Post-operative Anemia in Lateral Fractures of the Femur.

NCT ID: NCT05225753

Last Updated: 2022-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Femur Fracture

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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patients treated with Affixus Zimmer-Biomet

hemoglobin serum value

Intervention Type DIAGNOSTIC_TEST

post-operative anemia evaluated with hemoglobin serum value

patients treated with EBA2 Citieffe

hemoglobin serum value

Intervention Type DIAGNOSTIC_TEST

post-operative anemia evaluated with hemoglobin serum value

patients treated with Proximal Femoral Nail Antirotation Synthes

hemoglobin serum value

Intervention Type DIAGNOSTIC_TEST

post-operative anemia evaluated with hemoglobin serum value

Interventions

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hemoglobin serum value

post-operative anemia evaluated with hemoglobin serum value

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedali Riuniti di Foggia

OTHER

Sponsor Role collaborator

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Post-op Anemia

Identifier Type: -

Identifier Source: org_study_id

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