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Clinical Trials/NCT04479462
NCT04479462
Unknown
Not Applicable

The Establishment of Total Joint Arthroplasty Registry Database

Chang Gung Memorial Hospital1 site in 1 country6,000 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthritis Knee
Sponsor
Chang Gung Memorial Hospital
Enrollment
6000
Locations
1
Primary Endpoint
PROMIS Global--10 Score
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study will establish total joint arthroplasty registry database in Kaohsiung Chang Gung Memorial Hospital and collect patient-reported outcome.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
August 31, 2023
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Wang Jun-Wen

Principal Investigator

Chang Gung Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing primary hip or knee arthroplasty
  • Patients undergoing revision hip or knee arthroplasty
  • Patients undergoing partial hip or knee arthroplasty

Exclusion Criteria

  • Incomplete patients' data
  • Follow up less than 1 year after surgery
  • Unwillingness to sign the informed consent

Outcomes

Primary Outcomes

PROMIS Global--10 Score

Time Frame: From the pre-operative assessment until 3 years after the srugery

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

Knee injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR)

Time Frame: From the pre-operative assessment until 3 years after the srugery

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.

Hip disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR)

Time Frame: From the pre-operative assessment until 3 years after the srugery

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.

Study Sites (1)

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