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Randomised control trial comparing haemostatic effect of Oxidised Regenerated Cellulose versus Intravenous Tranexamic Acid in Total Knee Arthroplasty

Haemostatic effect of Oxidised Regenerated Cellulose versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Randomised Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079383
Enrollment
108
Registered
2025-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: Oxidised Regenerated Cellulose: 2 sheets of Oxidised Regenerated Cellulose 5.1 x 7.6 cm intraarticularly prior to closure intraoperatively Control Intervention1: Tranexamic acid: 15mg/k

Sponsors

Aritra Chattopadhyay
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing bilateral total knee arthroplasty for bilateral primary osteoarthritis of knee

Exclusion criteria

Exclusion criteria: 1. Preoperative anaemia 2. Inflammatory arthritis 3. Arterial or venous thromboembolic diseases 4. Cerebrovascular diseases; hepatic, renal, cardiac dysfunction 5. Genu varum, genu valgum or flexion contracture greater than thirty degrees 6. Congenital or acquired coagulation disorders 7. Intra-op complications

Design outcomes

Primary

MeasureTime frame
Total Blood lossTimepoint: Postop day3—

Secondary

MeasureTime frame
Intraoperative Blood lossTimepoint: Calculated immediately after surgery is finished;Hidden Blood lossTimepoint: Postop day 3;Drain outputTimepoint: Postop day 3;KOOS-JR scoreTimepoint: 2 and 6 weeks followup;Knee Range of MotionTimepoint: 2 and 6 weeks followup;ESR,CRP,Fibrinogen,D-dimer,PT/INRTimepoint: Preoperatively and at postop day 1 and 3;Reported complication/readmissionTimepoint: 6 weeks followup;Surgical timeTimepoint: Calculated immediately after surgery is finished—

Countries

India

Contacts

Public ContactAritra Chattopadhyay

AIIMS Rishikesh

roop.orth@aiimsrishikesh.edu.in8518881790

Outcome results

None listed

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