Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty

March 6, 2024 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Effect of Surgical Approach on Postoperative Bleeding in Patients Undergoing Hip Arthroplasty: Anterior Vs. Posterolateral Route

The study is, in accordance with current legislation, definable as monocentric Prospective Observational.

The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.

adult patients who will undergo surgery of hip arthroplasty.

Patients will undergo:

Preoperative T0: clinical visit/medical history, completion of the VAS questionnaire, Blood sampling to assess hemoglobin values Operative T1: hip arthroplasty surgery using one of the surgical approaches routinely used within our Institute T2 - Postoperative at 1 day from T1: VAS questionnaire, evaluation of any Adverse events T3 - Postoperative at 3 days from T1: blood loss based on the values of hemoglobin (Hb), assessment of any adverse events, and VAS questionnaire T4- Post operative at 45 days +/- 10 days from T1: evaluation of any events adverse, follow-up visit.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The presence of bleeding and pain after prosthesis surgery Hip injuries can affect the patient's condition in the postoperative period increasing the length of hospital stay and slowing down the rehabilitation process.

It is hypothesized that there are differences in terms of postoperative bleeding, Postoperative pain and hospital stay time between different approaches surgical procedures in the treatment of hip osteoarthritis with arthroprosthesis. The adoption of a Surgical approach that can reduce bleeding and pain could reduce the length of hospital stay in patients undergoing hip arthroplasty.

The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.

Secondary objectives are postoperative pain assessment with questionnaire VAS and length of hospital stay according to surgical approach used (anterior Vs. posterolateral route). Also evaluate Any adverse events.

Adult patients who will undergo surgery of hip arthroplasty.

The inclusion criteria are:

  • adult patients with coxarthrosis who are candidates for surgery hip arthroplasty
  • Signing of the Informed Consent and consent to collaborate in all study procedures.

The exclusion criteria are:

  • Minors
  • Pregnant women (self-declaration)
  • patients with BMI ≥ 30
  • Non-acceptance of informed consent
  • Patients with prior unilateral hip reconstructive surgery or Contralateral

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • Istituto Clinico San Siro
        • Contact:
        • Principal Investigator:
          • Alberto Ventura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

adult patients who will undergo surgery of hip arthroplasty

Description

Inclusion Criteria:

  • adult patients with coxarthrosis who are candidates for surgery hip arthroplasty
  • Signing of the Informed Consent and consent to collaborate in all study procedures.

Exclusion Criteria:

  • Minors
  • Pregnant women (self-declaration)
  • patients with BMI ≥ 30
  • Non-acceptance of informed consent
  • Patients with prior unilateral hip reconstructive surgery or Contralateral

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
Time Frame: the third postoperative day
The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.
the third postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Alberto Ventura, Ospedale Galeazzi-Sant'Ambrogio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTA CONF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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