NCT05211310

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

3.6 years

First QC Date

January 23, 2022

Last Update Submit

December 25, 2023

Conditions

Keywords

Knee Arthroplasty, TotalValidation StudyQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

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.

It is calculated between 0 and 100 points. 0 points indicate severe knee problem, 100 points no knee problem

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.

It is a questionnaire evaluating the quality of life. The higher the total score, the higher the quality of life.

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who have undergone primary total knee arthroplasty surgery at least 6 months ago in the Orthopedics and Traumatology Outpatient Clinic will be included. Participants will be contacted via telephone.

You may qualify if:

  • To have undergone primary total knee arthroplasty for osteoarthritis at least 6 months ago,
  • To be between the ages of 18-65.

You may not qualify if:

  • Having orthopedic, neurological, cardiovascular, or cognitive problems that may affect physical performance,
  • Presence of previous lower extremity surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Afyonkarahisar Health Science University

Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

Emel Taşvuran Horata

Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

Study Officials

  • EMEL TAŞVURAN HORATA, PhD

    AFSU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

EMEL TAŞVURAN HORATA, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Assistant Professor

Study Record Dates

First Submitted

January 23, 2022

First Posted

January 27, 2022

Study Start

May 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations