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Not yet recruiting NCT07070570

HAKA: Routine Follow-up at 10 Years 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), Active Check-Up on Demand (ACOD), Passive Check-Up on Demand (PCOD).
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 →

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 (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.

Interventions

  • Other Routine Follow-Up (RFU)
    Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery
  • 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.
  • 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.

Primary outcome measures

  • Number of complications [Time frame: Assessed until 11 years after implantation]
  • Type of complications [Time frame: Assessed until 11 years after implantation]
  • Healthcare consumption [Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.]
Secondary outcome measures (9)
  • PROMIS Physical Function [Time frame: Assessed at 10 and 11 years after implantation]
  • Number of surgical interventions [Time frame: Assessed until 11 years after implantation]
  • Type of Surgical Interventions [Time frame: Assessed until 11 years after implantation]
  • Number of additional healthcare consumption [Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.]
  • Type of additional healthcare consumption [Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.]
  • Costs related to THA or TKA follow-up [Time frame: Assessed at 10 years after implantation and then after at 3 months, 6 months and 12 months.]
  • Numeric Pain Rating Scale (NPRS) [Time frame: Assessed at 10 and 11 years after implantation]
  • Numeric Satisfaction Rating Scale (NSRS) [Time frame: Assessed at 10 and 11 years after implantation]
  • Health related quality of life (EQ-5D-5L) [Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months]

Eligibility criteria

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

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 · 1 center
  • Reinier Haga Orthopedisch Centrum — Zoetermeer

Identifiers

NCT: NCT07070570 · OC-2024-011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗