Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty

NCT ID: NCT06308003

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-13

Study Completion Date

2025-09-30

Brief Summary

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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

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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

Conditions

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Hip Arthropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Anterior hip arthroplasty

Anterior hip arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alberto Ventura

Role: PRINCIPAL_INVESTIGATOR

Ospedale Galeazzi-Sant'Ambrogio

Locations

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Istituto Clinico San Siro

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elena Cittera

Role: CONTACT

0283502224

Facility Contacts

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Elena Cittera

Role: primary

0283502224

Other Identifiers

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PTA CONF

Identifier Type: -

Identifier Source: org_study_id

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