HAKA: Routine Follow-up at 10 Years After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?

NCT ID: NCT07070570

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2029-12-31

Brief Summary

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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 guideline. 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). This trial (WP2) investigates the 10-year follow-up, WP1 examines the 1-year follow-up, and WP3 is a qualitative study exploring the experiences and perceptions of patients and healthcare professionals. The aim of the HAKA trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.

Detailed Description

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Conditions

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Hip Arthroplasty, Total Knee Arthroplasty, Total

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Routine Follow-Up (RFU)

Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery

Group Type OTHER

Routine Follow-Up (RFU)

Intervention Type OTHER

Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery

Active Check-Up on Demand (ACOD)

Follow-up care with X-ray, clinical visit and questionnaires at 10 years after surgery when requested by the patient or healthcare provider.

Group Type OTHER

Active Check-Up on Demand (ACOD)

Intervention Type OTHER

X-ray, clinical visit and questionnaires at 10 years after surgery when requested by the patient or healthcare provider.

Passive Check-Up on Demand (PCOD)

X-ray and clinical visit (without questionnaires) at 10 years after surgery when requested by the patient or healthcare provider.

Group Type OTHER

Passive Check-Up on Demand (PCOD)

Intervention Type OTHER

X-ray and clinical visit (without questionnaires) at 10 year when requested by the patient or healthcare provider.

Interventions

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Routine Follow-Up (RFU)

Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery

Intervention Type OTHER

Active Check-Up on Demand (ACOD)

X-ray, clinical visit and questionnaires at 10 years after surgery when requested by the patient or healthcare provider.

Intervention Type OTHER

Passive Check-Up on Demand (PCOD)

X-ray and clinical visit (without questionnaires) at 10 year when requested by the patient or healthcare provider.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Underwent primary THA or TKA approximately 10 years ago
* Age 50 years or older at time of THA or TKA
* Capable and willing to complete questionnaires (when applicable)
* Understanding Dutch or English
* Willing to provide written informed consent in case the patient will complete questionnaires

Exclusion Criteria

* Other indication for surgery than osteoarthritis
* Deceased
* Revision arthroplasty of hip or knee, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THA
* Already participating in this study due to another hip or knee surgery
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JointResearch

OTHER

Sponsor Role collaborator

Tergooi Medical Center

OTHER

Sponsor Role collaborator

Reinier Haga Orthopedisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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J. H. Pasma

Role: CONTACT

079-2065595

Facility Contacts

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J H Pasma

Role: primary

079-2065595

Other Identifiers

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OC-2024-011

Identifier Type: -

Identifier Source: org_study_id

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