Post-operative Anemia in Lateral Fractures of the Femur.

Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225753
• Other study ID #: Post-op Anemia
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2021
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Anemia
• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Diagnostic Test:
• hemoglobin serum value
post-operative anemia evaluated with hemoglobin serum value

Locations

Country	Name	City	State
Italy	AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia	Bari

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	Ospedali Riuniti di Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin serum value	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)