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NCT Number: NCT06971757

HAKA: Routine Follow-Up at 1 Year 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 (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.

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OLVG, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Routine Follow-Up (RFU)

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)

Other

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

Primary outcomes

  1. PROMIS Physical Function

    Time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.

    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 clinical visits and X-rays

    Time frame: From surgery until 24 months after surgery.

    Assesses healthcare consumption based on the number of postoperative outpatient clinical visits and X-ray assessments.

Secondary outcomes

  1. Number of complications

    Time frame: From surgery until 24 months after surgery.

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

  2. Type of Complications

    Time frame: From surgery until 24 months after surgery.

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

  3. Number of surgical interventions

    Time frame: From surgery until 24 months after surgery.

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

  4. Type of Surgical Interventions

    Time frame: From surgery until 24 months after surgery

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

  5. Costs related to THA or TKA follow-up

    Time frame: Assessed at 15, 18, and 24 months after surgery.

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

  6. Numeric Pain Rating Scale (NPRS)

    Time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.

    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.

  7. EQ-5D-5L

    Time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.

    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.

Lidy A.C. Roubos, MSc.

CONTACT

[email protected]

+31 20 599 3653

Sponsors and collaborators

Lead sponsor

JointResearch

Other

Collaborators

  • Reinier Haga Orthopedisch Centrum
  • Tergooi MC

Registry information

Official study 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

Acronym: HAKA 1year FU

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 14, 2025
Registry last updated
Nov 18, 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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