Sponsor study identifier
observational
6,000
1 country
1
Study Start
September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study will establish total joint arthroplasty registry database in Kaohsiung Chang Gung Memorial Hospital and collect patient-reported outcome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2020
Actual (reported)July 21, 2020
Actual (reported)September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
PROMIS Global--10 Score
Enrolled subjects with total joint arthroplasty of hip and knee will be asked to complete an on-line (web-based) survey (PROMIS-10 global) using a computer. Most patients will only be asked to complete this survey over a maximum 3 year period. The PROMIS-10 Global consists of ten items that measure global physical health (GPH) and general mental health (GMH). The raw PROMIS scores are continuous and range from 4-20. The GPH and GMH scores are converted based on a T-Score Metric allowing for comparisons to a general population. A higher score indicates a better general health
From the pre-operative assessment until 3 years after the srugery
Hip disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR)
The HOOS, JR is a 6-item instrument that includes 2 of the 5 subscales from the original HOOS (pain, and function and daily living). In the HOOS, JR questionnaire, pain is assessed by 2 items; and function and daily living is assessed by 4 items. These items were assigned a score 0-4 based on the options to the questions (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme). A raw score is summed from the 6 items with a minimum score of 0 and a maximum score of 24. High subscale and raw scores represent worse signs and symptoms. Subsequently, the raw summed score is converted to an interval score out of 100, where 0 represents total hip disability and 100 represents perfect hip health. Using the process, a HOOS, JR score was calculated for each patient included in our study from the original HOOS survey.
From the pre-operative assessment until 3 years after the srugery
Knee injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR)
The KOOS, JR is a 7-item instrument that includes 3 of the 5 subscales from the original KOOS (symptoms, pain, and function and daily living). In the KOOS, JR questionnaire, stiffness/ symptom is assessed by 1 item; pain is assessed by 4 items; and function and daily living is assessed by 2 items. These items were assigned a score 0-4 based on the options to the questions (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme). A raw score is summed from the 7 items with a minimum score of 0 and a maximum score of 28. High subscale and raw scores represent worse signs and symptoms. Subsequently, the raw summed score is converted to an interval score out of 100, where 0 represents total knee disability and 100 represents perfect knee health. Using the process, a KOOS, JR score was calculated for each patient included in our study from the original KOOS survey.
The surgery includes primary, revision or partial joint arthroplasty.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The investigators will include the participants who will receive total joint arthroplasty in our institutte.
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
First Submitted
July 16, 2020
First Posted
July 21, 2020
Study Start
September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
The SENSE Study: Surgical ENvironment Stress Evaluation
From the pre-operative assessment until 3 years after the srugery
Contact the study team to confirm eligibility.
August 31, 2023
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 21, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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