Adaptation of High Activity Arthroplasty Score to Turkish

Surgery--Complications Clinical Trial

Official title:

Reliability and Validity of the Turkish Version of the High Activity Arthroplasty Score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217264
• Other study ID #: Observational
• Status: Completed
• Start date: February 3, 2022
• Est. completion date: June 20, 2022

Study information

• Verified date: July 2022
• Source: Harran University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objectives of this study were the translation, cross-cultural adaptation, and assessment of the psychometric properties of the Turkish High-Activity Arthroplasty Score (HAAS) in patients with primary TKA.

Description:

The purpose of this study is to translate and cross-culturally adapt the HAAS instrument into Turkish and investigate its psychometric properties. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of HAAS to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlations with the Turkish version of the KOOS, SF-36 and FJS-12 will determine to check the validity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 20, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Primary THA/TKA due to primary osteoarthritis for >6 months,

2. Age <65

3. To be able to communicate in Turkish

4. Agree to participate in the study

Exclusion Criteria:

1. who do not agree to participate in the study 2- who will undergo 2nd revision TKA 3- who have undergone lower extremity surgery and thus have sequelae 4-having cognitive impairment

Related Conditions & MeSH terms

• Arthropathy
• Joint Diseases
• Physical Disability
• Surgery--Complications

Intervention

Other:
• Assesment
This is a single-center, prospective, observational study. The assessment and reporting will be followed the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist.

Locations

Country	Name	City	State
Turkey	Harran University	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Harran University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High-Activity Arthroplasty Score	The HAAS questionnaire, developed in 2010, is self-reported and comprises the four items walking, running, stair climbing, and the activity level [20]. The response level for each item ranges from normal function to serious limitation. The patient selects the highest possible level of his functional ability for each item. A point system for each item is applied whereby a higher score indicates a higher functional ability. The total score ranges from 0 to 18 points. The original version provides no instruction regarding missing answers.	Baseline,
Secondary	The Knee Injury and Osteoarthritis Outcome Score (KOOS)	The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of a knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used, and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems	Baseline
Secondary	SF-36	The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study. It comprises 36 questions which cover eight domains of health: Limitations in physical activities because of health problems.; Limitations in social activities because of physical or emotional problems; Limitations in usual role activities because of physical health problems; Bodily pain; General mental health (psychological distress and well-being); Limitations in usual role activities because of emotional problems; Vitality (energy and fatigue); General health perceptions	Baseline
Secondary	Forgotten Joint Score	The FJS-12 was developed to identify the awareness of an artificial joint (hip or knee) during activities of daily living. It uses a 5-point Likert response format (0, never; 1, almost; 2, seldom; 3, sometimes; and 4, mostly) consisting of 12 items that assess "the patient's ability to forget the artificial joint in everyday life" following activities of daily living -in bed at night; sitting in a chair (>1hr); walking (>15 min); taking bath; traveling in a car; climbing stairs; walking on uneven ground; standing up from a low sitting position; standing for long periods; doing housework or gardening; taking a walk or hiking, and involving in a sports activity. The raw scores are transformed to range from 0 to 100 points. High scores indicate a good outcome, which means a high degree of "forgetting" the joint.	Baseline
Secondary	High-Activity Arthroplasty Score	The HAAS questionnaire, developed in 2010, is self-reported and comprises the four items walking, running, stair climbing, and the activity level [20]. The response level for each item ranges from normal function to serious limitation. The patient selects the highest possible level of his functional ability for each item. A point system for each item is applied whereby a higher score indicates a higher functional ability. The total score ranges from 0 to 18 points. The original version provides no instruction regarding missing answers.	Within a 3-to-5-day period after the first assessment (Second assessment)