The Influence of Perioperative Strategies on the Extent of in Orthopaedic Prosthetic Surgery

NCT07500350 | Not Yet Recruiting

• 1 other identifier: IPECO
• Study Type: observational
• Target: 1,683
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthopaedic Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

The sample size was calculated by considering the decline in haemoglobin from pre- operative to day

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may not qualify if:

• Reoperation, as bleeding depends on a variable that is not constant, namely the initial implant

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Milan, Milan, Italy

Location

Study Officials

• Giorgio Oriani, P.I.

  IRCCS Laleazzi Sant Ambrogio Site San Siro Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Oriani, Principal Investigator

CONTACT

+39335225452; gorian@alice.it

Georges Ghanem, Chief of Anesthetic Dept

CONTACT

+39-2-48785206; georges.ghanem@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Giorgio Oriani

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: March 2026 to March 2028
• Access Criteria: collecting parameters and analyzing data. Contact Statystical group with me

Locations

IT (1)