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(Study comparing the rate of hypophosphatemia and side effect when using Preoperative Ferric Carboxymaltose (FCM) vs Iron isomaltoside in unilateral Total Knee Arthroplasty: Randomized controlled trial)

(Study comparing the rate of hypophosphatemia and side effect when using Preoperative Ferric Carboxymaltose (FCM) vs Iron isomaltoside in unilateral Total Knee Arthroplasty: Randomized controlled trial)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009011
Enrollment
104
Registered
2023-12-04
Start date
2023-12-04
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In this study, we plan to enroll patients aged 60 and above who are scheduled to undergo unilateral staged total knee arthroplasty and have confirmed preoperative anemia (hemoglobin levels of 8

Sponsors

Bundang CHA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing unilateral total knee arthroplasty Aged 60 years or older Patients with confirmed anemia in preoperative blood tests (hemoglobin levels for male patients between 8g/dL and 13g/dL, and for female patients between 8g/dL and 12g/dL)

Exclusion criteria

Exclusion criteria: - First operation Preop Hb 2xUNL) - Systemic inflammatory diseases - Use of iron supplements within 4 weeks - Intravenous iron, or erythropoietin within 4 weeks - Preoperative use of anticoagulant (warfarin, factor Xa inhibitor) - Coagulopathy - Chronic renal failure - Patients with hypersensitivity to this drug or its components - Patients with known significant hyperalgesia to other parenteral iron preparations - Patients with excessive iron or iron use disorder - Patients with liver dysfunction - Patients with acute or chronic infections (In cases of chronic infection, assessment of benefits and risks should be performed in consideration of red blood cell generation inhibition) - Patients with asthma, eczema, atopic allergies and with their past medical history - allergic patients including drug allergy - Pregnant woman - Patients weighing less than 35 kg - Patients with surgical side effect associated with bleeding (If all the procedures are completed and there is uncontrolled bleeding after decompressing the torniquet prior to skin suture, bleeding related complications will be considered to have occurred.)

Design outcomes

Primary

MeasureTime frame
Frequency of postoperative hypophosphatemia—

Secondary

MeasureTime frame
hemoglobin—

Countries

Korea, Republic of

Contacts

Public ContactJae-Young Park

Bundang CHA General Hospital

neoxcv@gmail.com+82-2-5555-5555

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026