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A study to check the correctness of bone cuts and rotation of tibia in patients undergoing robot assisted total knee replacement

Prospective study to evaluate the accuracy of bone resection of MAKO TKA and measurement of tibial component rotation CT based with short term functional outcome.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/07/043767
Enrollment
100
Registered
2022-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: M255- Pain in joint

Interventions

Sponsors

Anup Institute of Orthopedics and Rehabilitation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All primary Osteoarthritis (OA) knee, Rheumatoid arthritis (RA) knee / Post-Traumatic Osteoarthritis undergoing Single implant â?? Stryker triathlon using MAKO Robotic system 2. Male and females aged 21 years to 85 years (inclusive) 3. Subject is willing to take part in the study by signing Ethics Committee (EC) approved informed consent form (ICF) 4. Subject agrees to comply with postoperative scheduled clinical and radiographic evaluation

Exclusion criteria

Exclusion criteria: 1. Revision TKA 2. Using constraint knee 3. Knee with tumours, infection 4. Patients shall be excluded from the study if their data is not captured by the computer software 5. Patient with a neuromuscular or neurosensory deficiency that may affect the ability to evaluate the study endpoints. 6. Patients who are known drug or alcohol abusers or with psychological disorders that could affect follow up care or treatment outcomes. 7. Patients with a history of deep vein thrombosis or other thrombotic disorders. 8. Clinical signs of a coexisting severe acute systemic illness (Pneumonia, sepsis, UTI, other co-morbidities) 9. Diagnosis of immune deficiency (AIDS, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc.) 10. Patient is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study. 11. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.

Design outcomes

Primary

MeasureTime frame
i) To evaluate the accuracy of bone resection by the MAKO software. ii) To measure the tibial component rotation. iii) To evaluate the functional outcome at the end of 2 years using patient-reported outcomes and correlate with the accuracy of bone resections and tibial component rotation. Timepoint: Screening. Post-op Day 1, Week 6, Month 3 and year 1 and 2

Secondary

MeasureTime frame
NoneTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Ashish Singh

Anup Institute of Orthopedics and Rehabilitation

drashishsingh@hotmail.com8294240349

Outcome results

None listed

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