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NCT Number: NCT07070570

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

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.

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Key information

Conditions

Hip Arthroplasty, Total Knee Arthroplasty, Total

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, 2725 NA, Netherlands

Location contact

J H Pasma

CONTACT

[email protected]

079-2065595

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine Follow-Up (RFU)

Other

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

Active Check-Up on Demand (ACOD)

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)

Other

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

Primary outcomes

  1. Number of complications

    Time frame: Assessed until 11 years after implantation

    The total number of post-operative complications per patient will be recorded.

  2. Type of complications

    Time frame: Assessed until 11 years after implantation

    Complication types will be recorded and categorized (e.g., infection, periprosthetic fracture, loosening, malalignment, dislocation, prosthetic wear).

  3. Healthcare consumption

    Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.

    Healthcare consumption related to THA and TKA FU (number of X-rays and clinical visits)

Secondary outcomes

  1. PROMIS Physical Function

    Time frame: Assessed at 10 and 11 years after implantation

    Patient-reported physical functioning will be assessed using the PROMIS® Physical Function Version 1.0, Short Form 10a. The short form consists of 10 items and is expressed by raw summed score ranging from 10 to 50, which can be converted to a T-score and SE. The T-score is a standardized score with a mean of 50 and a SD of 10. Higher T-scores indicate better physical functioning

  2. Number of surgical interventions

    Time frame: Assessed until 11 years after implantation

    The total number of surgical re-interventions per patient related to the index procedure will be recorded.

  3. Type of Surgical Interventions

    Time frame: Assessed until 11 years after implantation

    Types of surgical re-interventions will be recorded and categorized (e.g., DAIR, partial component exchange, full revision, irrigation and debridement without component retention).

  4. Number of additional healthcare consumption

    Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.

    Number of additional healthcare consumption related to THA or TKA FU (like clinical visit, telephone consultations, X-ray, CT scan, MRI scan, laboratory tests)

  5. Type 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 related to THA or TKA FU (like clinical visit, telephone consultations, X-ray, CT scan, MRI scan, laboratory tests)

  6. 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.

    Includes costs from electronic health records and additional patient questionnaires, covering hospital and non-hospital care.

  7. Numeric Pain Rating Scale (NPRS)

    Time frame: Assessed at 10 and 11 years after implantation

    Patient-reported pain intensity, measured using a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores reflect more severe pain.

  8. Numeric Satisfaction Rating Scale (NSRS)

    Time frame: Assessed at 10 and 11 years after implantation

    Numeric Rating Scale for satisfaction (NSRS) will be measured by a single question: "How satisfied are you with the results of the treatment?" The patient will answer this question with a NRS scale ranging from zero to ten. The higher the score, the better.

  9. 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

    Health-related quality of life is measured using the EQ-5D-5L questionnaire. The EQ-5D-5L index score ranges from -0.594 to 1.000, where 1.000 indicates full health, 0 represents death, and negative values represent health states worse than death. Higher scores indicate better health status

Study contacts

Contact information is provided by the study sponsor or research team.

J. H. Pasma

CONTACT

[email protected]

079-2065595

Sponsors and collaborators

Lead sponsor

Reinier Haga Orthopedisch Centrum

Other

Collaborators

  • JointResearch
  • Tergooi Medical Center

Registry information

Acronym: HAKA 10 years

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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