Validity and Reliability of High-Activity Arthroplasty Score

Arthroplasty Complications Clinical Trial

Official title:

Turkish Validity and Reliability of High Activity Arthroplasty Score After Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05211310
• Other study ID #: 2022/2
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: Afyonkarahisar Health Sciences University
• Contact: EMEL TASVURAN HORATA, PhD
• Phone: +905547759663
• Email: ethorata[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score (HAAS) into Turkish and to conduct a validity and reliability study of the Turkish version.

Description:

Studies show that TKA practice has increased in the young population in recent years. Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score into Turkish and to conduct a validity and reliability study of the Turkish version. The adaptation of the questionnaire to Turkish in the study will be made according to the COSMIN and Reliability and Agreement Studies Reporting Guide. The construct validity, concurrent validity, reliability, and floor and ceiling effects of the questionnaire will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• To have undergone primary total knee arthroplasty for osteoarthritis at least 6 months ago,

• To be between the ages of 18-65.

Exclusion Criteria:

• Having orthopedic, neurological, cardiovascular, or cognitive problems that may affect physical performance,

• Presence of previous lower extremity surgery

Related Conditions & MeSH terms

• Arthroplasty Complications

Intervention

Other:
• High-Activity Arthroplasty Score (HAAS)
The questionnaire developed by Talbot et al. in 2010 consists of 4 sub-dimensions. 0-18 points can be obtained from the survey. High scores are associated with higher functional ability.
• Western Ontario and McMaster Universities osteoarthritis score (WOMAC)
It is used to evaluate disability in patients with hip and knee osteoarthritis. Each sub-dimension is standardized within the range of 0-100 points, with high scores indicating poor health.
• The Knee injury and Osteoarthritis Outcome Score (KOOS)
It is calculated between 0 and 100 points. 0 points indicate severe knee problem, 100 points no knee problem
• The Forgotten Joint Score-12 (FJS-12)
It evaluates how much an individual can forget an artificial joint during activities of daily living. A total of 100 points can be obtained. A high score is associated with the ability to forget.
• EQ-5D-5L
It is a questionnaire evaluating the quality of life. The higher the total score, the higher the quality of life.
• Numerical pain scale (NPS)
It is the numerical expression of perceived pain intensity. It is rated from 0-10 points. 10 points indicate the highest pain intensity, 0 points the absence of pain.

Locations

Country	Name	City	State
Turkey	Afyonkarahisar Health Science University	Afyonkarahisar
Turkey	Emel Tasvuran Horata	Afyonkarahisar

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High-Activity Arthroplasty Score (HAAS)	It consists of 4 sub-dimensions (walking, running, climbing stairs and activity level). 0 (min. score) -18 points (max. score) can be obtained from the survey. Higher score is associated with more functional ability	10 minutes