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

ClinicalTrials.gov ID

NCT06971757

Lead Sponsor

JointResearchOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,000Estimated

Last Update Posted

Nov 18, 2025Actual

Start Date

Jul 1, 2025Actual

Primary Completion Date

Aug 31, 2028Estimated

Completion Date

Dec 31, 2029Estimated

Official Title

Cost-effectiveness of Routine Follow-up at One Year After Total Hip and Knee Arthroplasty Compared to Check-up on Demand: a Multicenter Hybrid Stepped-wedge Cluster De-implementation Study

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 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.

• Hip Arthroplasty, Total
• Knee Arthroplasty, Total

• Routine Follow-Up (RFU)
• Check-Up on Demand (COD)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

JointResearchOTHER

Collaborators

Reinier Haga Orthopedisch CentrumOTHER

Tergooi MCUNKNOWN

Ivanoost@amphia.nl+31 76 595 5000

Y.Kleinlugtenbelt@dz.nl+31 570 535 353

D.colo@adrz.nl+31 88 125 0000

Jesse.kuiper@mzh.nl+31 50 524 5245

Rverhagen@tergooi.nl+31 88 753 1753

K.kremers@cwz.nl+31 24 365 7657

M.vandekerkhove@zzv.nl+31 115 688 000

J.Pasma@rhoc.nl+31 79 206 55 00

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