The Establishment of Total Joint Arthroplasty Registry Database

• Conditions: Arthritis Hip; Arthritis Knee

• Registration Number: NCT04479462
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21
• Study Start: 2020-09-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PROMIS Global--10 Score	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)	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)	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.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan