Post-operative Anemia in Lateral Fractures of the Femur.

Completed

• Conditions: Femur Fracture
• Interventions: Diagnostic Test: hemoglobin serum value

• Registration Number: NCT05225753
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2021-12
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-02-01
• Last Update Submitted: 2022-02-01
• Study First Posted: 2022-02-07
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients treated with EBA2 Citieffe	hemoglobin serum value	-
patients treated with Affixus Zimmer-Biomet	hemoglobin serum value	-
patients treated with Proximal Femoral Nail Antirotation Synthes	hemoglobin serum value	-

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin serum value	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).

Trial Locations

Locations (1)

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia; 🇮🇹 Bari, Italy