Iron Supplementation in Hip/Knee Surgery

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Completed

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

Treatments: Dietary Supplement: Sucrosomial iron plus ascorbic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04078880

L2039 (Other Grant/Funding Number)

Sideral (PI: P Perazzo)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

Intervention (group A)

Experimental group

Description:

Patients who are subjected to the intervention, being iron plus ascorbic acid, other than the standard of care.

Treatment:

Dietary Supplement: Sucrosomial iron plus ascorbic acid

Control (group B)

No Intervention group

Description:

Patients who are not subjected to the intervention and follow the standard of care.