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

A prospective, observational study to assess the functional recovery, duration of hospital stays, and complications of Robot assisted Total Hip Replacement surgery in patients 20 years and above (with fusion of capital epiphysis) in India â?? A pilot investigator initiated study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/11/029049
Enrollment
100
Registered
2020-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M169- Osteoarthritis of hip, unspecified

Interventions

None listed

Sponsors

Anup Institute of Orthopedics and Rehabilitation
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 3. Amount of blood loss during surgery 4. Bone measurements 5. Patients requiring spinal vs general anesthesia 6. Patients diagnosed with Deep vein thrombosis 7. Patients with infections despite Antibiotic prophylaxis 9. Implant defects Timepoint: one, two, three and five years

Countries

India

Contacts

Public ContactDr Ashish Singh

Anup Institute of Orthopedics and Rehabilitation

drashishsingh@hotmail.com8294240349

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026