A prospective, observational study to assess the functional recovery, duration of hospital stay, and complications in patients with arthritis undergoing Robotic Total Knee Replacement surgery
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2020/11/029021
- Lead Sponsor
- Anup Institute of Orthopedics and Rehabilitation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients with ends stage knee arthritis eligible for Total knee arthroplasty.
2.Male and female aged 18 years to 90 years
3.Subject is willing to take part in the study by signing Ethics Committee (EC) approved informed consent form (ICF)
4.Subjects agrees to comply with postoperative scheduled clinical and radiographic evaluation
1.Patient with an active infection within the affected knee joint
2.Patient with neuromuscular or neurosensory deficiency that may affect the ability to evaluate the study end points.
3.Patients who are known drug or alcohol abusers or with psychological disorders that could affect follow up care or treatment outcomes.
4.Patients with history of deep vein thrombosis or other thrombotic disorders.
5.Patients for whom the surgical procedure is a revision of a previous TKA or hemi arthoplasty, or who have previously undergone arthrodesis or osteotomy of the knee.
6.Clinical signs of a coexisting severe acute systemic illness (Pneumonia, sepsis, UTI, other co-morbidities)
7.Diagnosis of immune deficiency (AIDS, other congenital
immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc.)
8.Participation in another clinical study within 30 days before the beginning or anytime during the duration of the current clinical study.
9.Patient is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
10.Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
11.Patient identified as employee of the Investigator or study center as well as family members (i.e. immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To observe the functional recovery, duration of hospital stay and complications of Robotic assisted technology in patients undergoing TKATimepoint: Baseline, 5 days post surgery, 6 weeks, 3 month, 6 month, 1 year, 2 year, 3 year and 5 year
- Secondary Outcome Measures
Name Time Method Changes in pain levels between pre-operation (baseline) and post-operation during the course of the study (before discharge and post-surgery <br/ ><br>Total time taken for surgery <br/ ><br>Amount of blood loss during surgery <br/ ><br>Bone measurements- Anthropometry, Post bone cut extension gap difference in Minimally invasive surgery. <br/ ><br>Patients requiring spinal vs general anesthesia <br/ ><br>Patients diagnosed with Deep vein thrombosis (DVT) <br/ ><br>Patients with infections despite Antibiotic prophylaxis <br/ ><br>Implant defects <br/ ><br>Timepoint: One, two, three and five years