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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

Recruiting
Conditions
Osteoarthritis of knee, unspecified,
Registration Number
CTRI/2020/11/029021
Lead Sponsor
Anup Institute of Orthopedics and Rehabilitation
Brief Summary

This prospective, observational, Investigator Initiatedstudy will be conducted at a study sites under the Principal Investigator.

 Patients between the agesof 18 to 90 years, presenting with end stage knee arthritis requiring TotalKnee Arthroplasty (TKA) in the Outpatient Department (OPD) of the investigatorwill be considered for the study.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
50
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
NameTimeMethod
To observe the functional recovery, duration of hospital stay and complications of Robotic assisted technology in patients undergoing TKABaseline, 5 days post surgery, 6 weeks, 3 month, 6 month, 1 year, 2 year, 3 year and 5 year
Secondary Outcome Measures
NameTimeMethod
Changes in pain levels between pre-operation (baseline) and post-operation during the course of the study (before discharge and post-surgeryTotal time taken for surgery

Trial Locations

Locations (1)

Anup Institute of Orthopedics and Rehabilitation

🇮🇳

Patna, BIHAR, India

Anup Institute of Orthopedics and Rehabilitation
🇮🇳Patna, BIHAR, India
Dr Ashish Singh
Principal investigator
8294240349
drashishsingh@hotmail.com

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