- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05217264
Adaptation of High Activity Arthroplasty Score to Turkish
Reliability and Validity of the Turkish Version of the High Activity Arthroplasty Score
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Şanlıurfa, Turkey
- Harran University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Primary THA/TKA due to primary osteoarthritis for >6 months,
- Age <65
- To be able to communicate in Turkish
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
High-Activity Arthroplasty Score
Time Frame: Baseline,
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline
|
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
|
|
SF-36
Time Frame: Baseline
|
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:
|
Baseline
|
|
Forgotten Joint Score
Time Frame: Baseline
|
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
|
|
High-Activity Arthroplasty Score
Time Frame: Within a 3-to-5-day period after the first assessment (Second assessment)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeynal YASACI, MSc, Harran University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Observational
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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