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The Establishment of Total Joint Arthroplasty Registry Database

The Establishment of Total Joint Arthroplasty Registry Database

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04479462
Enrollment
6000
Registered
2020-07-21
Start date
2020-09-01
Completion date
2023-08-31
Last updated
2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis Hip, Arthritis Knee

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.

Interventions

PROCEDUREtotal joint arthroplasty

The surgery includes primary, revision or partial joint arthroplasty.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PROMIS Global--10 ScoreFrom the pre-operative assessment until 3 years after the srugeryEnrolled 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
Hip disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR)From the pre-operative assessment until 3 years after the srugeryThe 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.
Knee injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR)From the pre-operative assessment until 3 years after the srugeryThe 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.

Countries

Taiwan

Contacts

Primary ContactFeng-Chih Kuo, MD
fongchikuo@cgmh.org.tw886-7-7317123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026