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Completed

NCT Number: NCT05225753

Post-operative Anemia in Lateral Fractures of the Femur.

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.

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Key information

Conditions

Femur Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

hemoglobin serum value

Diagnostic Test

post-operative anemia evaluated with hemoglobin serum value

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Collaborators

  • Ospedali Riuniti di Foggia

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2022
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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