An observational study in Orthopaedic Surgery, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational
To assess the extent of blood loss in prosthetic surgery, considering whether possible variables may influence, either positively or negatively, the extent of such loss. The assessment will be carried out by analysing parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.
Numerous clinical studies have examined blood loss - both intraoperative and, above all, total blood loss - in shoulder, hip and knee replacement surgery.
Anaesthetic and surgical techniques, relevant medications, the use of pneumatic tourniquets and, more simply, intraoperative positioning, as well as blood-sparing and blood recovery methods, have been the subject of extensive literature. Our study aims to retrospectively evaluate a full year of prosthetic surgery, analysing all the factors involved in the search for a definitive answer regarding the best method for this purpose, if feasible [1,2,3,4,5].
Prior to admission, the patient undergoes a standardised series of tests, which also include a complete blood count, serum iron, transferrin and ferritin levels.
This series of tests concerning haematocrit and haematopoietic function is then repeated on the 1st, 3rd and 7th post-operative days to assess overall blood loss
. Patients of both sexes who have undergone total knee replacement (unilateral or bilateral), unicompartmental and total knee replacement (unilateral or bilateral), and total shoulder replacement.
The above patients operated on between January 2025 and December 2025 at the San Siro Clinic.
3.1 General objective To assess the extent of blood loss in prosthetic surgery, considering whether possible variables may influence, either positively or negatively, the extent of such loss. The primary objective is to evaluate the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative methods used.
The assessment will be carried out by analysing the parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.
3.2 Primary objective The primary objective is to assess the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative techniques used.
The assessment will be carried out by analysing the parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.
3.3 Secondary objectives
Transfusion of blood or blood products: to be considered a 'relative failure' in preoperative preparation and/or the perioperative course
4. STUDY DESIGN This is a retrospective, observational, single-centre study involving patients who underwent orthopaedic prosthetic surgery (hip, knee and shoulder) at the IRCCS Istituto Clinico San Siro between January 2025 and December 2025, with clinical data collection. The study will be conducted in accordance with Good Clinical Practice guidelines.
Patients of both sexes who have undergone total knee replacement (unilateral or bilateral), unicompartmental and total knee replacement (unilateral or bilateral), and total shoulder replacement.
- Adult patients in ASA Class I-II-III undergoing prosthetic surgery, as a first-time implant
Exclusion criteria:
The sample size was calculated by considering the decline in haemoglobin from pre- operative to day 5 as the primary outcome of the study and planning to use a multiple linear regression model. We assume we wish to test the additional contribution of 4 further predictors indicating the type of technique used (Local Infiltration of Anaesthetics (LIA), application of an intraoperative pneumatic tourniquet, intraoperative recovery of blood loss, application of drainage) to an initial regression model that includes sex, age, ASAC risk class, and antiplatelet or anticoagulant therapy. The complete model therefore includes 8 regression coefficients. We wish to test whether adding these 4 predictors to the initial model results in an increase of at least 1% in the variance explained by the model. Considering a significance level (alpha) of 5% and a power of 90%, the required sample size is 1530.
The primary objective is to assess the extent and variability of blood loss in comparison with the literature and in relation to the various intraoperative techniques used. The assessment will be carried out by analysing the parameters (haemoglobin - hae
A likelihood ratio test will also be performed to assess whether the full model performs better in terms of explained variance compared to the initial model including sex, age, ASAC risk class, and antiplatelet or anticoagulant therapy. Furthermore, all model coefficients will be evaluated individually and together with their 95% confidence intervals to assess the presence of statistically differences between the various surgical techniques.
Time frame: 6 months
Plan to share: Yes — Dr. Claudio Legnani is an Orthopaedic physician well involv ed in this field, and I want to take part with another expert
Supporting information: Study protocol, Csr
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