NCT07041528

Brief Summary

After undergoing total hip or total knee arthroplasty, current guidelines recommend routine follow-up with an X-ray within 3 months and again at 1 year. Follow-up at 5 years (for hip arthroplasties) or every 5 years (for knee arthroplasties) is also considered worthwhile according to the guidelines. However, these follow-up appointments require considerable time from patients, caregivers, and healthcare professionals, and it is unclear whether they are truly beneficial. It is possible that a single follow-up within 3 months is sufficient. This could potentially prevent over 100,000 unnecessary hospital visits per year, resulting in significant cost savings. If patients or healthcare providers have concerns, they can always request an additional follow-up. The HAKA trial consists of three different work packages (WPs).The quantitative work packages 1 (WP1) and 2 (WP2) will investigate the 1-year and 10-year follow-up. The qualitative third work package (WP3) will explore and compare the patients' and health care professionals' (HCPs) experiences with, and perceptions about, RFU and COD after total hip and knee arthroplasty. The aim of the overarching HAKA-trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

June 19, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

AftercareArthroplastyFocus GroupsHipInterview [Publication Type]KneeOsteoarthritisPatient Acceptance of Health CareQualitative Research

Outcome Measures

Primary Outcomes (5)

  • The participants' experiences with their follow-up regimen.

    The participants' experiences will be explored using a mix of semi-structured open-ended focus group questions.

    Experiences gained between the baseline clinical visit and a clinical visit one year later.

  • The participants' satisfaction with their follow-up regimen.

    The participants' satisfaction will be explored using a mix of semi-structured open-ended focus group questions.

    Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.

  • The health care professionals' experiences with the different follow-up regimens.

    The health care professionals' experiences will be explored using a mix of semi-structured open-ended interview questions.

    Experiences gained between the baseline clinical visit and a clinical visit one year later.

  • The health care professionals' satisfaction with the different follow-up regimens.

    The health care professionals' satisfaction will be explored using a mix of semi-structured open-ended interview questions.

    Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.

  • The participants' and health care professionals' acceptability of the two different follow-up regimens.

    The participants' and health care professionals' acceptability of the two different follow-up regimens will be explored using a mix of semi-structured open-ended focus group questions.

    Acceptability of follow-up regimens from the baseline clinical visit to a clinical visit one year later.

Study Arms (2)

Routine Follow-up (RFU)

Patients planned for total hip or knee surgery who will receive routinely scheduled follow-ups.

Check-ups on-demand (COD)

Patients planned for total hip or knee surgery who will receive check-ups on-demand.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients after total hip or knee arthroplasty who are enrolled in work package 1 or work package 2 of the main HAKA trial. * Health care professionals who have cared for at least 3 participants from the RFU or COD groups enrolled in work package 1 or work package 2 of the main HAKA trial.

You may qualify if:

  • A good command of the Dutch language

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tergooi MC

Hilversum, Netherlands

Location

Related Publications (55)

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    PMID: 21040336BACKGROUND
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Related Links

MeSH Terms

Conditions

OsteoarthritisPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Dominique C. Baas, PhD

CONTACT

Lex D. de Jong, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2025

First Posted

June 27, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Supporting data-including an overview of all themes, original Dutch quotes from focus groups and interviews, and their English translations-will be compiled in a table and made openly available via an online data repository.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning after publication with no end date.
Access Criteria
Anyone will be able to access the qualitative supportive data via an online data repository.

Locations