A prospective, observational study to assess the functional recovery, duration of hospital stays, and complications of patients undergoing Robot assisted Total Hip Replacement surgery

Not Applicable

Conditions: Health Condition 1: M169- Osteoarthritis of hip, unspecified

Registration Number: CTRI/2020/11/029049

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

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 THATimepoint: 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 <br/ ><br>2. Total time taken for surgery <br/ ><br>3. Amount of blood loss during surgery <br/ ><br>4. Bone measurements <br/ ><br>5. Patients requiring spinal vs general anesthesia <br/ ><br>6. Patients diagnosed with Deep vein thrombosis <br/ ><br>7. Patients with infections despite Antibiotic prophylaxis <br/ ><br>9. Implant defects <br/ ><br>Timepoint: one, two, three and five years