Comparison of CFR-PEEK and conventional titanium locking plates for proximal humeral fractures: a retrospective controlled study of patient outcomes.

BACKGROUND: Metal plates are the fixation devices used most frequently to proximal humeral fractures (PHFs). However, in recent years carbon fiber-reinforced polyetheretherketone (CFR-PEEK) plates have become increasingly common. This study compares the clinical and radiographic outcomes of 42 Neer three- and four-part PHFs treated with CFR-PEEK or metal (titanium) plates. MATERIALS AND METHODS: Forty-two PHF patients were managed with CFR-PEEK plates (n = 21, males/females 9/12; mean age 57.4 years; mean follow-up 30.7 months; CFR-PEEK group) or metal plates (n = 21; males/females 7/14; mean age 55.8 years; mean follow-up 52.7 months; Metal group). Active shoulder mobility (anterior elevation, lateral elevation, external rotation, and internal rotation), the Constant-Murley Score, the Simple Shoulder Test Score, and the pain score were recorded. Preoperative computed tomography scans and X-rays were obtained. Postoperative fracture healing and displacement, tuberosity resorption and/or malposition, hardware position, and cortical thinning (CT) under the plate were assessed radiographically. RESULTS: Shoulder mobility, clinical, and pain scores were similar in both patient groups. CT was significantly greater in CFR-PEEK patients (mean difference, 1.14 mm; p = 0.0003). In both groups, incomplete or poor calcar reduction was associated to a significantly higher complication rate, especially stiffness and muscle weakness (p = 0.016). The rate of tuberosity resorption was significantly higher in the Metal group (p = 0.040). Two patients required revision to a hemiarthroplasty (CFR-PEEK) and reverse arthroplasty (Metal group). CONCLUSIONS: CFR-PEEK plates provide a viable alternative to conventional titanium plates in PHFs, ensuring similar clinical outcomes and a lower rate of tuberosity resorption, but they involve higher stress shielding under the plate.

A multi-centre, open label, long-term follow-up study to evaluate the benefits of a new viscoelastic hydrogel (Hymovis®) in the treatment of knee osteoarthritis.

OBJECTIVE: To evaluate the long-term efficacy and safety of Hymovis® in the symptomatic treatment of knee osteoarthritis (OA). PATIENTS AND METHODS: This is a prospective, multi-center, open label, phase III clinical study. Two intra-articular injections (3 mL) of Hymovis® (8 mg/mL HYADD® 4) were administered 1 week apart at the beginning of the study on day 0 and day 7 and after 6 months from baseline, on day 182 and 189. Follow-up assessment were conducted for 52 weeks. 50 subjects, > 40 years old, with knee OA, with clinical and radiological confirm, complain pain in the target knee were enrolled. The variables considered were: WOMAC questionnaire, Joint Space Width (JSW), OMERACT OARSI responder criteria, EQ-5D questionnaire, rescue medication consumption. RESULTS: After the injections of Hymovis®, pain perceived by the patient when walking on a flat surface (WOMAC A1 score) significantly improves at the end of the study respect to the baseline. WOMAC stiffness, physical function and total score significantly improve during the study since 3 months after treatment, and it is maintained up to the end of the study (p < 0.001). By the x-ray analysis of knee, a radiological progression of OA was observed in the 26% of patients at the end of the study, while 88% of patients result to be responder to the therapy classified as per OMERACT-OARSI criteria. The EQ-5D weighted index increased significantly, against baseline, at each study time point (p < 0.001). Investigator's and patient's global assessment of the disease measured by the VAS both show a marked improvement in patient's health conditions. CONCLUSIONS: Results from this study confirm that Hymovis® alleviate the knee pain since the first treatment cycle. The patients treated with two cycles of intra-articular injections of Hymovis® have a progressive pain reduction that is maintained up to one year after the treatment start with improve of all the scores considered in this study. Hymovis® is effective and safe in symptomatic treatment of painful knee OA.