IRCCS Orthopaedic Institute Galeazzi

Milano, Italy

IRCCS Orthopaedic Institute Galeazzi

Milano, Italy
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Gianola S.,University of Milan Bicocca | Gianola S.,IRCCS Orthopaedic Institute Galeazzi | Frigerio P.,Child and Adolescent Neuropsychiatric Unit | Agostini M.,Kinematics and Robotics Laboratory | And 15 more authors.
Physiotherapy Canada | Year: 2016

Purpose: To assess reporting completeness of the most frequent outcome measures used in randomized controlled trials (RCTs) of rehabilitation interventions for mechanical low back pain. Methods: We performed a cross-sectional study of RCTs included in all Cochrane systematic reviews (SRs) published up to May 2013. Two authors independently evaluated the type and frequency of each outcome measure reported, the methods used to measure outcomes, the completeness of outcome reporting using a eight-item checklist, and the proportion of outcomes fully replicable by an independent assessor. Results: Our literature search identified 11 SRs, including 185 RCTs. Thirty-six different outcomes were investigated across all RCTs. The 2 most commonly reported outcomes were pain (n = 165 RCTs; 89.2%) and disability (n = 118 RCTs; 63.8%), which were assessed by 66 and 44 measurement tools, respectively. Pain and disability outcomes were found replicable in only 10.3% (n = 17) and 10.2% (n = 12) of the RCTs, respectively. Only 40 RCTs (21.6%) distinguished between primary and secondary outcomes. Conclusions: A large number of outcome measures and a myriad of measurement instruments were used across all RCTs. The reporting was largely incomplete, suggesting an opportunity for a standardized approach to reporting in rehabilitation science. © University of Toronto Press Inc. All rights reserved.


Romano C.L.,IRCCS Orthopaedic Institute Galeazzi | Monti L.,IRCCS Orthopaedic Institute Galeazzi | Logoluso N.,IRCCS Orthopaedic Institute Galeazzi | Romano D.,IRCCS Orthopaedic Institute Galeazzi | Drago L.,IRCCS Orthopedic Institute Galeazzi
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2015

Purpose: The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery. Methods: This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient’s group allocation. Results: Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0–4) vs. 1.9 ± 1.41 (range 0–5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study. Conclusions: This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery. Clinical relevance: A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery. Level of evidence: II. © 2014, Springer-Verlag Berlin Heidelberg.


PubMed | IRCCS Orthopedic Institute Galeazzi and IRCCS Orthopaedic Institute Galeazzi
Type: Journal Article | Journal: Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA | Year: 2015

The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery.This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patients group allocation.Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 1.13 (range 0-4) vs. 1.9 1.41 (range 0-5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study.This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery.A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery.II.

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