A prospective, observational study to assess the functional recovery, duration of hospital stays, and complications of patients undergoing Robot assisted Total Hip Replacement surgery
Recruiting
- Conditions
- Osteoarthritis of hip, unspecified,
- Registration Number
- CTRI/2020/11/029049
- Lead Sponsor
- Anup Institute of Orthopedics and Rehabilitation
- Brief Summary
This prospective, observational, Investigator Initiated study will be conducted at a study site under the Principal Investigator. The study aims to assess the functional outcomes and complications of patients undergoing robotic Total Hip replacement
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 1.Patients undergoing total hip arthroplasty.
- 2.Male and female aged 20 years and above (with fusion of capital epiphysis) 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 hip 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 THA 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 THA Baseline, 5 days post op, 6 week, 3 and 6 month, 1,2,3 and 5 year
- Secondary Outcome Measures
Name Time Method 1. Changes in pain levels as reported by patients between pre-operation (baseline) and post-operation during the course of the study (before discharge and post-surgery 2. Total 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, IndiaDr Ashish SinghPrincipal investigator8294240349drashishsingh@hotmail.com