NCT05217264

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 18, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

February 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

January 18, 2022

Last Update Submit

July 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Baseline

  • SF-36

    Baseline

  • Forgotten Joint Score

    Baseline

  • High-Activity Arthroplasty Score

    Within a 3-to-5-day period after the first assessment (Second assessment)

Interventions

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.

Eligibility Criteria

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

The patients with a total or unicompartmental knee prosthesis.

You may qualify if:

  • 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Zeynal YASACI, MSc

    Harran University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 1, 2022

Study Start

February 3, 2022

Primary Completion

May 1, 2022

Study Completion

June 20, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations