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Iron Supplementation in Hip/Knee Surgery

Primary Purpose

Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sucrosomial iron plus ascorbic acid
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IRCCS Istituto Ortopedico Galeazzi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (group A)

Control (group B)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 2, 2019
Last Updated
May 8, 2023
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT04078880
Brief Title
Iron Supplementation in Hip/Knee Surgery
Official Title
Sideral Forte in Prosthetic Hip and Knee Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
September 16, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy, Anemia, Iron Poor Blood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (group A)
Arm Type
Experimental
Arm Description
Patients who are subjected to the intervention, being iron plus ascorbic acid, other than the standard of care.
Arm Title
Control (group B)
Arm Type
No Intervention
Arm Description
Patients who are not subjected to the intervention and follow the standard of care.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucrosomial iron plus ascorbic acid
Intervention Description
A number of 41 subjects are supplemented with 30 mg of iron plus 70 mg of ascorbic acid daily for 30+/-5 days before orthopedic surgery.
Primary Outcome Measure Information:
Title
Change of blood hemoglobin levels
Description
CHange of hemoglobin concentration (g/dl) from baseline and after 30 days +/- 5 days
Time Frame
Baseline and 30 days +/- 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Perazzo
Organizational Affiliation
IRCCS Istituto Ortopedico Galeazzi
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Iron Supplementation in Hip/Knee Surgery

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