Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty

NCT06308003 | Recruiting

• 1 other identifier: PTA CONF
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthropathy

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Anterior hip arthroplasty PROCEDURE

Anterior hip arthroplasty

Eligibility Criteria

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

Study Population

adult patients who will undergo surgery of hip arthroplasty

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Istituto Clinico San Siro

Milan, Italy

RECRUITING

Study Officials

• Alberto Ventura

  Ospedale Galeazzi-Sant'Ambrogio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Cittera

CONTACT

0283502224; elena.cittera@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: February 13, 2023
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

IT (1)