Post-operative Anemia in Lateral Fractures of the Femur.

NCT05225753 | Completed

• 1 other identifier: Post-op Anemia
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Femur Fracture

Keywords

fragility lateral femoral fractures; intramedullary nail; Post-operative anemia; surgical time; Blood transfusions number

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

patients treated with Affixus Zimmer-Biomet

Diagnostic Test: hemoglobin serum value

patients treated with EBA2 Citieffe

Diagnostic Test: hemoglobin serum value

patients treated with Proximal Femoral Nail Antirotation Synthes

Diagnostic Test: hemoglobin serum value

Interventions

hemoglobin serum value DIAGNOSTIC_TEST

post-operative anemia evaluated with hemoglobin serum value

patients treated with Affixus Zimmer-Biomet; patients treated with EBA2 Citieffe; patients treated with Proximal Femoral Nail Antirotation Synthes

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead
• Ospedali Riuniti di Foggia: collaborator

Study Sites (1)

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 7, 2022
• Study Start: November 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 7, 2022

Record last verified: 2021-12

Locations

IT (1)