intraoperative blood loss and shorter operative times. In addition patients treated with Osigraft developed statistically less peri-operative and late onset adverse events, compared to ABG. The difference was substantially due to the occurrence of pain at donor site in patients treated with ABG.