Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty

Recruiting

• Conditions: Hip Arthropathy

• Registration Number: NCT06308003
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

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.

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 Timeline

• Study Start: 2023-02-13
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Last Update Submitted: 2024-03-06
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Primary Completion: 2025-04
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Istituto Clinico San Siro; 🇮🇹 Milan, Italy