Post-operative Anemia in Lateral Fractures of the Femur.

February 1, 2022 updated by: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Post-operative Anemia in Lateral Fragility Fractures of the Femur. A Prospective Observational Study in Three Different Intramedullary Nails

It was conducted a prospective study with a series of 45 patients with lateral fragility fractures of the femur treated by three different intramedullary nails. Patients were randomized in Group A (15 patients treated by Affixus Zimmer-Biomet), Group B (15 patients treated by EBA2 - Citieffe) and Group C (15 patients treated by Proximal Femoral Nail Antirotation Synthes).

One independent observer performed seven biochemical evaluations (hemoglobin serum value) from admission to patient discharge. Surgical time and Blood transfusions number were reported for each partecipant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Fortyfive (45) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between November 2020 and September 2021 with lateral fragility fracture were prospectively recruited.

Description

Inclusion Criteria:

  • femur fractures type 31-A1, A2, A3 (Muller ME, Nazarian S, Kock P et al.);
  • age more than 65 years;

Exclusion Criteria:

  • patients with neurological diseases;
  • finding of anemia before surgery;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients treated with Affixus Zimmer-Biomet
Diagnostic test: hemoglobin serum value
post-operative anemia evaluated with hemoglobin serum value
patients treated with EBA2 Citieffe
Diagnostic test: hemoglobin serum value
post-operative anemia evaluated with hemoglobin serum value
patients treated with Proximal Femoral Nail Antirotation Synthes
Diagnostic test: hemoglobin serum value
post-operative anemia evaluated with hemoglobin serum value

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hemoglobin serum value
Time Frame: Preoperative, Day 0, Day 1, Day 2, Day 3, Day 5 (after surgery)
Post-operative anemia was quantified using the hemoglobin serum value ranging between more than 10 g/dl (no post-operative anemia) and less than 10 g/dl (post-operative anemia).
Preoperative, Day 0, Day 1, Day 2, Day 3, Day 5 (after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Collaborators

Ospedali Riuniti di Foggia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ACTUAL)

September 1, 2021

Study Completion (ACTUAL)

September 1, 2021

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (ACTUAL)

February 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Post-op Anemia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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