TO COMPARE TWO TECHNIQUES OF TOTAL KNEE REPLACEMENT WITH RESPECT TO AFFECT ON HEART AND LUNGS

A PROSPECTIVE RANDOMIZED STUDY TO COMPARE THE SYSTEMIC EMBOLI IN COMPUTER ASSISTED NAVIGATION VS CONVENTIONAL SURGICAL TECHNIQUE OF KNEE REPLACEMENT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/01/004291

Enrollment

Registered

2014-01-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients undergoing total knee replacement

Interventions

Intervention1: Computer assisted navigation total knee replacement surgery: Both femoral and tibial bone cuts are computer assisted and femoral and tibial intramedullary canal not breached during tota

Eligibility

Inclusion criteria

Inclusion criteria: Adult patient with sufficient knee pathology to be appropriate candidate for Total knee replacement falling in ASA 1 and 2 groups.

Exclusion criteria

Exclusion criteria: 1. Simultaneous hip and knee arthroplasty 2. Simultaneous bilateral TKR 3. Morbid obesity BMI > 40 4. Esophageal disease 5. History of DVT/ PE/ prolonged immobilization 6. Patients requiring a tibial / femoral stem 7. Refusal to give consent 8. Patients done under regional anesthesia 9. Patients having any bleeding diathesis or on anticoagulants 10. Patients suffering from renal disease precluding the use of enoxaparin

Design outcomes

Primary

Measure	Time frame
1. Embolus burden quantified by TEE at time of intramedullary rod insertion and after tourniquet release 2. Relation of embolic showers with pulmonary artery wedge pressure 3. Bone marrow/ fat/ thrombus/ air/ cement components in blood samples 4. Measured and hidden Blood loss 5. Operating time Timepoint: 1. At baseline 2. After bone cuts 3. After trial 4. After cementing 5. After tourniquet release	—

Measure

Time frame

1. Embolus burden quantified by TEE at time of intramedullary rod insertion and after tourniquet release 2. Relation of embolic showers with pulmonary artery wedge pressure 3. Bone marrow/ fat/ thrombus/ air/ cement components in blood samples 4. Measured and hidden Blood loss 5. Operating time Timepoint: 1. At baseline 2. After bone cuts 3. After trial 4. After cementing 5. After tourniquet release

—

Secondary

Measure	Time frame
1. Relation of embolic showers with pulmonary artery wedge pressure 2. Bone marrow/ fat/ thrombus/ air/ cement components in blood samples 3. Measured and hidden Blood loss 4. Operating time Timepoint: At baseline 2. After bone cuts 3. After trial 4. After cementing 5. After tourniquet release	—

Countries

India

Contacts

Public ContactDr Amit Singla

All India Institute of Medical Sciences, New Delhi

rmalhotra62@gmail.com01126593589

Outcome results

None listed

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