Satisfactory clinical and radiologic outcomes with a new shorter and modular stem for end-stage hip osteoarthritis: an international prospective multicentre pilot study

Introduction: This multicenter prospective cohort study aimed to assess the safety and clinical and radiologic performance of the CLS® BreviusTM Stem with Kinectiv® Technology. Material and Methods: A total of 222 consecutive subjects, recruited in five different centers, qualifying for primary total hip arthroplasty (THA), were enrolled in the study. All the subjects received the CLS® BreviusTM Stem with Kinectiv® Technology. All the enrolled study subjects underwent pre-operative clinical and radiographic evaluation. Additionally, all subjects underwent post-operative clinical, functional and radiographic evaluations at 6 months and 1, 2, 3, and 5 years. These evaluations included implant survival, pain and functional performance (Harris Hip Score [HHS], University of California, Los Angeles [UCLA] Activity Score, Oxford Hip Score), subject quality-of-life (EQ-5D), radiographic parameters, complications, and concentration of metal ions (aluminum and titanium) in blood. Results: No revisions were performed during the follow-up period. Of the 222 patients, only 76 completed the 5-year follow-up. Only 7 and 5 patients had aluminum and titanium 5-year evaluations, respectively. All the clinical parameters showed an overall improvement in the overtime measured with ANOVA for repeated measures; furthermore, the clinical scores showed a statistically significant improvement at 5 years with respect to pre-operative value (p  0.05). A total of six complications were reported, of which only two were hip-related. Conclusions: The function of the CLS® BreviusTM Stem with Kinectiv® Technology indicated that subject well-being significantly increased following THA regardless of age, gender, BMI, previous surgery, primary diagnosis, and lifestyle

The example of real time migration assay of stimulated and controlled HUVECs directly from the X-Celligence system.

<p>The assay was repeated seven times with similar result during 25h observation at 37^°C. The difference between migration curves for cells in cultures with presence of hAM CCM and in control medium was significant. (p < 0.05).</p

Effect of hAM CCM on HUVECs migration assayed by scratch test.

<p>There are results of 160 measurements, 8 independent assays with 10 measurements for test and control each. Median values and (P25, P75) are shown (n = 8, p < 0.05). Detailed description of the assay is in Material and methods.</p

Growth factors in hAM CCM.

<p>Forty-one growth factors were quantitated by antibody array and the obtained values were combined into following growth factor families: EGF family (EGF-2, HB-EGF, EGF-R); FGF family (bFGF, FGF-4, FGF-6, FGF-7); Hematopoietic factors HF (MCSF, MCSF-R, SCF, SCF-R); IGF family (IGF-1, IGF-2, IGF-1SR); IGFBP family (IGFBP-1, IGFBP-2, IGFBP-3, IGFBP-4, IGFBP-6); Neurotrophic factors NF (bNGF, GDNF, NT-3, NT-4); PDGF family (PDGF-AA, PDGF-AB, PDGF-BB, PDGF-Ra, PDGF-Rb); TGF family (TGF-α, TGF-β, TGF-β2, TGF-β3); Vasculogenic factors VF (PLGF, VEGF, VEGF-R3, VEGF-D, VEGF-R2); some growth factors are presented separately: AR; G-CSF; GM-CSF; HGF. Each growth factor fluorescence value (FV) was measured and calculated as described in Materials and methods. (n = 4) (p < 0.05).</p

Effect of hAM CCM on chemotaxy indeks of BM MNCs.

<p>The chemotaxy index (CI) after 2.5 h at 37^°C incubation time was calculated by dividing the number of cells in lower chamber by the number of cells added to the upper chamber counted at the start of the test. Median values and interquartile range (P25, P75) are shown (n = 12, p < 0.05).</p

Effect of hAM CCM on HUVECs expression of cell adhesion molecule-1 (CD31) marker.

<p>Significantly lower expression is observed in presence of hAM CCM. Median values and interquartile ranges (P25, P75) are shown (n = 3, p < 0.05).</p