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NCT06308003 Clinical Trial

Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty

Hip Arthropathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06308003
Other study ID # PTA CONF
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 13, 2023
Est. completion date September 2025

Study information
Verified date March 2024
Source I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Contact Elena Cittera
Phone 0283502224
Email elena.cittera@grupposandonato.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date September 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Anterior hip arthroplasty
Anterior hip arthroplasty

Locations
Country Name City State
Italy Istituto Clinico San Siro Milan

Sponsors (1)
Lead Sponsor Collaborator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on 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
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