HAKA: Routine Follow-Up at 1 Year After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?

NCT ID: NCT06971757

Last Updated: 2025-11-18

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

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

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 (WP1) investigates the 1-year follow-up, WP2 examines the 10-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

This is a hybrid effectiveness (de-)implementation trial type II, with a stepped-wedge cluster trial design. A total of 10 hospitals will transition from a period with RFU to a period with COD, with a wash-out period (transition) of 2 months. The aim is to gradually de-implement RFU, with all centers eventually using COD as the standard of care.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Routine Follow-Up (RFU)

X-ray and clinical visit within 3 months and at 1 year after surgery.

Group Type OTHER

Routine Follow-Up (RFU)

Intervention Type OTHER

Standard follow-up care with scheduled X-ray and clinical visit at 3 months and 1 year after surgery.

Check-Up on Demand (COD)

X-ray and clinical visit within 3 months and only at 1 year when requested by the patient or healthcare provider.

Group Type OTHER

Check-Up on Demand (COD)

Intervention Type OTHER

Follow-up care with scheduled X-ray and clinical visit at 3 months and only at 1 year if requested.

Interventions

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Routine Follow-Up (RFU)

Standard follow-up care with scheduled X-ray and clinical visit at 3 months and 1 year after surgery.

Intervention Type OTHER

Check-Up on Demand (COD)

Follow-up care with scheduled X-ray and clinical visit at 3 months and only at 1 year if requested.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Painful and disabled hip or knee joint resulting from osteoarthritis
* Scheduled for primary THA or TKA surgery
* Age 50 years or older at the time of THA or TKA
* Capable and willing to complete questionnaires
* Proficient in Dutch or English
* Willing to provide informed consent

Exclusion Criteria

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

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reinier Haga Orthopedisch Centrum

OTHER

Sponsor Role collaborator

Tergooi MC

UNKNOWN

Sponsor Role collaborator

JointResearch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OLVG

Amsterdam, , Netherlands

Site Status RECRUITING

Amphia

Breda, , Netherlands

Site Status RECRUITING

Deventer Ziekenhuis

Deventer, , Netherlands

Site Status RECRUITING

Admiraal de Ruyter Ziekenhuis

Goes, , Netherlands

Site Status RECRUITING

Martini Ziekenhuis

Groningen, , Netherlands

Site Status RECRUITING

Tergooi MC

Hilversum, , Netherlands

Site Status RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status RECRUITING

ZorgSaam Zeeuws Vlaanderen

Terneuzen, , Netherlands

Site Status RECRUITING

RHOC

Zoetermeer, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Lidy A.C. Roubos, MSc.

Role: CONTACT

+31 20 599 3653

Facility Contacts

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Prof. Poolman

Role: primary

+31 20 510 8911

Van Oost, MSc.

Role: primary

+31 76 595 5000

Dr. Kleinlugtenbelt

Role: primary

+31 570 535 353

Dr. Colo

Role: primary

+31 88 125 0000

Dr. Kuiper

Role: primary

+31 50 524 5245

Dr. Verhagen

Role: primary

+31 88 753 1753

Kremers, MSc.

Role: primary

+31 24 365 7657

M. van de Kerkhove

Role: primary

+31 115 688 000

Dr. Pasma

Role: primary

+31 79 206 55 00

Related Links

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Other Identifiers

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10330042310003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL-009246

Identifier Type: -

Identifier Source: org_study_id

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