The Establishment of Total Joint Arthroplasty Registry Database

Arthritis Knee Clinical Trial

Official title:

The Establishment of Total Joint Arthroplasty Registry Database

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04479462
• Other study ID #: 202001045B0
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2020
• Source: Chang Gung Memorial Hospital
• Contact: Feng-Chih Kuo, MD
• Phone: 886-7-7317123
• Email: fongchikuo[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6000
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis Hip
• Arthritis Knee

Intervention

Procedure:
• total joint arthroplasty
The surgery includes primary, revision or partial joint arthroplasty.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.	From the pre-operative assessment until 3 years after the srugery