Protocol for Observational Study of Post op Delirium Following Total Joint Arthroplasties
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ClinicalTrials.gov Identifier: NCT03260218 |
Recruitment Status : Unknown
Verified August 2017 by Singapore General Hospital.
Recruitment status was: Recruiting
First Posted : August 24, 2017
Last Update Posted : August 31, 2017
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Condition or disease |
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Postoperative Delirium |

Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Protocol for a Single-Centre Prospective Observational Study of Postoperative Delirium Following Total Joint Arthroplasties Among South East Asians |
Actual Study Start Date : | July 3, 2017 |
Estimated Primary Completion Date : | December 31, 2017 |
Estimated Study Completion Date : | December 31, 2017 |
- Post operative delirium incidence [ Time Frame: Up to 30 days ]Measured using confusion assessment method (CAM) tool
- Post operative complications [ Time Frame: Up to 30 days post operatively ]measured using post operative morbidity survey (POMS)
- incidence of post operative nausea and vomiting (PONV) [ Time Frame: post op day 1 ]the total number of patients experiencing PONV
- Length of hospital stay [ Time Frame: up to 12 months ]the total number of days stayed in hospital during this elective admission
- Hospital readmission rate [ Time Frame: 30 days post operative ]the percentage of patients being readmitted for a complication related to the surgery
- functional and health-related quality-of-life (HRQoL) [ Time Frame: 6 months , 12 months ]tools used to assess knee function, ADL status, emotional and social wellbeing
- Days Alive and Out of Hospital (DAOH) [ Time Frame: 1 month, 6 months, 12 months ]measures the death rate and total summation of days spent outside of hospital following the surgery

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Ages Eligible for Study: | 65 Years to 90 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients undergoing elective total knee or total hip arthroplasty
Exclusion Criteria:
- Patients who are deemed to lack mental capacity to give consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260218
Contact: Hairil Abdullah, MBBS | 63265519 | hairil.rizal.abdullah@singhealth.com | |
Contact: Hairil Rizal Abdullah, MBBS | 63265519 | hairil.rizal.abdullah@singhealth.com |
Singapore | |
Singapore General Hospital | Recruiting |
Singapore, Singapore, 169608 | |
Principal Investigator: Hairil Rizal Abdullah, MBBS | |
Sub-Investigator: Hamid Razak, MBBS | |
Sub-Investigator: Eileen Sim, MBBS | |
Sub-Investigator: Si Jia Lee, MBBS | |
Sub-Investigator: Rachel Seet, MBBS | |
Sub-Investigator: Ervin Sethi, MBBS |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Singapore General Hospital |
ClinicalTrials.gov Identifier: | NCT03260218 History of Changes |
Other Study ID Numbers: |
TJA2017 |
First Posted: | August 24, 2017 Key Record Dates |
Last Update Posted: | August 31, 2017 |
Last Verified: | August 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
postoperative delirium elderly total joint replacement risk factors for delirium postoperative confusion |
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Neurocognitive Disorders Mental Disorders |