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Recruiting NCT06971757

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

No phase Interventional Hip Arthroplasty, Total Knee Arthroplasty, Total

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine Follow-Up (RFU), Check-Up on Demand (COD).
Who it may be relevant to
Registry conditions: Hip Arthroplasty, Total, Knee Arthroplasty, Total. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other Routine Follow-Up (RFU)
    Standard follow-up care with scheduled X-ray and clinical visit at 3 months and 1 year after surgery.
  • 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.

Primary outcome measures

  • PROMIS Physical Function [Time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.]
  • Number of clinical visits and X-rays [Time frame: From surgery until 24 months after surgery.]
Secondary outcome measures (7)
  • Number of complications [Time frame: From surgery until 24 months after surgery.]
  • Type of Complications [Time frame: From surgery until 24 months after surgery.]
  • Number of surgical interventions [Time frame: From surgery until 24 months after surgery.]
  • Type of Surgical Interventions [Time frame: From surgery until 24 months after surgery]
  • Costs related to THA or TKA follow-up [Time frame: Assessed at 15, 18, and 24 months after surgery.]
  • Numeric Pain Rating Scale (NPRS) [Time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.]
  • EQ-5D-5L [Time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 9 centers
  • OLVG — Amsterdam
  • Amphia — Breda
  • Deventer Ziekenhuis — Deventer
  • Admiraal de Ruyter Ziekenhuis — Goes
  • Martini Ziekenhuis — Groningen
  • Tergooi MC — Hilversum
  • Canisius Wilhelmina Ziekenhuis — Nijmegen
  • ZorgSaam Zeeuws Vlaanderen — Terneuzen
  • … and 1 more center

Publications

  • Rasker AJ, Roubos LAC, Baas DC, Verhagen RAW, de Jong LD, Rutgers M, Vorrink SNW, Pasma JH, Poolman RW, Willigenburg NW. Is check-up on demand non-inferior to routine follow-up at one year after total hip or knee arthroplasty in terms of clinical outcomes and cost-effectiveness? Protocol for a randomized stepped-wedge hybrid effectiveness de-implementation trial. PLoS One. 2026 Mar 17;21(3):e03436 PMID 41843589

Identifiers

NCT: NCT06971757 · NL-009246 · 10330042310003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗