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

Reinier Haga Orthopedisch Centrum

Status: Not yet enrolling

Conditions: Hip Arthroplasty, Total; Knee Arthroplasty, Total

Treatments: Other: Routine Follow-Up (RFU); Other: Passive Check-Up on Demand (PCOD); Other: Active Check-Up on Demand (ACOD)

Study type: Interventional

Funder types: Other

Identifiers

NCT07070570

OC-2024-011

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 3 patient groups

Routine Follow-Up (RFU)

Other group

Description:

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

Treatment:

Other: Routine Follow-Up (RFU)

Active Check-Up on Demand (ACOD)

Other group

Description:

Follow-up care with X-ray, clinical visit and questionnaires at 10 years after surgery when requested by the patient or healthcare provider.

Treatment:

Other: Active Check-Up on Demand (ACOD)

Passive Check-Up on Demand (PCOD)

Other group

Description:

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

Treatment:

Other: Passive Check-Up on Demand (PCOD)