Iron Supplementation in Hip/Knee Surgery

Not Applicable

Completed

• Conditions: Anemia; Iron Poor Blood; Orthopedic Disorder; Knee Arthropathy; Hip Arthropathy
• Interventions: Dietary Supplement: Sucrosomial iron plus ascorbic acid

• 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

Arm && Interventions

Group	Intervention	Description
Intervention (group A)	Sucrosomial iron plus ascorbic acid	Patients who are subjected to the intervention, being iron plus ascorbic acid, other than the standard of care.

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