Iron Supplementation in Hip/Knee Surgery

Not Applicable

Completed

• Conditions: Anemia; Iron Poor Blood; Orthopedic Disorder; Knee Arthropathy; Hip Arthropathy

• Registration Number: NCT04078880
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

Randomized controlled trial to evaluate the efficacy of oral iron supplementation in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-04
• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-06
• Primary Completion: 2019-09-16
• Study Completion: 2020-01-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Males and females
• ASA 1, 2, or 3
• No neuropsychiatric conditions
• Acceptance of informed consent
• Elective prosthetic hip or knee surgery

Exclusion Criteria

• ASA 4
• Present or past neuropsychiatric conditions
• Hip or knee revision surgery
• Use of iron as dietary supplement
• Known erythrocytosis
• Incompatible hypersensitivities
• Iron metabolism disorders
• Lymphoproliferative disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of blood hemoglobin levels	Baseline and 30 days +/- 5 days	CHange of hemoglobin concentration (g/dl) from baseline and after 30 days +/- 5 days

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milan, Italy