Effect of Surgical Approach on Postoperative Bleeding in... | NCT06308003

Studies
Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty

NCT06308003

Sponsor

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

Status

Unknown status

Last Update Posted

Mar 13, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Hip Arthropathy

Interventions

Anterior hip arthroplasty

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2023Actual

Primary Completion Date

Apr 2025Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

Mar 6, 2024

First Submission Date that Met QC Criteria

Mar 6, 2024

First Posted Date

Mar 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2024

Last Update Posted Date

Mar 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anterior hip arthroplasty	Procedure	Anterior hip arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients who will undergo surgery of hip arthroplasty

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elena Cittera	Contact	0283502224		elena.cittera@grupposandonato.it

Overall Officials

Name	Affiliation	Role
Alberto Ventura	Ospedale Galeazzi-Sant'Ambrogio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Clinico San Siro	Recruiting	Milan			Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided