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

Not yet recruiting

Brief Summary: | |

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|The patients planned for single implant TKA at the study centre shall be approached for the study. If they agree to participate and sign the informed consent form, data shall be collected for the study variables at the following time points, Pre-operative, Post-operative at 6 weeks, 3 months, 1 year and 2 years after surgery.

This shall be a single surgeon series from the study centre. The surgeon shall record the planned bone resections after initial bone mapping. A navigated probe shall be used to determine bone resection of the distal femur, anterior femur, and tibia after bone resection. Computer measurement of bone resection shall be recorded. Coronal alignment shall be recorded at trial implantation and definitive implantation. Data shall be recorded in real-time as screenshots of the MAKO system software and stored for analysis. Post-op CT shall be done for all patients.

Data for accuracy of measurements and tibial rotation shall be collected from pre-op, intra-op and post-op medical records.

WOMAC and KSS shall be administered pre-op and post-op at 6 weeks, 3 months, 1 year and 2 years.

FJS shall be administered post-op at 6 weeks, 3 months, 1 year and 2 years.

Recruitment & Eligibility

Inclusion Criteria

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

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.

Primary Outcome Measures

Name	Time	Method
ii)To measure the tibial component rotation.	Screening. Post-op Day 1, Week 6, Month 3 and year 1 and 2
i)To evaluate the accuracy of bone resection by the MAKO software.	Screening. Post-op Day 1, Week 6, Month 3 and year 1 and 2
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.	Screening. Post-op Day 1, Week 6, Month 3 and year 1 and 2

Secondary Outcome Measures

Name	Time	Method

Locations (1): Anup Institute of Orthopedics and Rehabilitation
🇮🇳
Patna, BIHAR, India
Anup Institute of Orthopedics and Rehabilitation
🇮🇳Patna, BIHAR, India
Dr Shashank Varma
Principal investigator
8800547149
drshashankvarma04@gmail.com